Acellular Collagen Matrix as a Tool to Obtain Wound Closure Following a Guided Bone Regeneration Procedure
NCT ID: NCT06871735
Last Updated: 2026-01-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
30 participants
OBSERVATIONAL
2023-04-13
2026-04-30
Brief Summary
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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.
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Detailed Description
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Surgical site will be anesthetized with routine local anesthesia protocol. Crestal incisions followed by sulcular and/or vertical incisions will be performed, and full thickness flap elevation will be performed to reach alveolar bone. Recipient site will be prepared through decortication of the bone surface, trimming, and adapting the cross-linked collagen membrane. Allograft alone or mixed with autograft and/or xenograft will be placed into defect based on case specific indications. Wound closure will be accomplished by suturing the edges of the wound. In some cases, conventional method of wound closure through periosteal releasing incision and coronally positioned flap is not possible due to anatomical limitations. Although not ideal, barrier membrane is left exposed during healing for these cases. We intend to cover these exposed areas with ACM (acellular matrix) as described in the literature to determine whether this approach differentially affects outcomes. Standard post-operative care protocols will be followed including post-operative prescriptions for antibiotics, analgesics and antiseptic mouth rinse.
This clinical study aims to compare these two techniques by evaluating the clinical outcomes of early wound healing. The working hypothesis is that the use of acellular collagen matrix prevents shallow vestibulum formation and secondary surgeries to overcome with soft tissue deficiencies compared to conventional surgical approach.
Research related procedures: - Radiographic/CBCT and clinical measurements and recording of the alveolar ridge prior to surgery (these are obtained as part of standard of care to evaluate the site during treatment planning for bone grafting then, later, for implant placement. We will be recording additional volumetric measurements by using these tools \[same radiographic/CBCT documents\] as part of the study). - Clinical measurements and recording of the alveolar ridge dimensions after flap elevation and after ridge augmentation. - Details of the surgery including bone quality (reported by surgeon), presence of buccal dehiscence/fenestration, the need of additional bone grafting of the ridge, the indications for barrier membrane placement. - Soft and hard tissue sampling at implant placement surgery (these tissues are generally discarded while opening space for implant fixture. We intend to keep them to study the quality of the regenerated tissues). - Questions to evaluate patient experience (pain and discomfort during and after surgery).
Observation period will be up to 4-6 months (until implant placement surgery) and wound healing will be evaluated through clinical parameters (8-10 days, 6-8 weeks and 4-6 months), implant stability (initial and 4-6 months) and CBCT (pre-surgical and 4-6 months ridge dimensions). These post-operative observation periods are a part of standard protocol. Each appointment may be 40 minutes longer than routine appointment due to research related measurements.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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With acellular matrix
Participants who are having the GBR procedure done with the use of the acellular matrix material to cover the graft/wound
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
Participants who are having the GBR procedure done by having the wound closed without the acellular material
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
21 Years
75 Years
ALL
No
Sponsors
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Ohio State University
OTHER
Responsible Party
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Binnaz Leblebicioglu
Professor
Locations
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The Ohio State University Graduate Periodontics Clinic
Columbus, Ohio, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2023H0107
Identifier Type: -
Identifier Source: org_study_id
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