Methods for protecting and reparing enamel

1. A method of treating enamel comprising: applying an aqueous-free, enamel protectant and enamel repair, brushing gels containing: stannous fluoride and calcium in a substantivity agent, wherein said substantivity agent is selected from solid and liquid, nonionic poloxamers and combinations thereof, wherein:

(a) Substantivity of said stannous fluoride and calcium into biofilm present on enamel is enhanced through a shift in calcium binding from bidentate to monodentate in the presence of stannous fluoride;

(b) EPF and ERF values of at least 2.5 and 200, respectively, are achieved with periodic administration of said brushing gels onto enamel surfaces with biofilm present;

(c) wherein the stannous fluoride is present in an amount of 400-1100 ppm;

(d) wherein the composition has a pH of 3-5.8;

(e) wherein the calcium content is 0.5-5.0%; and

(f) wherein the calcium is limited to one or more of calcium fumarate, calcium sulfate, calcium gluconate, and mixed sodium and calcium salts of methyl/vinyl/ether/maleic copolymers thereof.

2. A method of treating enamel according to claim 1 , wherein some of said stannous fluoride is present as CaF+.

3. A method of treating enamel according to claim 1 , wherein said substantivity agent contains linear, polymeric polycarboxylate, substantivity enhancers.

4. A method of treating enamel using a brushing gel according to claim 3 , containing stannous fluoride and calcium in a substantivity agent comprising an emulsion of polydimethylsiloxane polymer at viscosities from between about 10,000 cs and about 2.5 million cs as the discontinuous phase in a nonionic, liquid surfactant, continuous phase.

5. A method of treating enamel using brushing gels, according to claim 4 , wherein nonionic liquid poloxamer surfactants, suitable for said brushing gels, are represented by the structural formula:

HO[(C 2 H 4 O) x /(C 3 H 6 O) y ]—[C 3 H 6 O] z —[(C 2 H 4 O) x /(C 3 H 6 O) y ]H

wherein the sum of x, y and z is from between 125 and 175.

6. A method of treating enamel, according to claim 4 , wherein nonionic liquid surfactants, suitable for said brushing gels, are represented by the structural formula:

HO[(C 2 H 4 O) x /(C 3 H 6 O) y ]—[C 3 H 6 O] z —[(C 2 H 4 O) x /(C 3 H 6 O) y ]H

wherein x=76, y=25 and z=56.

7. A method of treating enamel, according claim 1 , using said brushing gel containing unreacted, calcium and phosphate components.

8. A method of treating enamel with an aqueous-free, enamel protectant and enamel repair, brushing gels, featuring monodentate-bidentate bonding of calcium in the presence of stannous fluoride; containing: stannous fluoride, calcium and phosphate components, and a substantivity agent emulsion containing liquid, nonionic, poloxamer surfactant as the continuous phase and polydimethylsiloxane polymer as the discontinuous phase; with an EPF of at least 2.5 and ERF of at least 200;

(a) wherein the stannous fluoride is present in an amount of 400-1100 ppm;

(b) wherein the composition has a pH of 3-5.8;

(c) wherein the calcium content is 0.5-5.0%; and

(d) wherein the calcium is limited to one or more of calcium fumarate, calcium sulfate, calcium gluconate, and mixed sodium and calcium salts of methyl/vinyl/ether/maleic copolymers thereof.

9. A method of treating enamel with brushing gels, according to claim 5 , wherein said polydimethylsiloxane polymer discontinuous phase comprises up to 40% of said emulsion.

10. A method of treating enamel comprising applying an aqueous-free, enamel protectant and enamel repair, brushing gels containing stable stannous fluoride and calcium on a substantivity agent substantive to biofilm coated enamel, wherein said substantivity agent is selected from solid and liquid, nonionic poloxamers and combinations thereof, wherein:

(a) substantivity of said stannous fluoride and calcium into said biofilm is enhanced by a substantivity enhancer and by a shift from bidentate binding of calcium to monodentate in the presence of stable stannous fluoride; and

(b) said stannous fluoride, upon release from said substantivity agent, converts to the moiety CaF which effects EPF and ERF values of at least 2.5 and 200, respectively, wherein:

(c) wherein the stannous fluoride is present in an amount of 400-1100 ppm;

(d) wherein the composition has a pH of 3-5.8;

(e) wherein the calcium content is 0.5-5.0%; and

(f) wherein the calcium is limited to one or more of calcium fumarate, calcium sulfate, calcium gluconate, and mixed sodium and calcium salts of methyl/vinyl/ether/maleic copolymers thereof.

11. A method of treating enamel with brushing gels according to claim 1 , wherein said stannous fluoride, upon release from said substantivity agent, includes a CaF + moiety in the presence of said calcium monodentate binding to said biofilm present on enamel.

12. A method of treating enamel with brushing gels according to claim 1 , wherein the pH of said brushing gel, upon administration to enamel with biofilm, is about 3.

13. A method of treating enamel with brushing gels according to claim 3 , wherein the level of said substantivity agent and said substantivity enhancers is between about 0.5 and about 5% by wt. and about 0.1 and about 3% by wt., respectively.

14. A method of treating enamel with brushing gels according to claim 1 , wherein said ERF values range from between about 380 and about 1070.

15. A method of treating enamel with brushing gels according to claim 3 , wherein said substantivity enhancer has the structural formula:

where m is an integer that provides weight between about 60,000 and about 1,000,000.

16. A method for treating the enamel of “at-risk” patients including:

immunocompromised, cancer therapy, diabetes, COP, mucositis and cardiovascular patients; comprising administering to the patient an aqueous-free enamel protectant and enamel repair brushing gels containing: stannous fluoride, calcium and a substantivity agent emulsion containing nonionic surfactant as the continuous phase and polydimethylsiloxane polymer as the discontinuous phase; comprising administering said gels at a frequency sufficient to effect EPF and ERF values of at least 2.5 and 200, respectively, wherein:

(a) wherein substantivity of said stannous fluoride and calcium into biofilm present on enamel is enhanced through a shift in calcium binding from bidentate to monodentate in the presence of stannous fluoride;

(b) wherein said substantivity agent is selected from solid and liquid, nonionic poloxamers and combinations thereof,

(c) wherein the stannous fluoride is present in an amount of 400-1100 ppm;

(d) wherein the composition has a pH of 3-5.8;

(e) wherein the calcium content is 0.5-5.0%; and

(f) wherein the calcium is limited to one or more of calcium fumarate, calcium sulfate, calcium gluconate, and mixed sodium and calcium salts of methyl/vinyl/ether/maleic copolymers thereof.

17. A method of treating enamel according to claim 1 , wherein: said enamel protectant and repair, brushing gels are administered for up to two minutes, followed by expectoration; at a frequency sufficient to effect EPF and ERF values of at least: 2.5 and 200, respectively.

18. A method of treating enamel according to claim 1 , wherein: enamel protectant and repair, brushing gels are administered: (a) throughout the day as required, and (b) prior to retiring for the evening; thereby establishing EPF and ERF values of at least: 2.5 and 200, respectively.