Endodontic composition and method

• US 3,968,567 A
• Filed: 04/21/1975
• Issued: 07/13/1976
• Est. Priority Date: 04/21/1975
• Status: Expired due to Term

• Current Assignee: Alan J. Nevins
• Original Assignee: Alan J. Nevins
• Inventors: Nevins, Alan J.
• Primary Examiner(s): Peshock, Robert
• Assistant Examiner(s): Lever, Jack Q.
• Application Number:
  US05/569,675
• Time in Patent Office: 449 Days
• Field of Search: 32/15, 32/1, 128/1, 106/149, 106/161, 3/1 R
• US Class Current: 433/224
• CPC Class Codes: A61C 5/50 Implements for filling root canals; Methods or instruments for medication of tooth nerve channels
• CPC Class Codes: A61K 6/54 Filling; Sealing
• CPC Class Codes: A61K 6/876 Calcium oxide
• CPC Class Codes: A61K 6/887 Compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds
• CPC Class Codes: A61K 6/891 Compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
• CPC Class Codes: C08L 23/20 having four to nine carbon atoms
• CPC Class Codes: C08L 7/00 Compositions of natural rubber
• CPC Class Codes: C08L 89/04 Products derived from waste materials, e.g. horn, hoof or hair

Abstract

A composition useful in forming a physiologic root end closure, a method of making the composition and a method utilizing the composition. The composition comprises a buffered solution of colloidal collagen, a calcium salt, a phosphate salt, and optionally, Lugol'"'"'s solution.

Claims

1. A method for causing formation of a physiologic seal across the opening of a rigid, cavity-containing tubular member adjacent capsular connective tissue within a mammalian body comprising

a. filling the tube with a gelable composition comprising collagen, a calcium salt, and a phosphate salt,

b. allowing the composition to gel, and

c. permitting the ingrowth of connective tissue into the cavity.

2. The method of claim 1, wherein the gelable composition comprises collagen, CaCl₂, and K₂ HPO₄.

3. The method of claim 1, wherein the gelable composition comprises collagen, CaCl₂, K₂ HPO₄, and Lugol'"'"'s solution.

4. The method of claim 1, wherein the gelable composition has a pH in the range of about 7.4 - 7.6 and comprises the following materials in the indicated respective proportions by volume:

a. 1.0 - 1.5 ml. of a collagen solution containing from 10 mg. to 60 mg. of collagen in 1 ml. of aqueous buffered solution,

b. 0.05 ml. of an aqueous CaCl₂ solution having a concentration ranging from 40.5 mM to 2.0 M, and

c. 0.05 ml. of aqueous K₂ HPO₄ ranging in concentration from 36.1 mM to 1.8 M.

5. The method of claim 4, wherein the composition additionally contains Lugol'"'"'s solution in an amount sufficient to substantially decrease the gelling time of the composition.

6. The method of claim 5, wherein 0.05 ml. of aqueous 5% Lugol'"'"'s solution is used.

7. A method for closing the root canal of a tooth comprising the steps of

a. excising and removing dead and devitalized tissue from the canal,

b. filling the canal with a composition comprising a buffered aqueous preparation of collagen, a calcium salt and a phosphate salt, and

c. sealing the canal.

8. A method for inducing physiologic closure of a debrided open root canal of a tooth comprising the steps of

a. opening the apical foramen thereof,

b. filling the canal and adjacent opening in periapical tissue, if any, with a gelable composition comprising a buffered aqueous preparation of collagen, a calcium salt and a phosphate salt,

c. sealing the canal, and

d. permitting the ingrowth of connective tissue into the canal of the tooth, followed by mineralization to form a permanent physiologic closure.

9. The method of claim 8, wherein the composition is a high viscosity solution of collagen, calcium chloride and potassium phosphate, adjusted to pH 7.4.

10. The method of claim 9, wherein the composition has a pH in the range of about 7.4 - 7.6 and comprises the following materials in the indicated respective proportions by volume:

a. 1.0 - 1.5 ml. of a collagen solution containing from 10 mg. to 60 mg. of collagen in 1 ml. of aqueous buffered solution,

b. 0.05 ml. of an aqueous CaCl₂ solution having a concentration ranging from 40.5 mM to 2.0 M, and

c. 0.05 ml. of aqueous K₂ HPO₄ ranging in concentration from 36.1 mM to 1.8 M.

11. The method of claim 10, wherein the composition additionally contains 0.05 ml. of aqueous 5% Lugol'"'"'s solution.

12. A composition for use in causing formation of a physiologic closure across the opening of a rigid tubular member adjacent capsular connective tissue within a mammalian body comprising an aqueous solution of collagen, a calcium salt, and a phosphate salt, the solution being buffered to a pH within the range of 7.4 - 7.6 and the solution forming a gel upon standing within about 30 minutes at about 37°

C.

13. The composition according to claim 12, wherein the collagen is reconstituted lyophilized, highly purified calf skin collagen, which is non-antigenic.

14. The composition of claim 12, wherein the calcium salt is calcium chloride and wherein the phosphate salt is K₂ HPO₄.

15. The method of making an endodontic composition comprising mixing at a pH range of about 7.4 - 7.6, the following materials in the indicated respective proportions by volume:

a. 1.0 - 1.5 ml. of a collagen solution containing from 10 mg. to 60 mg. of collagen in 1 ml. of aqueous buffered solution,

b. 0.05 ml. of an aqueous CaCl₂ solution having a concentration ranging from 40.5 mM to 2.0 M, and

c. 0.05 ml. of aqueous K₂ HPO₄ ranging in concentration from 36.1 mM to 1.8 M.

16. The method of claim 15, wherein the materials, after mixing, are placed within an applicator syringe and permitted to gel therein.

17. A gelable endodontic composition comprising the following materials in the indicated respective proportions by volume:

a. 1.0 - 1.5 ml. of a collagen solution containing from 10 mg. to 60 mg. of collagen in 1 ml. of aqueous buffered solution,

b. 0.05 ml. of an aqueous CaCl₂ solution having a concentration ranging from 40.5 mM to 2.0 M, and

c. 0.05 ml. of aqueous K₂ HPO₄ ranging in concentration from 36.1 mM to 1.8 M.

18. The endodontic composition in claim 17, wherein the composition additionally comprises sufficient Lugol'"'"'s solution to substantially decrease the gelling time of the composition.

19. The composition of claim 17, which additionally comprises 0.05 ml. of aqueous 5% Lugol'"'"'s solution.

20. An endodontic composition comprising 1.5 ml. of collagen solution containing 10 mg. collagen per ml. of water and having a pH of 7.6, 0.05 ml. of 2.0 M aqueous CaCl₂ solution buffered to pH 7.4, 0.05 ml. of 1.8 M aqueous K₂ HPO₄ solution buffered to a pH of 7.4 and 0.05 ml. of aqueous 5% Lugol'"'"'s solution.