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

March 1, 2016 updated by: William Giannobile

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Ann Arbor, Michigan, United States, 48106
        • Michigan Center for Oral Health Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Placing OSSIX-Plus in Extraction Site
Placement of OSSIX-Plus, a resorbable collagen membrane, and the promotion of bone healing following exodontia.
Device: OSSIX-Plus
resorbable collagen membrane

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Bone Gain or Loss in Millimeters (Buccopalatal)
Time Frame: From Baseline to 12 weeks
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)
Time Frame: From Baseline to 12 weeks
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)
Time Frame: From Baseline to 12 weeks
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
Time Frame: From Baseline to 12 weeks
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
Time Frame: From Baseline to 12 weeks
Percentage of new bone formation of the alveolar bone core biopsies.
From Baseline to 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

William Giannobile

Collaborators

Johnson & Johnson
OraPharma

Investigators

  • Principal Investigator: William V Giannobile, DDS, DMedSc, PROFESSOR

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2008

Primary Completion (ACTUAL)

March 1, 2009

Study Completion (ACTUAL)

March 1, 2009

Study Registration Dates

First Submitted

March 14, 2008

First Submitted That Met QC Criteria

March 14, 2008

First Posted (ESTIMATE)

March 20, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

March 31, 2016

Last Update Submitted That Met QC Criteria

March 1, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HUM00016574

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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