Evaluation of OSSIX-Plus Resorbable Collagen Membranes for Alveolar Ridge Preservation Following Exodontia

NCT ID: NCT00639860

Last Updated: 2016-03-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-03-31
• Study Completion Date: 2009-03-31

Brief Summary

The purpose of this study is to evaluate clinically, histologically and radiographically the healing of extraction sockets covered with a resorbable collagen membrane (OSSIX-Plus) 12 weeks following exodontia.

Detailed Description

Reduction in alveolar ridge height and width may prohibit optimal implant placement, and often compromises the esthetic and functional result. Alveolar ridge preservation has been evaluated in many studies. A variety of bone grafting materials and barrier membranes have been studied for their ability to enhance bone formation in damaged alveolar ridges, and to evaluate their bone healing and bone-forming capacity in extraction sockets. However, the newly developed resorbable collagen membrane OSSIX-Plus has not been evaluated for this purpose. This study is designed to test the ability of OSSIX-Plus (OraPharma Inc., Warminster, Pennsylvania) in promoting optimal bone healing following exodontia. We hypothesize that use of OSSIX-Plus will result in preservation of the height, width and density of the residual alveolar ridge following tooth extraction.

Conditions

Alveolar Bone Loss; Loss of Teeth Due to Extraction; Edentulous Alveolar Ridge

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Placing OSSIX-Plus in Extraction Site

Placement of OSSIX-Plus, a resorbable collagen membrane, and the promotion of bone healing following exodontia.

Group Type: EXPERIMENTAL

OSSIX-Plus

Intervention Type: DEVICE

resorbable collagen membrane

Interventions

OSSIX-Plus

resorbable collagen membrane

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Systemically healthy subjects with 1 maxillary premolar tooth requiring extraction
• Residual extraction sockets must have < 80% bone loss in all dimensions (3 or 4-walled bony defects)
• Nonsmokers (individuals who quit smoking at least 6 months prior to the study will be allowed to participate)
• Subjects willing and able to comply with all study-related procedures including maintenance of good oral hygiene and compliance with re-evaluation appointments
• Subjects who read, understand and are willing to sign an informed consent statement

Exclusion Criteria

• Inadequate zone of keratinized gingiva (KG) or alveolar mucosa to obtain primary wound closure of the surgical site
• Presence of acute infections at the time of tooth extraction
• Clinically significant or unstable (as defined by the investigators) systemic diseases affecting bone or soft tissue growth or other renal, hepatic, cardiac, endocrine, hematological, autoimmune or acute infectious diseases that makes interpretation of the data more difficult
• History of head & neck radiation therapy
• Subjects taking steroids, tetracycline or tetracycline analogs, bone therapeutic levels of fluorides, biphosphonatesm, medications affecting bone turnover, antibiotics for > 7 days or any investigational drug
• Patients who are or become pregnant during the length of the study
• Sites in which one or both adjacent teeth are missing

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Johnson & Johnson

INDUSTRY

Sponsor Role: collaborator

OraPharma

INDUSTRY

Sponsor Role: collaborator

William Giannobile

OTHER

Sponsor Role: lead

Responsible Party

William Giannobile

William Giannobile, D.D.S., D.Med.Sc.

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

William V Giannobile, DDS, DMedSc

Role: PRINCIPAL_INVESTIGATOR

Professor

Locations

Michigan Center for Oral Health Research

Ann Arbor, Michigan, United States

Countries

United States

References

Neiva R, Pagni G, Duarte F, Park CH, Yi E, Holman LA, Giannobile WV. Analysis of tissue neogenesis in extraction sockets treated with guided bone regeneration: clinical, histologic, and micro-CT results. Int J Periodontics Restorative Dent. 2011 Sep-Oct;31(5):457-69.

Reference Type: RESULT

PMID: 21845241 (View on PubMed)

Other Identifiers

HUM00016574

Identifier Type: -

Identifier Source: org_study_id