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

Primary Purpose

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

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

OSSIX-Plus

About this trial

This is an interventional treatment trial for Alveolar Bone Loss focused on measuring extraction, implant, alveolar ridge preservation

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Michigan Center for Oral Health Research

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Placing OSSIX-Plus in Extraction Site

Arm Description

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

Outcomes

Primary Outcome Measures

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.

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.

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.

Radiographic Bone Changes

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

New Bone Formation

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

Secondary Outcome Measures

Full Information

NCT ID

NCT00639860

First Posted

March 14, 2008

Last Updated

March 1, 2016

Sponsor

William Giannobile

Collaborators

Johnson & Johnson, OraPharma

1. Study Identification

Unique Protocol Identification Number

NCT00639860

Brief Title

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

Acronym

OSSIX

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2016

Overall Recruitment Status

Completed

Study Start Date

March 2008 (undefined)

Primary Completion Date

March 2009 (Actual)

Study Completion Date

March 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

William Giannobile

Collaborators

Johnson & Johnson, OraPharma

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

extraction, implant, alveolar ridge preservation

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

10 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placing OSSIX-Plus in Extraction Site

Arm Type

Experimental

Arm Description

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

Intervention Type

Device

Intervention Name(s)

OSSIX-Plus

Intervention Description

resorbable collagen membrane

Primary Outcome Measure Information:

Title

Change in Bone Gain or Loss in Millimeters (Buccopalatal)

Description

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

Time Frame

From Baseline to 12 weeks

Title

Change in Bone Gain or Loss in Millimeters (Mesiodistal)

Description

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

Time Frame

From Baseline to 12 weeks

Title

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

Description

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

Time Frame

From Baseline to 12 weeks

Title

Radiographic Bone Changes

Description

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

Time Frame

From Baseline to 12 weeks

Title

New Bone Formation

Description

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

Time Frame

From Baseline to 12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

William V Giannobile, DDS, DMedSc

Organizational Affiliation

Professor

Official's Role

Principal Investigator

Facility Information:

Facility Name

Michigan Center for Oral Health Research

City

Ann Arbor

State/Province

Michigan

ZIP/Postal Code

48106

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

21845241

Citation

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.

Results Reference

result

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

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