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

NCT00639860 | Completed Phase 1 Results

• 1 other identifier: HUM00016574
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

extraction; implant; alveolar ridge preservation

Outcome Measures

Primary Outcomes (5)

• Change in Bone Gain or Loss in Millimeters (Buccopalatal)

  Socket width (buccopalatal) measured by a calibrated examiner using a University of North Carolina (UNC) probe.

  From Baseline to 12 weeks

• Change in Bone Gain or Loss in Millimeters (Mesiodistal)

  Socket width (mesiodistal) measured by a calibrated examiner using a University of North Carolina (UNC) probe.

  From Baseline to 12 weeks

• Change in Bone Gain or Loss in Millimeters (Stent to Apex)

  Stent to apex of socket measured by a calibrated examiner using a University of North Carolina (UNC) probe.

  From Baseline to 12 weeks

• Radiographic Bone Changes

  Radiographic measures were accomplished utilizing a real-time subtraction program, Computer Assisted Radiographic Evaluation (C.A.R.E.).

  From Baseline to 12 weeks

• New Bone Formation

  Percentage of new bone formation of the alveolar bone core biopsies.

  From Baseline to 12 weeks

Study Arms (1)

Placing OSSIX-Plus in Extraction Site

EXPERIMENTAL

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

Device: OSSIX-Plus

Interventions

OSSIX-Plus DEVICE

resorbable collagen membrane

Placing OSSIX-Plus in Extraction Site

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• William Giannobile: lead
• Johnson & Johnson: collaborator
• OraPharma: collaborator

Study Sites (1)

Michigan Center for Oral Health Research

Ann Arbor, Michigan, 48106, United States

Location

Related Publications (1)

• 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.

  PMID: 21845241 RESULT

MeSH Terms

Conditions

Alveolar Bone Loss

Condition Hierarchy (Ancestors)

Bone Resorption; Bone Diseases; Musculoskeletal Diseases; Periodontal Atrophy; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Results Point of Contact

• Title: Dr. William Giannobile, Chair Department of Periodontics and Oral Medicine
• Organization: University of Michigan School of Dentistry

wgiannob@umich.edu

734-763-2105

Study Officials

• William V Giannobile, DDS, DMedSc

  Professor

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: William Giannobile, D.D.S., D.Med.Sc.

Study Record Dates

• First Submitted: March 14, 2008
• First Posted: March 20, 2008
• Study Start: March 1, 2008
• Primary Completion: March 1, 2009
• Study Completion: March 1, 2009
• Last Updated: March 31, 2016
• Results First Posted: March 31, 2016

Record last verified: 2016-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)