Acellular Collagen Matrix as a Tool to Obtain Wound Closure Following a Guided Bone Regeneration Procedure

Part of paid clinical trials in Columbus, Ohio.

Sponsor
Ohio State University
Study ID
NCT06871735
Status
Recruiting
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Conditions

  • Bone Graft

Eligibility Criteria

Sex
ALL
Age
21 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Acellular matrix — PROCEDURE
    Wound closure is obtained by use of acellular matrix material placed over the exposed barrier membrane. The procedure itself is not part of the research study, nor is the decision to use this procedure, but it is the condition of interest to the research.
  • Surgical closure — PROCEDURE
    Wound from the graft is surgically closed, with no use of the acellular matrix. The procedure itself is not part of the research study, nor is the decision to use this procedure, but it is the condition of interest to the research.

Study Details

Guided bone regeneration (GBR) is a procedure used to increase the amount of bone volume in the jaw before placing a dental implant. It is needed when a lot of bone has been lost around the spot where a tooth has been lost or extracted. An incision is made, bone grafting material is placed in that spot, there is a membrane put over it as a barrier, then gum tissue has to be pulled back over it. Usually, this is enough to cover the whole wound, but sometimes the barrier membrane can't be covered with tissue the whole way without too much pulling, and the barrier membrane is still exposed. In that case, one thing that can be done is to place another material, an acellular collagen matrix, over the barrier membrane and secure it there. This material has been shown to help with the healing in these cases. Participants in this study will be clinic patients who have been determined to need a GBR procedure. Participants will get the GBR. If the barrier membrane is still exposed, then the acellular matrix material will be placed. This study will compare the healing outcomes and the success of the GBR depending on whether the acellular matrix material was used. The procedure itself is not part of the study. The only people in the study are patients who are already planning to have this procedure done as part of their dental care. It is important to note that the research study will not affect the care that the patient is given, or whether or not the acellular matrix material is used. That will be decided by the dental surgeon who is treating them, based on their clinical judgement. The research study will only observe and compare the outcomes. For the study, participants will have some additional clinical measurements made, besides the ones that are done as part of the follow-up care, and will be asked questions about their experience.

Key Dates

Start date
Apr 13, 2023
Status verified
Feb 2026
Primary completion
Oct 31, 2026
Completion
Oct 31, 2026

Study Design

Enrollment
30 participants (estimated)

Arms

  • Arm: With acellular matrix
    Participants who are having the GBR procedure done with the use of the acellular matrix material to cover the graft/wound
  • Arm: Surgical closure
    Participants who are having the GBR procedure done by having the wound closed without the acellular material

Primary Outcome Measure

Healing Score Index 8-10 days [ Time Frame: 8-10 days following the surgical procedure ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The Ohio State University Graduate Periodontics ClinicColumbusOhio43210
Binnaz Leblebicioglu, DDS, MS, PhD
[email protected]
614-292-0371

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By research site
The Ohio State University Graduate Periodontics Clinic· Columbus, OH

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