RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

Acellular Collagen Matrix (Mucograft) As a Tool to Obtain Wound Closure Following GBR Procedures

Quick Facts

Study Start:2023-04-13
Study Completion:2025-06-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06871735

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:21 Years to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Have a missing tooth or teeth which are planned to be replaced with an implant
  2. * Need for guided bone regeneration procedure to increase the bone available for implant placement
  3. * Systemically healthy with no contraindications for bone grafting and/or implant surgery
  4. * No chronic sinus problems
  5. * Non-smoker
  6. * No need for removable temporary restorations during wound healing.
  1. * Patients that have sufficient bone volume to perform implant placement through conventional drilling protocol without any pre-implant GBR procedure
  2. * Indications for pre-implant/pre-GBR soft tissue grafting procedure to increase existing soft tissue contours
  3. * The need to wear a removable temporary restoration during healing

Contacts and Locations

Study Contact

Binnaz Leblebicioglu, DDS, MS, PhD
CONTACT
614-292-0371
leblebicioglu.1@osu.edu
Francesca Racca, DMD
CONTACT
(614) 292-0371
racca.2@osu.edu

Study Locations (Sites)

The Ohio State University Graduate Periodontics Clinic
Columbus, Ohio, 43210
United States

Collaborators and Investigators

Sponsor: Ohio State University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-04-13
Study Completion Date2025-06-30

Study Record Updates

Study Start Date2023-04-13
Study Completion Date2025-06-30

Terms related to this study

Keywords Provided by Researchers

  • GBR
  • Bone graft
  • dental implant

Additional Relevant MeSH Terms

  • Bone Graft