Antimicrobial dental appliances including mouthguards and mouthpieces

Information

  • Patent Application
  • 20070267029
  • Publication Number
    20070267029
  • Date Filed
    November 20, 2006
    18 years ago
  • Date Published
    November 22, 2007
    17 years ago
Abstract
The present invention provides for a dental appliance, mouthguard and/or divers mouthpiece using an anti-microbial composition that combines the use of an elastomeric polymer composition with micronized or submicron sized particles of metal or organo/inorgano metal complexes. In addition, the use of an anti-microbial composition for use with a diver's air delivery hose to prevent breathing of contaminated air is also described.
Description

BRIEF DESCRIPTION OF THE DRAWINGS


FIG. 1A is an example of a divers mouthpiece with micronized silver.



FIG. 1B is a sectional view of a bitewing exhibiting the elastomeric polymer with micronized silver additive.





DETAILED DESCRIPTION


FIG. 1A is an example of a divers mouthpiece [100] and bitewing [110] with antimicrobial micronized silver [120] matrixed within an elastomeric polymer [130] composition.



FIG. 1B is a cross-section of a bitewing [110] exhibiting the elastomeric polymer [130] with antimicrobial micronized or submicron sized metal particles of silver including colloidal silver, other suitable metals or metal organo or inorgano complex particles [120].


The following tables relate to the antimicrobial testing that was performed on prototypes of mouthpieces that include the use of micronized silver. The test method performed was ASTM E2180—Standard Method for Determining the Activity of Incorporated Antimicrobial Agent(s) in Polymeric or Hydrophobic Material. The ASTM method E2180 is the method used “to evaluate (quantatively) the effectiveness of agents incorporated or bound into or onto mainly flat (two dimensional) hydrophobic or polymeric surfaces”.


The test organisms utilized were Staphylococcus aureus ATCC 6538 and Pseudomonas aeruginosa ATCC 15442. Two separate agar slurries were prepared, one for each organism. The agar slurries contained 1 mL of the test organism (concentration=7.0×108 cells/mL). 0.85 g NaCl, 0.3 g agar, and 100 mL of deionized water. The final inoculum concentration was equal to ˜7.0×106 cells/mL.


All of the samples were prepared in triplicate and aseptically cut into twelve equally sized pieces. One mL of each agar slurry was applied to the prepared samples. Using both sonification and manual vortexing the agar slurry was immediately removed from one set of the control samples and plate counts were performed. The data recovered was designated as ‘0 hours’.


The remaining set of control samples and the treated material was incubated at 35° C. for 24 hours with the solidified agar slurry intact. The agar slurry was again removed and processed with sonication and vortexing. Plate counts were performed. The data retrieved from this set of samples was designated ‘24 hours’.


Calculation of ‘percent reduction’ compares the geometric mean of each time point data set with that of the relevant time point control. The results are shown in Table 1 below.









TABLE 1







Colony forming units (CFU) collected after treated and untreated polymeric mouthpieces


were exposed to Pseudomonas aeruginosa and Staphylococcus aureus. The colony forming units are


based on the average of three plate counts.











Contact Time ‘0 Hours’
Contact Time ‘24 Hours’













Sample

P. aeruginosa


S. aureus


P. aeruginosa


S. aureus

Percent Reduction













Identification
CFU/mL
CFU/mL
CFU/mL
CFU/mL

P. aeruginosa


S. aureus


















#1
Avg
50,600,000
37,000,000
516,000,000
312,000,000




(Control)
GM
46,773,514
35,481,338
501,187,233
281,838,293


#2
Avg


63,600,000
89,600,000
88%
90%



GM


57,543,993
28,183,829


#3
Avg


43,000,000
3,800,000
95%
99%



GM


20,893,961
1,445,439





Avg: Average of the three triplicate values


GM: Geometric Mean of the three triplicate values (used to calculate % Reduction)






The contol (#1) was for an untreated mouthpiece comprised of silicone rubber. Sample #2 was a separate mouthpiece manufactured using less than 3.5 grams of micronized silver mixed into the silicone rubber prior to injection molding. Sample #3 was another separate mouthpiece manufactured using as much as 3.5 grams of micronized silver mixed into the silicone rubber prior to injection molding. The silver was diluted with the silicone rubber part A used for injection molding. Part B of the silicone rubber used for silicone rubber molding did not have silver added. The micronized silver had been supplied in a tube which included a polysynthetic oil base, such as provided by Artic Silver. In other words, the concentration of micronized silver were significantly lower in sample #2 then in sample #3. One such manufactuer of micronized silver is Artic Silver. They produce micronized silver compounds contianing 99.9% silver including;


Artic Silver 5 that uses three unique shapes and sizes of pure silver particles to maximize particle-to-particle contact area and thermal transfer.


High-Density:


Arctic Silver 5 contains over 88% thermally Conductive filler by weight. In addition to micronized silver, Arctic Silver 5 also contains sub-micron zinc oxide, aluminum oxide and boron nitride particles. These thermally-enhanced ceramic particles improve the compound's performance and long-term stability.


Controlled Triple-Phase Viscosity:


Arctic Silver 5 does not contain any silicone. The suspension fluid is a proprietary mixture of advanced polysynthetic oils that work together to provide three distinctive functional phases. As it comes from the tube, Arctic Silver 5's consistency is engineered for easy application. During the CPU's initial use, the compound thins out to enhance the filling of the microscopic valleys and ensure the best physical contact between the heatsink and the CPU core. Then the compound thickens slightly over the next 50 to 200 hours of use to its final consistency designed for long-term stability.


(This should not be confused with conventional phase change pads that are pre-attached to many heatsinks. Those pads melt each time they get hot then re-solidify when they cool. The viscosity changes that Arctic Silver 5 goes through are much more subtle and ultimately much more effective.)


Not Electrically Conductive:


Arctic Silver 5 was formulated to conduct heat, not electricity. (While much safer than electrically conductive silver and copper greases, Arctic Silver 5 should be kept away from electrical traces, pins, and leads. While it is not electrically conductive, the compound is very slightly capacitive and could potentially cause problems if it bridges two close-proximity electrical paths.)


The product specification for this micronized silver are as follows:


Thermal Conductance:


>350,000W/m2 ° C. (0.001 inch layer)


Thermal Resistance:


<0.0045° C.-in2/Watt (0.001 inch layer)


Average Particle Size:


<0.49 microns <0.000020 inch


Extended Temperature Limits:


Peak: −50° C. to >180° C. Long-Term: −50° C. to 130° C.


Performance:


3 to 12 degrees centigrade lower CPU full load core temperatures than standard thermal compounds or thermal pads when measured with a calibrated thermal diode imbedded in the CPU core.


Table 2 shows the raw data for the triplicate counts for all three mouthpieces described above. It should be understood that these were prototype mouthpieces and that the distribution of the micronized silver was not controlled. Therefore, this initial test and manufacturing process provided surface areas where the silver was not evenly distributed, leading to large variability in bacteria counts. The trends, however, are unmistakable, in that the higher concentration of silver particles within the mouthpiece lead to significantly lower bacteria counts as shown in Tables 1 and 2.









TABLE 2







Raw data for triplicate counts for both samples, at 2 time points,


inoculated with Pseudomonas aeruginosa and Staphylococcus aureus.


(CFU/mL)









Sample
Contact time ‘0 Hours’
Contact Time ‘24 Hours’











Iden-

P. aeruginosa


S. aureus


P. aeruginosa


S. aureus



tification
CFU/mL
CFU/mL
CFU/mL
CFU/mL














#1
67,000,000
35,000,000
450,000,000
476,000,000


(Control)
30,000,000
49,000,000
632,000,000
279,000,000



55,000,000
27,000,000
468,000,000
183,000,000


#2


34,000,000
17,500,000





57,000,000
5,300,000





100,000,000
246,000,000


#3


103,000,000
1,700,000





4,100,000
200,000





22,000,000
9,500,000








Claims
  • 1. A dental appliance including a mouthguard, and/or diver's mouthpiece comprising: a substantially rigid core that provides a shape to said dental appliance, extending from a proximal in-mouth end toward a position short of a distal outside end and at least one back portion comprising bitewings;wherein said dental appliance comprises an elastomeric polymer composition including micronized or submicron sized metal or metal organo or inorgano-complex particles.
  • 2. The dental appliance of claim 1, wherein said metal or metal complexes are comprised of any of the following including; silver, gold, copper, platinum, and/or organo/inorgano complexes of silver, gold, copper, platinum, aluminum oxide, zinc oxide, boron trinitride and the like and wherein said metal or metal oxide may be a colloidal metal.
  • 3. The dental appliance of claim 1, wherein said diver's mouthpiece comprises a passageway with a U-shaped member that forms said mouthpiece with a front portion forming a breathing hole.
  • 4. The dental appliance of claim 1, wherein said elastomeric polymer composition comprises liquid silicone rubbers, other silicone elastomers, fluorinated elastomers, thermoplastic elastomers, polyurethanes, composites of polyvinyl chloride, polyethylene, polypropylene and copolymers of polyethylene and polypropylene, composites including C60 and wherein said elastomeric polymer composition includes micronized or submicron sized particles of metals or metal complexes and wherein said particles may be added before or during a molding process.
  • 5. The dental appliance of claim 1, wherein said micronized metal is provided in a base of polysynthetic oils or a silicone oil or both in preparation for injection molding.
  • 6. The dental appliance of claim 1, wherein said micronized metal is added directly to one or more parts of silicone rubber prior to injection molding.
  • 7. The dental appliance of claim 1, wherein microorganisms including Staphylococcus aureau ATCC 6538 and Pseudomonas aeruginosa ATCC 15442 and/or any other bacteria, mold, fungus, or microorganism growth is reduced or eliminated.
  • 8. A process for making a dental appliance including a mouthguard, and/or diver's mouthpiece comprising: forming a substantially rigid core that provides a shape to said dental appliance, extending from a proximal in-mouth end toward a position short of a distal outside end and at least one back portion comprising bitewings;wherein said dental appliance comprises an elastomeric polymer composition including micronized or submicron sized metal or metal organo or inorgano-complex particles and wherein said metal may be colloidal metal.
  • 9. The process of claim 8, wherein said metal or metal complexes are comprised of any of the following including; silver, gold, copper, platinum, and/or organo/inorgano complexes of silver, gold, copper, platinum, aluminum oxide, zinc oxide, boron trinitride and the like and wherein said metal or metal oxide may be a colloidal metal.
  • 10. The process of claim 8, wherein said diver's mouthpiece comprises a passageway with a U-shaped member that forms said mouthpiece and includes a front portion forming a breathing hole formed during any molding or extrusion operation.
  • 11. The process of claim 8, wherein said elastomeric polymer composition comprises liquid silicone rubbers, other silicone elastomers, fluorinated elastomers, thermoplastic elastomers, polyurethanes, composites of polyvinyl chloride, polyethylene, polypropylene and copolymers of polyethylene and polypropylene, composites including C60 and wherein said elastomeric polymer composition includes micronized or submicron sized particles of metals or metal complexes and wherein said particles may be added before or during a molding process.
  • 12. The process of claim 8, wherein microorganisms including Staphylococcus aureau ATCC 6538 and Pseudomonas aeruginosa ATCC 15442 and/or any other bacteria, mold, fungus, or microorgansim growth is reduced or eliminated.
  • 13. An air delivery hose wherein said air delivery hose may be treated, coated or incorporated into an elastomeric resin concentrate with micronized or submicron sized metal or metal organo or inorgano-complex particles and wherein said metal may be a colloidal metal.
  • 14. A process for making an air delivery hose, as in claim 13, wherein said air delivery hose may be treated, coated or incorporated into the elastomeric resin concentrate with micronized or submicron sized metal or metal organo or inorgano-complex particles.
  • 15. The process as in claim 13, wherein said metal or metal complexes are comprised of any of the the following including; silver, gold, copper, platinum, and/or organo/inorgano complexes of silver, gold, copper, platinum, aluminum oxide, zinc oxide, boron trinitride and the like and wherein said metal or metal oxide may be a colloidal metal.
  • 16. The process as in claim 13, wherein said elastomeric polymer composition comprises liquid silicone rubbers, other silicone elastomers, fluorinated elastomers, thermoplastic elastomers, polyurethanes, composites of polyvinyl chloride, polyethylene, polypropylene and copolymers of polyethylene and polypropylene, composites including C60 and wherein said elastomeric polymer composition includes micronized or submicron sized particles of metals or metal complexes and wherein said particles may be added before or during a molding process.
  • 17. The process as in claim 13, wherein said micronized metal is provided in a base of polysynthetic oils or a silicone oil or both in preparation for injection molding.
  • 18. The process as in claim 13, wherein said micronized metal is added directly to one or more parts of silicone rubber prior to injection molding.
  • 19. The process of claim 13, wherein microorganisms including Staphylococcus aureau ATCC 6538 and Pseudomonas aeruginosa ATCC 15442 and/or any other bacteria, mold, fungus, or microorganism growth is reduced or eliminated.
PRIORITY

This patent application claims priority to pending Provisional application No. 60/801,653 filed May 19, 2006; titled “ANTIMICROBIAL DENTAL APPLIANCES INCLUDING MOUTHGUARDS AND MOUTHPIECES”

Provisional Applications (2)
Number Date Country
60801653 May 2006 US
60814185 Jun 2006 US