Patent Application
20240207015
This invention relates to improvements in dentistry, more particularly to methods, compositions and devices which help to prevent or reduce aerosol generation during dental procedures.
Repeated exposure to micro-organisms present in blood and saliva during aerosol-generating procedures (AGP's) places the dental professional at risk for developing infectious diseases and occupational acquired respiratory conditions (King et al 1997, Bennett 2000, Szymanska 2007, Reddy et al 2015). The transmission of SARS-CoV-2 via aerosolization of airborne droplets of <5 μm has been identified as a potential risk (Peng et al, 2020) arising from common medical and dental procedures (Public Health England, 2020). Dentists, dental hygienists, and dental therapists together with dental nurses are in the highest risk category of COVID-19 due to the physical proximity to the oral cavity during aerosol and non-aerosol generating procedures with the average distance of the operator eyes to oral the cavity measuring just 35-40 cm (Pirvu et al, 2014).
There are numerous potential sources of airborne contamination during dental treatment: dental instrumentation, saliva and respiratory sources, and the operative site. Most dental procedures require the use of rotary or ultrasonic devices that produce airborne particles from the site where the instrument is used. The atomised particles create a fine mist or cloud, referred to as aerosol, that poses a serious risk (Meng, 2020) to dental personnel and patients. Fine particles, those measuring <10 μm in diameter are of most concern and carry the greatest risk due to their size, prolonged suspension in the air and ability access the nostrils, mouth, eyes, and skin and penetrate the respiratory system (Harrel & Molinari, 2004).
Aerosol-generating devices commonly used are highspeed handpieces that operate at ˜400,000 revolutions per minute for cutting teeth and caries removal, and ultrasonic scalers (frequency range of 27-40 KHz) that are used for the disruption and removal of oral biofilm and calculus in the treatment of periodontal disease. These devices rely on water as a coolant and when mixed with air, the water is atomised into a fine mist of particles and droplets of varying size and velocity. These devices can entrain potentially infected body fluids and debris within the aerosol created. Ultrasonic procedures generate the greatest aerosol, followed closely by highspeed air-turbines (Veena et al 2015, Bennett et al 2000). It is for this reason that the use of devices creating fine aerosol particles <10 μm are currently restricted and avoided and classed according to risk and aerosol production during the Sars-Cov2 pandemic by regulatory bodies.
Recent work confirms that contaminated aerosol and splatter, as result of both procedures is highest closest to the source (within 2m) but may also travel considerable distances from the source (low levels detected at 4 m) and beyond the confines of the clinical area (Allison et al 2020) contaminating surfaces remote from the immediate area where treatment is being carried out.
Splatter (also referred to as “spatter”) is a much larger particle, 50 μm or more in diameter and exits the source in a trajectory manner and stops when it encounters a surface or falls to the ground. The trajectory is akin to the ballistic manner of a fired bullet. Splatter is a mixture of air, contaminated water, and bodily fluids are found in particles between 50 μm to several millimetres in diameter. These larger and heavier splatter particles do not stay suspended in the air for as long as smaller particles <10 μm diameter and are less of a problem.
As a result of Covid-19 dental infection risk, access to many dental treatments has been limited, with aerosol generating procedures only undertaken when deemed essential, resulting in postponed appointments, delayed treatment and progression of odontogenic infections, pain, and extractions of teeth that in normal circumstances would have been salvageable. Furthermore, the current common practice of prescribing antibiotics in lieu of appropriate treatment is of limited short-term benefit for patients and may have long term ramifications for antimicrobial resistance. Despite initiatives to recommence normal dental services, the cost and availability of PPE, as well as fallow and decontamination times have become limiting factors, disproportionately affecting primary care practices (Izzetti et al, 2020).
Solutions which permit the safe practice of dentistry, particularly using rotary and ultrasonic instrumentation, are therefore required.
The present invention provides a method of cooling a device for use in dentistry, the method comprising delivering a coolant to a working end of the device, the coolant comprising a Newtonian fluid having a viscosity greater than water.
The present invention also provides a method of cooling a device for use in dentistry, the method comprising delivering a coolant to a working end of the device, the coolant comprising glycerine.
The present invention also provides a coolant for use in a method of cooling a device for use in dentistry, the method comprising delivering the coolant to a working end of the device, the coolant comprising a Newtonian fluid having a viscosity greater than water.
The present invention also provides a coolant for use in a method of cooling a device for use in dentistry, the method comprising delivering the coolant to a working end of the device, the coolant comprising glycerine.
The present invention also provides a coolant for cooling a device for use in dentistry, the coolant comprising a Newtonian fluid having a viscosity greater than water.
The present invention also provides a coolant for cooling a device for use in dentistry, the coolant comprising glycerine.
The present invention also provides an apparatus for use in dentistry, the apparatus comprising a coolant reservoir comprising a coolant as hereinbefore described, and a device connected to the coolant reservoir for delivery of coolant to a working end of the device to cool the device.
The present invention also provides a kit for use in dentistry, the kit comprising a coolant as hereinbefore described, and a device for use in dentistry.
The present invention also provides a coupling for connecting an alternative liquid coolant to a handpiece for use in dentistry, the coupling comprising:
The present invention also provides an apparatus for use in dentistry, the apparatus comprising a first coolant reservoir comprising a first liquid coolant, an alternative coolant reservoir comprising an alternative liquid coolant different from the first liquid coolant, and a handpiece, wherein the handpiece is connected to the first coolant reservoir and the alternative coolant reservoir via a coupling as hereinbefore described.
The present invention also provides an apparatus for use in dentistry comprising:
The present invention also provides an apparatus for use in dentistry comprising:
The present invention also provides a tip for a vibrating scaler for use in dentistry, the tip comprising:
The present invention also provides a vibrating scaler for use in dentistry, comprising a scaler handpiece connected to a tip as hereinbefore described.
Throughout the description and claims of this specification, the words “comprise” and “contain” and variations of the words, for example “comprising” and “comprises”, mean “including but not limited to”, and do not exclude other components, integers or steps. Moreover the singular encompasses the plural unless the context otherwise requires: in particular, where the indefinite article is used, the specification is to be understood as contemplating plurality as well as singularity, unless the context requires otherwise.
Preferred features of each aspect of the invention may be as described in connection with any of the other aspects. Within the scope of this application it is expressly intended that the various aspects, embodiments, examples and alternatives set out in the preceding paragraphs, in the claims and/or in the following description and drawings, and in particular the individual features thereof, may be taken independently or in any combination. That is, all embodiments and/or features of any embodiment can be combined in any way and/or combination, unless such features are incompatible.
One or more embodiments of the invention will now be described, by way of example only, with reference to the accompanying drawings, in which:
The present invention provides methods, compositions and devices which provide improvements in dentistry. Advantageously, the various aspects of the invention enable the prevention or reduction of aerosol generation during dental procedures, along with providing other improvements in performance.
Rotary and ultrasonic devices are routinely used for most dental procedures. The operator/clinician holds the dental device by the handpiece. The moving or working/cutting/scaling endpiece is attached. The rotary or vibrating tip or bur is routinely showered in atomised water to keep it cool during operation. The methods, compositions and devices described herein act to encapsulate the working end of the device within a fluid shield/barrier, and may be used alone. This fluid shield surrounds the working end (tip/bur) of the device and captures aerosol particles and debris that may be generated during the dental procedure, thus reducing the risk of transmission and inhalation of bioaerosols when using the devices. The methods, compositions and devices described herein may be used alone or in any combination to achieve this.
As used herein, the term spatter refers to droplets from 50 μm to several millimeters in diameter. The term “spatter” is used interchangeably with the term “splatter”.
As used herein, the term aerosol refers to droplets less than 50 μm in diameter. Fine aerosols are droplets less than 10 μm in diameter. Very fine aerosols are droplets less than 5 μm in diameter.
The present invention provides a method of cooling a device for use in dentistry, the method comprising delivering a coolant to a working end of the device, the coolant comprising a Newtonian fluid having a viscosity greater than water.
It has been surprisingly found that use of a coolant comprising a Newtonian fluid that is more viscous than water to cool dental devices advantageously suppresses, and may completely eliminate, aerosolization compared to use of water. The higher viscosity means that the coolant has a tendency to form a fluid shield around the working end of the device, which traps potential aerosol particles and debris. Other potential advantages conferred by use of the modified coolant include improved device performance (e.g. by increasing cavitation when used with an ultrasonic scaler), noise reduction, and lower patient sensitivity to the coolant. Less coolant may also be required compared to water, potentially because inclusion of a more viscous fluid leads to lower evaporation from the coolant.
As used herein, the term dentistry refers to procedures carried out on the teeth, gums and oral cavity. Dentistry includes the diagnosis, prevention and treatment of diseases, conditions and disorders of the teeth, gums and oral cavity and also includes cosmetic procedures, that is, procedures primarily carried out to improve the appearance of the teeth, gums or oral cavity.
The device for use in dentistry may preferably comprise a handpiece and may optionally further comprise an endpiece connected to the handpiece. As used herein the term handpiece refers to a hand-held instrument used to perform a variety of dental procedures. The handpiece can provide resources (e.g. energy, coolant, air) to an endpiece. As used herein the term endpiece refers to a component that connects to a handpiece for performing a specific dental procedure.
As used herein, the term working end refers to the portion (generally the free end) of the device that carries out the function of the device. The working end of a handpiece may be the end of the handpiece that connects to an endpiece in use. The working end of an endpiece may be considered to be the distal portion (generally the free end) of the endpiece that in use is held in close proximity to, or in contact with, the dental (e.g. tooth) surface being treated. When a handpiece is connected to an endpiece, the working end of the device is generally considered to be the working end of the endpiece.
Types of dental handpieces include, but are not limited to, rotary handpieces, that provide rotational energy to an endpiece, and scaler handpieces, that provide vibrational energy to an endpiece. Rotary handpieces include low speed handpieces (handpieces that rotate at up to about 140,000 rpm) and highspeed handpieces (handpieces that rotate at about 180,000-450,000 rpm). The rotary motion of highspeed handpieces (HSS) may be electric or air-driven. Endpieces typically used with a highspeed handpiece include dental burs. Scaler handpieces include sonic scaler handpieces (that operate at a frequency of about 3,000-9,000 Hz) and ultrasonic scaler handpieces (that operate at a frequency of about 20 to 50 kHz). Ultrasonic scaler (USS) handpieces may be magneto-strictive or piezoelectric. Endpieces typically used with an ultrasonic scaler handpiece include scaler tips.
Highspeed handpieces may be used in combination with dental burs for drilling procedures. Ultrasonic handpieces may be used in combination with scaler tips for ultrasonic scaling procedures. The method of the present invention is particularly effective in cooling highspeed handpieces (e.g. in combination with dental burs) and ultrasonic scaler handpieces (e.g. in combination with scaler tips).
As used herein, viscosity refers to dynamic viscosity unless otherwise indicated. Viscosity may be measured using a viscometer, for example using a rotational viscometer according to the DIN 53019-1 standard. Viscosity may preferably be measured at room temperature, e.g. at a temperature of 20° C. Viscosity may preferably be measured at a rotational speed of 10 RPM. The viscosity of water under these conditions is 1.0005 cP. The viscosity may be measured in centipoise (cP). 1 centipoise is equal to 1 millipascal second (mPa·s).
The method of the invention utilizes a coolant comprising a Newtonian fluid having a viscosity greater than water. The viscosity of the Newtonian fluid may preferably be at least 20 cP, at least 25 cP, at least 50 cP, at least 100 cP, at least 250 cP, at least 500 cP, at least 750 cP or at least 1000 cP. The viscosity of the Newtonian fluid may preferably be less than 3000 cP, less than 2500 cP, less than 2000 cP, less than 1500 cP or less than 1000 cP. The viscosity of the Newtonian fluid may preferably be from 20 cP to 3000 cP, from 25 cP to 2500 cP, from 50 cP to 2000 cP, from 100 cP to 1500 cP or from 250 cP to 1000 cP, for example from 500 to 2000 cP or from 750 cP to 1500 cP.
The coolant in the method of the invention preferably has a viscosity greater than water. The viscosity of the coolant may preferably be least 5 cP, at least 10 cP, at least 20 cP, at least 30 cP, at least 50 cP, at least 100 cP, at least 150 cP, at least 200 cP, at least 250 cP or at least 300 cP. The viscosity of the coolant may preferably be less than 3000 cP, less than 2000 cP, less than 1750 cP, less than 1500 cP, less than 1250 cP, less than 1000 cP, less than 750 cP, less than 500 cP, less than 400 cP, less than 350 cP, less than 300 cP, less than 250 cP, less than 200 cP, less than 150 cP, less than 100 cP or less than 75 cP. The viscosity of the coolant may preferably be from 5 cP to 2000 cP, from 10 cP to 1750 cP, from 20 cP to 1500 cP, from 30 cP to 1250 cP, from 50 cP to 1000 cP, from 100 cP to 750 cP, from 150 cP to 500 cP, from 200 cP to 400 cP, or from 250 cP to 350 cP, for example from 25 cP to 3000 cP.
A higher viscosity coolant may advantageously provide greater aerosol and/or spatter prevention but may require modifications to dental devices and associated apparatus (e.g. pumps) to use. At very high viscosities the coolant may not flow adequately to perform its function. On the other hand, lower viscosity coolants may advantageously be compatible with existing dental devices without the need for any modification but may not provide as effective aerosol and/or spatter suppression. Higher viscosities may also provide additional benefits, for example increased cavitation when used with ultrasonic scalers, and noise suppression. The optimum viscosity of the coolant may therefore vary depending on the desired outcome.
The optimum viscosity of the coolant may also differ depending on the dental device, procedure or conditions. For example, it has been discovered that a higher minimum viscosity may be required for use with a highspeed handpiece than for an ultrasonic scaler handpiece. Without wishing to be bound by theory, it is thought that this is because the tip of an ultrasonic scaler oscillates whilst the bur in a high speed handpiece rotates. The angular velocity/centrifugal force created by this rotation can cause coolant to accelerate away from the rotating bur, and thus may require a more viscous liquid to suppress aerosol creation than the oscillating ultrasonic scaler tip. Additionally, highspeed handpieces can operate at approximately 400,000 revolutions per minute (˜7,000 rps) and require 50 ml per minute of coolant flow. By comparison, ultrasonic scaler tips move at ˜800-1000 oscillations per second and require 14-30 ml/min of coolant flow. Thus, high-speed handpieces have potential to generate more aerosol than ultrasonic scalers, and thus a higher viscosity coolant may be required to eliminate aerosols.
For use with an ultrasonic scaler the viscosity of the coolant may be at least 20 cP, at least 25 cP, at least 30 cP, at least 50 cP or at least 100 cP. For use with an ultrasonic scaler the viscosity of the coolant may be less than 500 cP, less than 400 cP, less than 350 cP, less than 300 cP, less than 250 cP, less than 200 cP, less than 150 cP, less than 100 cP or less than 75 cP. For use with an ultrasonic scaler the viscosity of the coolant may be from 20 cP to 500 cP, from 25 cP to 400 cP, from 30 cP to 350 cP, from 50 cP to 300 cP or from 100 cP to 250 cP, e.g. from 20 cP to 150 cP, from 25 cP to 100 cP or from 30 cP to 75 cP.
For use with a highspeed handpiece the viscosity of the coolant may be at least 50 cP, at least 100 cP, at least 150 cP, at least 200 cP or at least 250 cP. For use with a highspeed handpiece the viscosity of the coolant may be less than 2000 cP, less than 1750 cP, less than 1500 cP, less than 1250 cP, less than 1000 cP, less than 750 cP, less than 500 cP, or less than 400 cP. For use with a highspeed handpiece the viscosity of the coolant may be from 50 cP to 2000 cP, from 100 cP to 1750 cP, from 150 cP to 1500 cP, from 200 cP to 1250 cP, or from 250 cP to 1000 cP, e.g. from 50 cP to 750 cP, from 100 cP to 500 cP or from 150 cP to 400 cP.
The method of the present invention utilises a coolant comprising a Newtonian fluid. As used herein, the term Newtonian refers to a fluid which has a viscosity that is independent of the shear rate. Newtonian fluids may therefore be identified by measuring their viscosities at different shear rates. If the viscosity is independent of shear rate then the fluid may be considered to be a Newtonian fluid.
The use of a Newtonian fluid in the coolant confers several advantages, particularly as compared to non-Newtonian fluids and coolants. Non-Newtonian fluids and coolants display a phenomenon known as Weissenberg effect, where pseudoplastic fluids in contact with a rotating rod are drawn upwards. In the case of the high-speed handpiece the rotating bur causes the non-Newtonian solution to be drawn up into the moving mechanical parts of the handpiece including the turbine chamber and exhaust lines, interfering with their action, and clogging moving parts. Newtonian fluids do not display this effect and so are beneficial for use in the coolants of the present invention as they help to prevent or control back flow of the coolant into the device, particularly in the case of highspeed handpieces.
A particularly suitable Newtonian fluid with a viscosity greater than water for inclusion in the coolant is glycerine. Other Newtonian fluids that may be used include, but are not limited to edible oils including vegetable oils such as avocado, canola, grape seed, macadamia nut, olive, peanut, rapeseed, rice bran, safflower, sesame soybean, sunflower and walnut oils. Such oils may be used successfully to suppress aerosol generation as their viscosities are suitable.
Thus the present invention may preferably provide a method of cooling a device for use in dentistry, the method comprising delivering a coolant to a working end of the device, the coolant comprising glycerine.
Glycerine (propane-1,2,3-triol, also known as glycerin or glycerol) provides all the advantages as described above in relation to the non-Newtonian fluid having a viscosity greater than water. Glycerine is a non-toxic compound that is miscible in water. Glycerine has surprisingly been found to confer further advantageous effects, particularly when used in the coolant at relatively high concentrations, including performance benefits, reduction of noise, and patient comfort benefits (reduced sensitivity). Without wishing to be bound by theory, reduced sensitivity may be the result of the much lower thermal conductivity, electrical conductivity, and dielectric constant of glycerine and glycerine solutions in comparison to water. These solutions may also increase mechanical efficiency of the instrument by acting as a lubricant.
In the method of the present invention, the coolant comprises a Newtonian fluid having a viscosity greater than water (preferably glycerine). In some cases, the coolant may preferably consist of the Newtonian fluid (e.g. glycerine). In others, the coolant may preferably further comprise other components.
The coolant may preferably comprise at least 10 wt %, at least 20 wt %, at least 30 wt %, at least 40 wt %, at least 50 wt %, at least 70 wt %, at least 80 wt % or at least 90 wt % of the Newtonian fluid (e.g. glycerine). The coolant may preferably comprise less than 100 wt %, less than 98 wt %, less than 95 wt %, less than 90 wt %, less than 80 wt %, less than 70 wt % or less than 60 wt % of the Newtonian fluid (e.g. glycerine). The coolant may preferably comprise from 10 wt % to 100 wt %, from 20 wt % to 98 wt %, from 30 wt % to 95 wt %, from 40 wt % to 90 wt %, from 40 wt % to 80 wt %, or from 50 wt % to 70 wt % of the Newtonian fluid (e.g. glycerine), e.g. from 30 wt % to 80 wt % or from 40 wt % to 90 wt % of the Newtonian fluid (e.g. glycerine).
Having a greater amount of the Newtonian fluid (e.g. glycerine) may advantageously lead to a higher viscosity coolant.
The coolant may preferably comprise components other than the Newtonian fluid having a viscosity greater than water (e.g. glycerine). Preferably, the coolant further comprises water (e.g. distilled water). The inclusion of water in the coolant alongside the Newtonian fluid (e.g. glycerine) advantageously allows for the viscosity of the coolant to be tuned to the desirable level e.g. to provide acceptable aerosol suppression whilst maintaining the level of flowability required for use with existing dental equipment.
Preferably, the coolant may comprise at least 10 wt %, at least 20 wt %, at least 30 wt %, at least 40 wt %, or at least 50 wt % of water. The coolant may preferably comprise less than 80 wt %, less than 70 wt %, less than 60 wt %, less than 50 wt %, less than 40 wt %, less than 30 wt % or less than 20 wt % of water. The coolant may preferably comprise from 10 wt % to 80 wt %, from 20 wt % to 70 wt %, from 30 wt % to 60 wt %, from 40 wt % to 50 wt % of water e.g. from 10 wt % to 60 wt % of water.
The coolant may further comprise a thickening agent. The thickening agent may preferably be selected from gums (e.g. gum arabic, gum tragacanth, guar gum, locust bean gum), pectin, agar-agar, alginic acid, alginate salts, carrageenan, gelatin, hydroxyethyl cellulose, methyl cellulose, carboxymethyl cellulose (CMC), polyacrylic acid (PAA, also known as Carbomer) and mixtures thereof. Polyacrylic acid may be in the form of a homopolymer or may be crosslinked, for example with an allyl ether such as an allyl ether of pentaerythritol, allyl ether of sucrose, or allyl ether of propylene. Preferred thickening agents include alginic acid, alginate salts, polyacrylic acid and mixtures thereof. Alginate salts are particularly preferred. Alginate salts are advantageously non-toxic, highly soluble in water and can be readily flushed from the inner workings of high speed and ultrasonic dental devices using water. Preferred alginate salts include, but are not limited to, sodium alginate, potassium alginate, calcium alginate, ammonium alginate and mixtures thereof. Sodium alginate is particularly preferred.
When the coolant comprises a thickening agent, the coolant may preferably comprise at least 0.01 wt %, at least 0.05 wt %, at least 0.1 wt %, at least 0.2 wt %, or at least 0.3 wt %, e.g. at least 0.4 wt %, or about 0.5 wt % of the thickening agent. The coolant may preferably comprise less than 10 wt %, less than 5 wt %, less than 3 wt %, less than 2 wt %, less than 1 wt %, less than 0.8 wt % or less than 0.6 wt % of the thickening agent. The coolant may preferably comprise from 0.01 wt % to 10 wt %, from 0.05 wt % to 5 wt %, from 0.1 wt % to 3 wt %, from 0.2 wt % to 2 wt %, from 0.3 wt % to 1 wt % or from 0.4 wt % to 0.8 wt % of the thickening agent, e.g. from 0.1 wt % to 1 wt % of the thickening agent.
As described above, the Weissenberg effect makes pseudoplastic fluids impractical for use as coolants in dental devices, particularly in high-speed handpieces. This makes simple solutions of thickening agents in water unsuitable for use as coolants in the method of the present invention. However, it has surprisingly been found that replacing at least part of the water content in such a solution with a viscous Newtonian fluid such as glycerine delivers the benefits of pseudoplastic fluids while eliminating the disadvantages. As demonstrated in the examples below, such a coolant fluid (e.g. a glycerine/water/sodium alginate mixture) is projected not as an atomized spray but rather as a series of fine, coherent, continuous, unbroken high-speed streams onto the spinning bur when used with a highspeed handpiece. This unexpected and surprising behaviour resembles neither the behaviour of glycerine/water coolants nor aqueous sodium alginate coolant fluids. Adding a thickening agent to a predominately Newtonian fluid (e.g. glycerine)/water solution, produced excellent aerosol suppression without a Weissenberg effect or mechanism clogging deposits.
The inclusion of a thickening agent is thus especially preferred for use with highspeed handpieces. For use with ultrasonic scalers, the coolant may preferably not comprise a thickening agent and may preferably consist of the Newtonian fluid (e.g. glycerine) and water. However, it may in some cases be preferable to include a thickening agent in the coolant for use with an ultrasonic scaler to achieve other benefits, e.g. increased cavitation effects. Some pseudoplastic behaviour of the coolant might also be desirable in some cases when using ultrasonic scalers, e.g. when using devices with less powerful pumps.
The coolant may comprise further additives. An example of a preferred additive is trisodium phosphate (Na3PO4), which may be included when access to effective water purification facilities is limited. Trisodium phosphate when included in coolant solutions captures calcium ions in hard water, preventing the formation of insoluble calcium salts (e.g. calcium alginate) which could clog up pipework in dental devices.
The method of the present invention may preferably not be a method for treatment of the human or animal body by surgery. The method of the present invention may preferably not be a method for treatment of the human or animal body by therapy. The method of the present invention may preferably not be a diagnostic method practised the human or animal body. The method of the present invention may preferably not be a method for treatment of the human or animal body by surgery or therapy. The method of the present invention may preferably not be a method for treatment of the human or animal body by surgery or therapy, nor a diagnostic method practised on the human or animal body.
The method of the present invention may preferably be for the purpose of reducing aerosolization in a dental procedure. The method may preferably reduce aerosolization by at least 50%, at least 75%, at least 80%, at least 85%, at least 90% or at least 95%, compared to use of water as coolant. The reduction in aerosolization may be measured by performing a simulated dental procedure (e.g. as set out in the examples below) using the method of the present invention and comparing the level of aerosolization compared to a control procedure in which water is used as the coolant. Aerosolization may be quantified using high-speed, high-resolution imaging and image/pixel analysis.
The method may further comprise performing a dental procedure with the device whilst it is being cooled.
Preferred dental procedures include, but are not limited to, dental drilling, scaling (e.g. ultrasonic scaling), bonding, orthodontic procedures, crown preparation, post and core preparation, bridge preparation, fitting of bridges, fitting of implants, fitting of crowns, fitting of caps, extractions, fitting of dentures, fillings, gum surgery, root canal treatment, application of dental sealant, teeth whitening, fitting of veneers, filing of teeth, root surface debridement, professional mechanical plaque removal (PMPR), supragingival and subgingival calculus removal, overhang removal, and placement and re-modelling of direct composite resin facings and veneers. Dental drilling and dental scaling (e.g. ultrasonic scaling) are particularly preferred.
Thus, the method of the present invention may preferably be a method of cooling a device for use in dental drilling. Alternatively, the method of the present invention may preferably be a method of cooling a device for use in dental scaling, more preferably ultrasonic scaling.
Dental drilling is a surgical procedure. Dental scaling (e.g. ultrasonic scaling) is not a surgical procedure.
The dental procedure may preferably be a non-surgical and/or a non-therapeutic dental procedure. The dental procedure may preferably be a cosmetic procedure, for example orthodontic procedures, fitting of veneers, fitting of caps, and placement and re-modelling of direct composite resin facings and veneers.
The present invention also provides a coolant for use in a method of cooling a device for use in dentistry, the method comprising delivering the coolant to a working end of the device, the coolant comprising a Newtonian fluid having a viscosity greater than water (e.g. glycerine).
The coolant for use in the method, the method, the device, and the nature of the dentistry may preferably be as hereinbefore described or defined in respect of the method of the present invention.
The present invention also provides a coolant for cooling a device for use in dentistry, the coolant comprising a Newtonian fluid having a viscosity greater than water.
The Newtonian fluid having a viscosity greater than water may preferably be glycerine. Thus, the present invention preferably provides a coolant for cooling a device for use in dentistry, the coolant comprising glycerine.
The coolant of the present invention may preferably be as hereinbefore described or defined in respect of the method of the present invention. Advantages and effects of the coolant composition are as hereinbefore described in respect of the method of the present invention.
The coolant of the present invention is suitable for use in a method of cooling a device for use in dentistry. Coolant compositions that contain toxic ingredients (e.g. alkylene glycols) are not suitable for such use.
A particularly preferred coolant of the present invention comprises (or consists of) glycerine, water and a thickening agent selected from gums (e.g. gum arabic, gum tragacanth, guar gum, locust bean gum), pectin, agar-agar, alginic acid, alginate salts, carrageenan, gelatin, hydroxyethyl cellulose, methyl cellulose, carboxymethyl cellulose (CMC), polyacrylic acid (PAA, also known as Carbomer) and mixtures thereof. Especially preferred thickening agents are polyacrylic acids and alginate salts (e.g. sodium alginate) as described above with respect to the method of the invention. Sodium alginate is particularly preferred. The particularly preferred coolants may optionally further comprise an additive as hereinbefore defined with respect to the method of the invention.
An especially preferred coolant composition of the present invention comprises or consists of:
Another particularly preferred coolant composition of the present invention comprises or consists of:
A further preferred coolant of the present invention comprises or consists of:
These especially preferred coolants have advantageously been found to provide excellent aerosolization suppression, displaying some beneficial non-Newtonian attributes whilst surprisingly not suffering from the drawbacks of the Weissenberg effect when used in combination with a high-speed handpiece. Good compatibility with existing dental devices has also been achieved.
The present invention further provides use of a coolant as hereinbefore defined in a method of cooling a device for use in dentistry, the method comprising delivering the coolant to a working end of the device and further comprising performing a dental procedure with the handpiece whilst it is being cooled. The dental procedure may preferably be as hereinbefore described. The dental procedure may preferably be a therapeutic and/or surgical dental procedure. The dental device may preferably be as hereinbefore described with respect to the method of the invention. The working end may preferably be as herein before defined with respect to the method of the invention.
The present invention also provides an apparatus for use in dentistry, the apparatus comprising a coolant reservoir comprising a coolant as hereinbefore described, and a device connected to the coolant reservoir for delivery of coolant to a working end of the device to cool the device.
In the apparatus of the present invention, the device, coolant and working end may preferably be as hereinbefore defined with respect to the method or coolant of the invention. The device is particularly preferably a highspeed handpiece or an ultrasonic scaler handpiece. The apparatus of the invention may further comprise a power source for driving the device. The device may be connected to the coolant reservoir by any means known in the art, e.g. by tubing. The apparatus may further comprise a control unit for controlling the delivery of coolant from the reservoir to the working end of the device.
The present invention also provides a kit for use in dentistry, the kit comprising a coolant and a device for use in dentistry. The coolant, the device and the nature of the dentistry is each preferably as hereinbefore described. Most preferably, the device comprises and ultrasonic scaler handpiece or a high-speed handpiece.
As described above, the coolants of the present invention are particularly effective when used with a highspeed handpiece or ultrasonic scaler handpiece. Highspeed handpieces in particular are generally used in the dental surgery by attaching to a dentistry base unit, which provides resources such as power, air coolant and liquid coolant to various handpieces attached to the dentistry base unit. The dentistry base unit comprises a liquid coolant reservoir that provides liquid coolant (generally water) for not only the highspeed handpiece but also to other instruments such as slow speed handpiece water spray and three-in-one syringe, used for most dental procedures. Modified coolants would not necessarily be suitable or desirable for use with these other instruments. A standard dentistry base unit is depicted in
The present invention thus also provides a coupling for connecting an alternative liquid coolant to a handpiece for use in dentistry, the coupling comprising:
The coupling of the present invention advantageously allows use of an alternative coolant (e.g. the coolant of the invention hereinbefore described) via existing commercially available handpieces and dentistry base units, without affecting the function of other devices of the dentistry base unit and without requiring further modification of the equipment (e.g. the handpiece and/or dentistry base unit). The coupling may be a separate device for insertion between the handpiece and dentistry base unit, for example between the handpiece and the tubing connecting the handpiece to the dentistry base unit. Alternatively, the coupling may be an integral part of the handpiece, tubing or dentistry base unit.
The auxiliary inlet may be for receiving an alternative liquid coolant connection from an alternative liquid coolant reservoir. The auxiliary inlet is preferably not located at the inlet interface of the coupling. The auxiliary inlet is preferably not located at the outlet interface of the coupling. The first liquid coolant connection may preferably be a water coolant connection. The alternative liquid coolant may be a coolant as hereinbefore described with respect to the method or coolant of the invention.
The coupling of the present invention may preferably comprise a main body and a control unit. The control unit may preferably be for the purpose of controlling the delivery of one or more resources to the handpiece via the resource connections. One or more of the resource connections may preferably pass from the inlet interface to the outlet interface of the main body via the control unit. Other resource connections (e.g. one or more of the resource connections) may preferably pass directly through the main body, without passing through the control unit. The control unit may preferably comprise one or more valves and/or actuators (e.g. one or more servo valves) for controlling the delivery of one or more resources to the handpiece via the resource connections. The one or more valves and/or actuators may preferably be located on one or more of the resource connections within the control unit. When the coupling comprises a main body and a control unit, the main body may preferably comprise the inlet interface and the outlet interface, and the control unit may preferably comprise the auxiliary inlet for receiving the alternative liquid coolant connection.
The coupling of the present invention may advantageously allow for the control of the timing, flow rate and/or delivery mechanism of the resources (e.g. coolant air (chip air), liquid coolant, turbine air) to the handpiece. This may, for example, facilitate the mixing of coolant air and liquid coolant to maximise the effectiveness of the alternative coolant with a highspeed handpiece.
The coupling may be configured to replace the first liquid coolant connection with the alternative liquid coolant connection, such that the alternative liquid coolant connection but not the first liquid coolant connection may be passed on to the handpiece. In this case, the coupling may comprise a termination for the first liquid coolant connection. When the coupling comprises a control unit, the termination for the first liquid coolant connection may be located in the main body of the coupling or in the control unit. The first liquid coolant connection may be terminated by any suitable means available to one of skill in the art, for example the first liquid coolant connection may be capped or otherwise sealed. Thus, the termination may comprise a cap or a seal, preferably at an end of the first liquid coolant connection, e.g. at an end of the first liquid coolant connection distal from the inlet interface and/or at an end of the first liquid coolant connection within the coupling, e.g. within the body or the control unit of the coupling.
Alternatively, the coupling may be configured to allow switching between the first liquid coolant connection and the alternative liquid coolant connection, such that either coolant connection may be passed on to the handpiece. In this case, the coupling may comprise a means for switching between the first liquid coolant connection and the alternative liquid coolant connection. The means for switching between the first liquid coolant connection and the alternative liquid coolant connection may preferably be a valve (e.g. a switching valve). The means for switching between the first liquid coolant connection and the alternative liquid coolant connection may preferably be located on an intersection of the first liquid coolant connection and the alternative liquid coolant connection. When the coupling comprises a control unit, the means for switching between the first liquid coolant connection and the alternative liquid coolant connection may preferably be located in the control unit (i.e. the control unit may preferably comprise the means for switching between the first liquid coolant connection and the alternative liquid coolant connection).
The nature of the resource connections will vary depending on the nature of the handpiece to be used with the coupling but may comprise a turbine air connection (e.g. for air-driven highspeed handpieces), an air coolant connection (“chip air”, e.g. for highspeed handpieces) and/or an electric/power connection. The resource connections may further comprise an exhaust air connection for passing on exhaust air from the handpiece (e.g. highspeed handpiece) to the dentistry base unit where it is vented to the room. The inlet and outlet interfaces are in communication via the resource connections which may, for example, include tubing (e.g. for air and liquid coolant) and/or cables (e.g. for electric/power) for delivery of resources from the dentistry base unit to the handpiece.
Non-limiting exemplary couplings, particularly suitable for use with a highspeed handpiece, are depicted in
In the coupling of
The present invention further provides an apparatus for use in dentistry, the apparatus comprising a first coolant reservoir comprising a first liquid coolant, an alternative coolant reservoir comprising an alternative liquid coolant different from the first liquid coolant, and a handpiece, wherein the handpiece is connected to the first coolant reservoir and the alternative coolant reservoir via a coupling according to any preceding claim. The handpiece is preferably an ultrasonic scaler handpiece or a high-speed handpiece. The first liquid coolant is preferably water. The second liquid coolant is preferably a coolant as hereinbefore described in relation to the method or coolant of the invention.
The present invention also provides an apparatus for use in dentistry, the apparatus comprising:
Traditional dentistry units (such as that shown in
Viscosity may be defined and measured as hereinbefore described in relation to the method of the invention.
The at least one handpiece may be connected to each coolant reservoir for delivery of coolant to a working end of the handpiece to cool the handpiece, or to cool an endpiece attached to the handpiece.
Preferably, the second viscosity is greater than the first viscosity. The second liquid coolant may preferably be a coolant as hereinbefore defined and described in relation to the method of the invention or in relation to the coolant of the invention. The second liquid coolant may preferably comprise glycerine and may optionally further comprise a thickening agent. The thickening agent may preferably be as hereinbefore defined and described in relation to the method or coolant of the invention. The first liquid coolant may preferably comprise (e.g. consist of) water.
The present invention may thus preferably provide an apparatus for use in dentistry comprising:
The at least one handpiece connected to each coolant reservoir may be the same or may be different. The at least one handpiece connected to each coolant reservoir may preferably comprise a first handpiece connected to the first coolant reservoir and a second handpiece connected to the second coolant reservoir. Preferably the at least one handpiece connected to the first coolant reservoir is different from the at least one handpiece connected to the second coolant reservoir. Each handpiece may be as hereinbefore defined and described above in relation to the method of the invention. Preferably, the at least one handpiece connected to the first coolant reservoir comprises (e.g. is) a 3 in 1 syringe handpiece, high speed handpiece, slow speed handpiece, ultrasonic handpiece or a combination thereof, more preferably a 3 in 1 handpiece and/or a slow speed handpiece. The at least one handpiece connected to the second coolant reservoir may preferably comprise a highspeed handpiece and/or an ultrasonic scaler handpiece. More preferably, the at least one handpiece connected to the second coolant reservoir comprises (e.g. is) a highspeed handpiece.
When the at least one handpiece connected to the second coolant reservoir comprises (e.g. is) a highspeed handpiece, the second coolant may preferably be especially suited to use with a highspeed handpiece. Preferred characteristics of such a coolant are as described above with respect to the method or coolant of the invention.
The apparatus of the present invention may further comprise a (e.g. first) coupling as hereinbefore described and defined. The at least one handpiece (e.g. second handpiece) connected to the second coolant reservoir may preferably be connected to the second coolant reservoir via the (e.g. first) coupling. The coupling may preferably be connected to the first coolant reservoir, the second coolant reservoir and at least one handpiece (e.g. the second handpiece). Preferably, the inlet interface of the coupling may be connected to the first coolant reservoir. Preferably, the outlet interface of the coupling may be connected to the at least one handpiece connected to the second coolant reservoir (e.g. the second handpiece). Preferably, the auxiliary inlet of the coupling may be connected to the second coolant reservoir. The at least one handpiece connected to the second coolant reservoir (e.g. the second handpiece) may, therefore, preferably be connected to the second coolant reservoir via a coupling as hereinbefore described and defined. An exemplary, non-limiting, schematic of an apparatus comprising a coupling is shown in
The apparatus of the present invention may preferably further comprise a third coolant reservoir comprising a third liquid coolant having a third viscosity different from the first viscosity, and at least one handpiece (e.g. a third handpiece) connected to the third coolant reservoir. The third viscosity may be the same as or different to the second viscosity but is preferably different to the second viscosity. The third viscosity may preferably be greater than the first viscosity. The third viscosity may preferably be lower than the second viscosity. The third liquid coolant may preferably be a coolant as hereinbefore defined and described in relation to the method or coolant of the invention. The third liquid coolant may preferably comprise glycerine.
The present invention may thus preferably provide an apparatus for use in dentistry comprising:
Preferably the at least one handpiece (e.g. the third handpiece) connected to the third coolant reservoir is different from the at least one handpiece (e.g. the first handpiece) connected to the first coolant reservoir. Preferably the at least one handpiece (e.g. the third handpiece) connected to the third coolant reservoir is different from the at least one handpiece (e.g. the second handpiece) connected to the second coolant reservoir. Preferably, the first, second and third handpieces are all different from one another. The at least one handpiece (e.g. the third handpiece) connected to the third coolant reservoir may be as hereinbefore defined and described above in relation to the method of the invention. The at least one handpiece (e.g. the third handpiece) connected to the third coolant reservoir may preferably comprise an ultrasonic scaler handpiece. When the at least one handpiece connected to the third coolant reservoir comprises (e.g. is) an ultrasonic scaler handpiece, the third coolant may preferably be especially suited to use with an ultrasonic scaler handpiece. Preferred characteristics of such a coolant are as described above with respect to the method or coolant of the invention.
The apparatus of the present invention may further comprise a second coupling. The second coupling may preferably be as hereinbefore described and defined in relation to the coupling of the present invention. The at least one handpiece (e.g. third handpiece) connected to the third coolant reservoir may preferably be connected to the third coolant reservoir via the second coupling. The second coupling may preferably be connected to the first coolant reservoir, the third coolant reservoir and at least one handpiece (e.g. the third handpiece). Preferably, the inlet interface of the second coupling may be connected to the first coolant reservoir. Preferably, the outlet interface of the coupling may be connected to the at least one handpiece connected to the third coolant reservoir (e.g. the third handpiece). Preferably, the auxiliary inlet of the coupling may be connected to the third coolant reservoir. The at least one handpiece connected to the third coolant reservoir (e.g. the third handpiece) may, therefore, preferably be connected to the third coolant reservoir via a second coupling as hereinbefore described and defined. An exemplary, non-limiting, schematic of an apparatus comprising a first and second coupling is shown in
The at least one handpiece (e.g. first handpiece) connected to the first coolant reservoir is preferably not connected to the second reservoir and is preferably also not connected to the third coolant reservoir, where present. The at least one handpiece (e.g. second handpiece) connected to the second coolant reservoir may optionally also be connected to the first coolant reservoir, preferably via a coupling as hereinbefore described (e.g. the first coupling). Alternatively, the at least one handpiece (e.g. second handpiece) connected to the second coolant reservoir may not be connected to the first coolant reservoir. Where a third coolant reservoir is present, the at least one handpiece (e.g. second handpiece) connected to the second coolant reservoir is preferably not connected to the third coolant reservoir. Where present, the at least one handpiece (e.g. third handpiece) connected to the third coolant reservoir may optionally also be connected to the first coolant reservoir, preferably via a coupling as hereinbefore described (e.g. the second coupling). Alternatively, the at least one handpiece (e.g. third handpiece) connected to the third coolant reservoir may not be connected to the first coolant reservoir. Where present, the at least one handpiece (e.g. third handpiece) connected to the third coolant reservoir is preferably not connected to the second coolant reservoir.
The apparatus of the invention may further comprise a source of one or more resources for the handpieces. For examples, the apparatus may further comprise one or more of a source of turbine air, a source of air coolant (chip air), and a source of electric or power. Each source may preferably be connected to one or more of the handpieces.
Physical modifications to devices may also contribute to reducing aerosolization by altering coolant flow patterns and direction of coolant delivery to the working end of the device so that it is encapsulated within a fluid formed shield to reduce aerosol production. In particular, a modified tip for a dental scaler has been developed.
The present invention thus also provides a tip for a vibrating scaler for use in dentistry, the tip comprising:
Generally, standard scaler tips have an outlet on the concave side of the tip (e.g. on the face elevation, underneath the J-bend of the tip). It has surprisingly been found that locating an outlet on the convex side of the tip (e.g. on the top/back elevation of the tip) advantageously helps to focus the flow of the fluid over the back of the tip and to capture and contain (trap) any stray particles of aerosol. Without wishing to be bound by theory, it is believed that modifying the location of the coolant exit in this way allows the fluid to exit on the back elevation of the tip, and flow along the back and down to the working end of the tip in a more consistent manner, forming a fluid shield around the working end of the tip. The modified tip also confers additional advantages beyond aiding aerosol suppression, including increasing the surface area of the tip that the coolant is in contact with, thereby improving cooling, and ensuring that there is sufficient coolant available in the desired area to facilitate the formation of cavitation bubbles to aid effective scaling. The tip of the present invention is particularly effective when used in combination with coolants of the invention as described above.
Preferably, the outlet is located such that coolant delivered therefrom in use can form a flowing liquid shield on the convex side of the tip. Advantageously, this fluid shield captures aerosol particles and debris that may be generated during the scaling procedure, thus reducing the risk of transmission and inhalation of bioaerosols when using the scaler.
The flowing liquid shield may preferably be formed on both the convex and concave side of the tip and may preferably entirely surround the working portion of the tip. Thus the outlet may preferably be located such that coolant delivered therefrom in use can form a flowing liquid shield enveloping the working portion of the tip.
The outlet may preferably be located proximal to the working portion and distal to the inlet. This advantageously aids delivery of the coolant to the working portion of the tip in a controlled manner, thereby helping to form a liquid shield around the working portion for aerosol suppression. In use, the outlet receives coolant from a handpiece via the inlet. The inlet and outlet are thus in fluid communication, for example by a channel or tube.
In preferred tips of the present invention, the tip may comprise a formation for channeling coolant delivered from the outlet in a distal direction on the convex side of the tip. The formation for channeling the coolant may take any suitable form. The outlet may preferably be beveled or chamfered to channel coolant delivered from the outlet in a distal direction, e.g. on the convex side of the tip. Alternatively or additionally, the working portion of the tip may preferably comprise a groove for channeling coolant delivered from the outlet in a distal direction, e.g. on the convex side of the tip. The formation (e.g. beveled/chamfered outlet, and/or groove) advantageously helps deliver coolant in a controlled manner to the working portion (e.g. the working end) of the tip to form a fluid shield.
The tip of the present invention may preferably further comprise a proximal connecting portion for connecting the tip to a scaler handpiece, the working portion extending distally from the connecting portion. In such tips, the connecting portion may preferably comprise a body segment, preferably with a larger cross-section than the working portion, and a shoulder segment connecting the body segment with the working portion. The working portion may thus extend distally from the shoulder segment. The outlet may preferably be located on the shoulder segment of the connecting portion. The shoulder segment may preferably define a beveled or chamfered shape of the outlet. The outlet may be fluidly connected to the inlet by a channel located within the body segment of the connecting portion.
In tips of the present invention comprising a proximal connecting portion, the connecting portion may preferably comprise a longitudinal axis extending from a proximal end of the connecting portion to a distal end of the connecting portion. Preferably, at least part of the working portion diverges from the longitudinal axis of the connecting portion to define the concave side and the convex side of the device. Preferably, the connecting portion is elongate along the longitudinal axis. Preferably, at least a segment of the connecting portion is symmetrical about the longitudinal axis. Preferably, the connecting portion comprises a substantially cylindrical segment.
In tips of the present invention comprising a proximal connecting portion, the inlet may preferably be located on the connecting portion, preferably on a proximal face of the connecting portion. Preferably, the connecting portion comprises an interface for locating and connecting the tip to a scaler handpiece, the interface comprising the inlet. Preferably, the interface further comprises a fastening for fastening the connecting portion to the handpiece to receive vibrations therefrom. The fastening may preferably comprise a threaded portion for fastening the connecting portion to the handpiece by screwing.
The connecting portion may preferably be integral with the working portion of the tip.
In preferred tips of the present invention, the working portion comprises an arcuate segment. The working portion (e.g. the arcuate segment of the working portion) may preferably have a varying radius of curvature. Preferably, the working portion comprises a substantially linear (e.g. linear) segment and an arcuate segment. The arcuate segment of the working portion may be located relatively proximally (e.g. proximal to the connecting portion). The linear segment of the working portion may be located relatively distally (e.g. distal from the connecting portion). The linear segment may extend distally from the arcuate segment. The working portion may thus preferably comprise a relatively proximal arcuate segment and a more distal linear segment extending from the arcuate segment. The arcuate segment of the working portion may extend distally from the shoulder segment of the connecting portion, and the linear segment of the working portion may extend distally from the arcuate segment of the working portion.
The working portion of the tip preferably comprises a resilient material. Suitable resilient materials include, but are not limited to, steel, preferably stainless steel (e.g. medical grade stainless steel), titanium, bronze, copper, gold, teflon, carbon fibre, polyether ether ketone, plastic and mixtures thereof. The working portion of the tip may preferably comprise a metal, e.g. stainless steel. The working portion of the tip is preferably capable of oscillating at an ultrasonic frequency (e.g. at from 20 to 50 kHz, preferably at from 25 to 40 kHz), preferably with a free end of the working portion moving within a displacement amplitude in the range of from 5 to 50 microns. Preferably, the working portion has a resonant frequency within the ultrasonic range (e.g. from 20 to 50 kHz, preferably from 25 to 40 kHz). Preferably, the tip is an ultrasonic scaler tip (e.g. a piezo ultrasonic scaler tip). The tip of the present invention is advantageously particularly suitable for use with ultrasonic scalers as aerosolization is a particular problem with scalers that operate in the ultrasonic range. It also confers additional advantages, such as improved cavitation, that are especially relevant in ultrasonic scaling.
In some preferred tips of the present invention, the tip comprises a further outlet, preferably located on the concave side of the tip. The further outlet may preferably be proximal to the working portion of the tip. The further outlet may be fluidly connected to the inlet by a channel located within the body segment of the connecting portion.
In tips of the invention that comprise a further outlet, the outlets are preferably positioned such that coolant delivered therefrom in use can form a flowing liquid shield enveloping the working portion of the tip. The tip may preferably comprise one or more formations for channeling coolant delivered from the further outlet in a distal direction on the concave side of the tip. The further outlet may be beveled or chamfered to channel coolant delivered from the further outlet in a distal direction on the concave side of the tip. The working portion may comprise a groove on the concave side for channeling coolant delivered from the further outlet in a distal direction on the concave side of the tip. As well as aiding formation of the liquid shield around the working portion of the tip, a further benefit of tips comprising a further outlet is that they may be readily produced from existing scaler tips which generally already have an outlet located on the concave side of the tip.
However, in other cases it may be preferable not to have further outlet, e.g. a further outlet located on the concave side of the device. This may be because an outlet on the concave side of the device may undesirably lead to an increase in aerosol and/or spatter. Thus, in other preferred tips of the present invention, the tip does not comprise a further outlet on the concave side of the device. Preferably the tip does not comprise any further outlets.
The tips of the present invention are designed for use in conjunction with a scaler handpiece. Thus the present invention also provides a vibrating scaler for use in dentistry, comprising a scaler handpiece connected to a tip as hereinbefore described. Preferably, the scaler handpiece is an ultrasonic scaler handpiece. The vibrating scaler may further comprise a coolant reservoir connected to the scaler handpiece. The coolant reservoir may preferably comprise a coolant as hereinbefore described in relation to the method or coolant of the invention.
A non-limiting example of the tip of the present invention is shown in
Referring to
The tip of
The tip (300) is made of a resilient material, enabling displacement (represented by the dashed lines in
These experiments were conducted in a simulated operatory of 12 m2 dimension and serviced by centralised ventilation equivalent of <5 air changes per hour. The ambient temperature remained constant and was recorded at 23° C. The integrated dental unit air pressure was measured and remained constant throughout all testing in the range of 2.3-2.4 bars.
A bespoke rig (see
Piezo-electric ultrasonic dental scaler (27-32 kHz): Tigon Plus by W&H & Periodontal Scaler Tips (2U, 1P and modified tip as shown in
High-speed turbine handpiece (˜400,000 RPM): Synea TG-98L by W&H plus new single use Tungsten Carbide and diamond Burs. The highspeed air-turbine handpiece was positioned parallel to the horizontal plane and secured in place to a micro-meter adjustable rotational stage.
A variety of different concentrations of modified coolants were run through the handpieces during a range of simulated activities to demonstrate results when in contact with a simulated tooth surface, close range of 1 mm from surface, and non-contact position (in the air).
Glycerine: For this work a 99.9% pure Vegetable Glycerine of premium quality USP pharma food grade was used, obtained from Special Ingredients, Unit 4, Foxwood Industrial Park, Chesterfield, S41 9RN.
Sodium Alginate: Pharmaceutical grade sodium alginate was used and was obtained from Sigma Aldrich.
Water: unless otherwise specified, water used in the coolant compositions was distilled water.
Modified coolants: In these tests, unless otherwise specified, the modified coolant used in tests with the highspeed handpiece comprised 50 wt % glycerine, 49.5 wt % water, and 0.5 wt % sodium alginate, and the modified coolant used in tests with the ultrasonic scaler comprised 80 wt % glycerine, and 20 wt % water.
High resolution and high-speed imaging were used to observe coolant behaviour when devices were in contact and in proximity with simulated tooth surface. The coolant sprays were produced under normal procedural conditions whilst observed and recorded using high-speed imaging (Chronos 1.4, Kron Technologies Inc, Canada) with capacity for up to 38,500 fps. Still images were captured using a Sony A6300 camera together with the following lenses and objectives to achieve a magnification of up to 5×. A 35 mm Prime Lens (no zoom/35 mm), 50 mm Prime Lens, 105 mm Prime Macro Lens (Sigma 105 mm 2.8 Macro Lens), 1.4× magnification Lens (Nikon Nikkor ED7 1.4× magnification Lens), 5× magnification Lens and a 5× Microscope Mitotoyo Plan Apochromat objective. Images were qualitatively assessed to understand fluid streaming, atomisation and droplet ejection.
The results with the ultrasonic scaler are shown in
The results with the highspeed handpiece are shown in
In the ultrasonic evaluation, the results demonstrate a significant reduction in aerosol production using the modified coolant and modified tip. The modified coolant forms a flowing liquid shield around the working end of the tip, providing additional tip/coolant contact and encapsulating debris and aerosol within. This effect is enhanced when used in combination with the modified tip. Small residual splatter was observed originating from the existing coolant exit located on the face elevation (underneath the J bend) of the tip. It is believed that this can be eliminated altogether by changing the tip design (sealing up the face exit).
For high-speed handpiece, the results demonstrate that almost complete eradication of aerosol has been achieved and the only splatter that can be seen is after the coolant exits ports at the head of the handpiece and before it touches the tooth surface. This is classed as uncontaminated aerosol during the time when it exits the coolant port and before it encounters the oral tissues, saliva or teeth. No aerosol was detected after the modified coolant contacts the tooth as the coolant adheres to the operative site and remains within the immediate area exhibiting a muco-adhesive like behaviour. The only splatter that is observed is >50 μm and happens before the coolant contacts the tooth surface. In both ultrasonic and high-speed devices, no contaminated aerosol was observed.
In the tests it was observed that the use of a modified coolant produced larger particles known as splatter. These larger particles are heavier and therefore fall to the ground quickly. In all tests, water atomised and extended over a much larger surface area and took longer to settle. The modified coolant produced larger splatter and splashes with no obvious misting compared to water which produced smaller particles in general that travelled much further from the source.
A laser light-scattering test was performed on both devices using modified coolant and water to visualise and image coolant-generated particles and their trajectories (Quarton Green line laser wavelength 510˜530 nm). These tests were performed with both devices in non-contact mode.
The results with the ultrasonic scaler are shown in
The results with the highspeed handpiece are shown in
These results further support those obtained with the high-speed imaging in Example 1.
Highspeed handpiece: A thermocouple sensor (Pico sensor Type K) was secured inside the pulp chamber of five tooth specimens of homogeneous size and form, connected to a six-port data logger (Pico USB TC-08 Thermocouple Data Logger) and compatible computer software to record live thermal changes (PicoLog6 Software). The tooth specimens were mounted to a typodont base and secured in place on a laboratory lifting platform. The specimens were placed inside a water bath with temperature maintained at ˜37° to simulate body temperature. Each sensor was secured in place at a standardised 3 mm from the occlusal surface and cutting tests were directed towards the pulp chamber from the buccal direction. Each cut consisted of one timed, uninterrupted, micro-controlled movement for standardisation. Each cut made was 2 mm in depth in a buccal-occlusal direction. A second sensor was placed in the water bath to record temperature throughout the entire cutting procedure.
Ultrasonic scaler: Three sensors were used to record data for this device. A thermocouple sensor (Pico sensor type K) was secured inside the pulp chamber of five tooth specimens as previously described for high-speed handpiece tests. A second sensor was placed in the water bath to record temperature of the typodont throughout the procedure, and a third sensor positioned at the terminal end of the ultrasonic handpiece. The ultrasonic procedure consisted of a timed uninterrupted scaling activity of 1 minute duration. Tooth (enamel surface) remained stationary and the tip was used as per normal technique, in constant motion and a distance 1-2 mm per stroke, with tip parallel to the long axis of the tooth surface to replicate realistic conditions.
Results for the ultrasonic scaler with 1p tip and water (
Tests were performed in vitro to measure the flow rates per minute of modified coolant compared to water.
Ultrasonic scaler: The ultrasonic device (W&H Tigon Plus) with a frequency of 27-32 kHz was activated for 60 seconds uninterrupted. Power (30) and coolant flow (level 5) settings were standardised for all tests. Each coolant was tested with three different tips (W&H 2U tip, 1P tip, and the modified tip). Distilled water was added to the device tank and flow rate was measured and considered the control. Data for water coolant with a variety of tips was recorded for one minute. Test solution was a modified coolant and all variables remained constant, with flow rate per minute recorded for all three tips. Each test was repeated five times. The minimum coolant flow rate for piezo ultrasonic devices as recommended by manufacturer is 14 ml per minute.
Highspeed handpiece: The recommended flow rate for highspeed handpieces is 50 ml coolant per minute. The highspeed device (W&H Synea TG-98L) has 4 coolant ports and operates at ˜400,000 RPM. Air pressure of 2.4 bar was recorded for this test. A Watson Marlow (Model 5055) peristaltic pump was used to regulate flow rate of the coolant during this test. The flow rate of two coolants, water and a modified coolant (M55-50 wt % glycerine: 49.5 wt % distilled water: 0.5 wt % sodium alginate) were recorded with 5 repeats of each for the purpose of this evaluation.
The results of the flow rate tests are set out below.
These results show that flow rates per minute remained above the minimum requirements during all experiments for both the ultrasonic and highspeed devices.
Noise tests were carried out on the ultrasonic scaler in vitro in the converted clinical surgery. The tests were conducted using a tabletop dental ultrasonic scaling device (W&H Tigon Plus) with a frequency range of 27-32 kH. A new unused 1P tip (W&H) and two coolant liquids were chosen for the purposes of this test. The following settings were selected on the Tigon Plus device for both tests; power setting 30, coolant flow rate 5 and Heat setting of 0. Tooth specimens were prepared and mounted onto a typodont plate and secured to a lifting platform. The ultrasonic device was operator activated with the handpiece at a 45° angle to the horizontal plane. The device tip was positioned parallel to the tooth surface with the terminal 2 mm of the tip in contact. Working noise was simulated by activating the device in a 1-2 mm horizontal movement, keeping the tip in constant motion, using a supragingival biofilm removal technique for 30 seconds uninterrupted. A sound measuring device/microphone Zoom H1 was positioned and secured in place directly above the tip of the ultrasonic scaler at a 20 cm distance. Adobe Audition 2020 was used to record and analyse the data. An exemplary frequency display obtained is shown in
The results of the sound tests performed on the ultrasonic device indicate a reduction in decibels and high-pitched noise. This is a significant finding in terms of clinician safety as well as patient comfort and treatment acceptance.
Viscosity tests were carried out using a Brookfields DVE-HB Viscometer and UL (ultra-low) adapter. Temperature data was recorded for all solutions and revolutions per minute (RPM). Based on our viscosity testing we have created a range of viscosities for each device for aerosol reduction whilst permitting normal function and operation of the devices. Viscosity measurements were carried out according to the DIN 53019-1 standard.
The results of the viscosity testing are shown below in Table 3. “M55” is a coolant composition comprising 50 wt % glycerine: 49.5 wt % distilled water:0.5 wt % sodium alginate. “M55+” is a coolant composition comprising 58.33 wt % glycerine: 41.25 wt % distilled water: 0.416 wt % sodium alginate.
A range of coolant compositions were tested using the methods set out above. Table 4 below sets out key observations made for each composition. Cavitation was observed using high speed imaging with magnification to identify the presence of cavitation bubbles.
The experimental set up is shown in
Particle measurements were undertaken in a bespoke environmental chamber designed to ensure reproducible ambient conditions whilst providing time-resolved measurements of droplet particle sizes and multiple positions throughout instrument use. The chamber comprised of 4 particulate matter sensors Sensirion SPS30 (Sensirion, Switzerland), with a particle count range of 10 μm-0.3 μm and particle mass range 10 μm-1 μm positioned 0.3 m from the source with additional validation conducted with a calibrated 6 channel particle counter, Lasair 5100 (EMS Particle Solutions, UK). All sensors recorded 4 particle concentrations in μg/cm3, and 5 particle counts every second and exported to a data logger (MQTT, Influx DB). A running average of 10 seconds was applied to each data point.
This test is designed to detect every aerosol particle, including the smallest ones, in a tightly controlled environment.
The results are presented in Tables 5A (particle mass) and 5B (particle count). All values reported are the average of six runs.
The results show that the majority of the aerosols generated by ultrasonic scaling are in the smaller than a micron range; still big enough to carry dangerous levels of viruses and pathogens but not mentioned/addressed in the scientific literature.
These results show that an ultrasonic device using water as a coolant creates a significant increase in particle numbers compared with baseline recordings at 0.3 m from the source. Coolant substitution with a 75% aqueous-glycerol solution resulted in a statistically significant reduction (p<0.0001) of particles compared to water (control). A further reduction was achieved with 80% aqueous-glycerol solution compared to 75% (p=0.0016). This demonstrates the efficacy of the modified coolant in reducing aerosolization, including in relation to very fine aerosol particles <5 μm.
The modified coolants achieved over 98% reduction of aerosols in the test conditions. In our experience, with simpler test methods typically used in other studies, or in clinical settings with mitigating factors, the results would be even closer to 100%.
| Number | Date | Country | Kind |
|---|---|---|---|
| 2105926.6 | Apr 2021 | GB | national |
| 2105927.4 | Apr 2021 | GB | national |
| 2105930.8 | Apr 2021 | GB | national |
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/EP2022/060881 | 4/25/2022 | WO |
