NCT06871735 · Ohio State University
Acellular Collagen Matrix as a Tool to Obtain Wound Closure Following a Guided Bone Regeneration Procedure
What this study is about
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.
View original scientific description
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.
Interventions
PROCEDURE
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.
PROCEDURE
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 measures
Healing Score Index 8-10 days
Time frame: 8-10 days following the surgical procedure
Healing Score Index (Pippi modification of Landry wound healing index): * presence/absence of redness; * presence/absence of granulation tissue; * presence/absence of suppuration; * presence/absence of swelling; * degree of tissue epithelialization (partial/complete); * presence/absence of bleeding; * presence/absence of pain on palpation. * presence/absence of plaque (% of plaque positive surfaces) At first PO appointment
Healing Score Index 6-8 weeks
Time frame: 6-8 weeks following the surgical procedure
Healing Score Index (Pippi modification of Landry wound healing index): * presence/absence of redness; * presence/absence of granulation tissue; * presence/absence of suppuration; * presence/absence of swelling; * degree of tissue epithelialization (partial/complete); * presence/absence of bleeding; * presence/absence of pain on palpation. * presence/absence of plaque (% of plaque positive surfaces) At second PO appointment
Wound Healing 8-10 days
Time frame: 8-10 days following the surgical procedure
Clinical wound healing will be scored as yes or no for each of the following wound healing parameters: * Mature wound healing, defined as complete wound closure without other significant findings. * Erythema, defined as increased redness compared to adjacent non-operated sites * Bleeding, defined as presence of spontaneous bleeding at the wound site * Graft mobility, defined as loose subgingival bone graft material evaluated by gentle palpation using a UNC-15 probe (if grafting was done during surgery) * Suppuration, defined as presence of pus or discharge at the wound site * Necrosis, defined as any visual soft and/or hard tissue necrosis at the wound site * Clinical wound exposure and closure and hydrogen peroxide test(+/-) At first PO appointment
Wound Healing 6-8 weeks
Time frame: 6-8 weeks following the surgical procedure
Clinical wound healing will be scored as yes or no for each of the following wound healing parameters: * Mature wound healing, defined as complete wound closure without other significant findings. * Erythema, defined as increased redness compared to adjacent non-operated sites * Bleeding, defined as presence of spontaneous bleeding at the wound site * Graft mobility, defined as loose subgingival bone graft material evaluated by gentle palpation using a UNC-15 probe (if grafting was done during surgery) * Suppuration, defined as presence of pus or discharge at the wound site * Necrosis, defined as any visual soft and/or hard tissue necrosis at the wound site * Clinical wound exposure and closure and hydrogen peroxide test(+/-) At second PO appointment
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- 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
Where
- Columbus, Ohio
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 13, 2026 · Source of record for eligibility and locations