NCT06871735 Acellular Collagen Matrix as a Tool to Obtain Wound Closure Following a Guided Bone Regeneration Procedure
| NCT ID | NCT06871735 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Ohio State University |
| Condition | Bone Graft |
| Study Type | OBSERVATIONAL |
| Enrollment | 30 participants |
| Start Date | 2023-04-13 |
| Primary Completion | 2026-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 30 participants in total. It began in 2023-04-13 with a primary completion date of 2026-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06871735 clinical trial?
This trial is open to participants of all sexes, aged 21 Years or older, up to 75 Years, studying Bone Graft. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06871735 currently recruiting?
Yes, NCT06871735 is actively recruiting participants. Contact the research team at leblebicioglu.1@osu.edu for enrollment information.
Where is the NCT06871735 trial being conducted?
This trial is being conducted at Columbus, United States.
Who is sponsoring the NCT06871735 clinical trial?
NCT06871735 is sponsored by Ohio State University. The trial plans to enroll 30 participants.