Recruiting

Acellular Collagen Matrix

Sponsor:

Ohio State University

Code:

NCT06871735

Conditions

Bone Graft

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Not accepted

Interventions

Acellular matrix

Surgical closure

Study Details

Brief summary:

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.

Conditions

Bone Graft

Study ID

NCT06871735

Start date

Apr 13, 2023

Status verified date

Feb, 2026

Completion date

Oct, 2026

Anticipated

Primary completion date

Oct, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Have a missing tooth or teeth which are planned to be replaced with an implant
  • Need for guided bone regeneration procedure to increase the bone available for implant placement
  • Systemically healthy with no contraindications for bone grafting and/or implant surgery
  • No chronic sinus problems
  • Non-smoker
  • No need for removable temporary restorations during wound healing.

Exclusion Criteria:

  • Patients that have sufficient bone volume to perform implant placement through conventional drilling protocol without any pre-implant GBR procedure
  • Indications for pre-implant/pre-GBR soft tissue grafting procedure to increase existing soft tissue contours
  • The need to wear a removable temporary restoration during healing

Study Design

Enrollment

30 participants

Anticipated

Interventions and Outcome Measures

Arms

With acellular matrix

Participants who are having the GBR procedure done with the use of the acellular matrix material to cover the graft/wound

Surgical closure

Participants who are having the GBR procedure done by having the wound closed without the acellular material

Interventions

Acellular matrix

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

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.

Primary outcome measure

  • Healing Score Index 8-10 days [ Time Frame: 8-10 days following the surgical procedure ]
  • Healing Score Index 6-8 weeks [ Time Frame: 6-8 weeks following the surgical procedure ]
  • Wound Healing 8-10 days [ Time Frame: 8-10 days following the surgical procedure ]
  • Wound Healing 6-8 weeks [ Time Frame: 6-8 weeks following the surgical procedure ]

Central Contacts and Locations

Central contacts

Binnaz Leblebicioglu, DDS, MS, PhD

614-292-0371leblebicioglu.1@osu.edu

Francesca Racca, DMD

(614) 292-0371racca.2@osu.edu

Locations

The Ohio State University Graduate Periodontics Clinic

Recruiting

Columbus, Ohio, United States, 43210

Contacts

Binnaz Leblebicioglu, DDS, MS, PhD

614-292-0371leblebicioglu.1@osu.edu

More Information

Sponsor

Ohio State University

Last update posted

Feb 13, 2026

Last verified

Feb, 2026

Keywords

  • GBR
  • Bone graft
  • dental implant

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ohio State University on 2026-02-13.