Method for inducing periodontal tissue regeneration

• US 5,455,041 A
• Filed: 09/13/1993
• Issued: 10/03/1995
• Est. Priority Date: 09/13/1993
• Status: Expired due to Fees

• Current Assignee: The Research Foundation for The State University of New York (State University of New York)
• Original Assignee: The Research Foundation for The State University of New York (State University of New York)
• Inventors: Cho, Moon-Il, Genco, Robert J.
• Primary Examiner(s): Page, Thurman K.
• Assistant Examiner(s): AZPURU, CARLOS A
• Application Number:
  US08/121,041
• Time in Patent Office: 750 Days
• Field of Search: 424/435, 424/451, 424/489, 514/965, 433/215
• US Class Current: 424/435
• CPC Class Codes: A61C 8/0006 Periodontal tissue or bone regeneration support means for endoprosthetic bone substitute or bone graft implants A61F2/2846
• CPC Class Codes: A61K 6/50 Preparations specially adapted for dental root treatment
• CPC Class Codes: A61K 9/0063 Periodont
• CPC Class Codes: C08L 2201/06 Biodegradable
• CPC Class Codes: C08L 27/18 Homopolymers or copolymers or tetrafluoroethene

Abstract

A method for inducing periodontal regeneration including soft tissue, cementum, and bone regeneration, resulting in a type of healing characteristic of the anatomy and architecture of the undiseased tissue, comprising treating the surface of the damaged root with a demineralizing agent, and then applying a growth factor directly to the treated bone surface.

Claims

1. A method for inducing periodontal regeneration in a wound of a mammal with periodontal disease or other condition requiring periodontal regeneration, said method induces soft tissue, cementum and alveolar bone healing of a type characteristic of the anatomy and architecture of undiseased periodontium, comprising the steps of:

a) treating the root surface in the wound with mechanical instrumentation and a composition comprising a demineralizing agent;

b) applying a therapeutically effective amount of a growth factor directly to the treated root surface, wherein said growth factor is one or more factors selected from the group consisting of platelet-derived growth factor in a form having two beta chain (PDGF-BB), platelet-derived growth factor in a form having an alpha and a beta chain (PDGF-AB) and IGF-I;

c) inserting a periodontal barrier, wherein the barrier is positioned between the gingival tissue and the root surface treated according to steps. a) and b) to create and maintain a space for regeneration, and wherein the barrier is selected the group consisting of a membrane, a biodegradable polymer, and a biocompatible porous material; and

d) closing the wound to allow for regeneration.

2. The method of claim 1, wherein the composition further comprises a vehicle, such as a gel, with adherent and viscohs properties to enhance the binding, retention time, and activity of the demineralizing agent to the root surface.

3. The method of claim 2, wherein the composition further comprises a therapeutically effective amount of a growth factor thereby obviating the need to apply the growth factor in a separate step of the method, said vehicle also enhances the binding, retention time, and activity of the growth factor,

4. The method of claim 1, wherein the demineralizing agent comprises citric acid.

5. The method of claim 1, wherein the growth factor is PDGF-BB.

6. The method of claim 1, wherein the wound consists of Class III furcation lesions or other periodontal tissue defects which result from periodontal disease, or other destructive or traumatic process to the periodontal tissue.

7. A method for inducing regeneration in a wound site comprising damaged bone, periodontium, connective tissue, or ligament of a mammal, said method induces soft tissue and bone regeneration resulting in soft tissue, cementum and bone characteristic of the anatomy and architecture of undamaged tissue in the regeneration site of the mammal, comprising the steps of:

a) treating damaged root surface in the wound site with mechanical instrumentation and a composition comprising a demineralizing agent;

b) applying a therapeutically effective amount of a growth factor directly to the treated root surface, wherein said growth factor is one or more factors selected from the group consisting of platelet-derived growth factor in a form having two beta chain (PDGF-BB), platelet-derived growth factor in a form having an alpha and a beta chain (PDGF-AB) and IGF-I;

c) inserting a barrier, wherein the barrier is positioned between the surrounding tissue of the wound site and the root surface treated according to steps a) and b) to create and maintain a space for regeneration, and wherein the barrier is selected the group consisting of a membrane, a biodegradable polymer, and a biocompatible porous material; and

d) closing the wound to allow for regeneration.

8. The method of claim 7, wherein the composition further comprises a vehicle, such as a gel, with adherent and viscous properties to enhance the binding and retention time of the demineralizing agent to the root surface.

9. The method of claim 8, wherein the composition further comprises a therapeutically effective amount of a growth factor thereby obviating the need to apply the growth factor in a separate step of the method.

10. The method of claim 7, wherein the demineralizing agent comprises citric acid.

11. The method of claim 7, wherein the growth factor is PDGF-BB.