Comparing timing of gum grafts and bone regeneration for dental implants
Evaluation of Free Gingival Graft Timing in Staged Guided Bone Regeneration: A Randomized Controlled Trial
This study is testing whether doing gum surgery before or after bone treatment helps dental implants heal better and have fewer problems.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Alabama at Birmingham Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Birmingham, Alabama) |
| Trial ID | NCT06294587 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the clinical outcomes of two different treatment sequences for dental implants: performing free gingival graft (FGG) surgery before guided bone regeneration (GBR) versus performing GBR followed by FGG. The primary objective is to determine how the timing of the tissue graft affects the success of the bone regeneration process. Additionally, the study aims to assess any complications that may arise from either treatment sequence prior to implant placement. Participants will be monitored for their healing and overall outcomes following the procedures.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who require dental implants and have insufficient alveolar ridge width for placement.
Not a fit: Patients with uncontrolled medical conditions, active infections, or those undergoing cancer treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the success rates of dental implants by optimizing the timing of gum grafts and bone regeneration.
How similar studies have performed: While this approach has been explored in various contexts, the specific timing comparison of FGG and GBR in this manner is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * • At least 18 years old * No uncontrolled medical conditions or medications that will affect their bone healing. * Good oral hygiene is defined as a full-mouth plaque score ≤25%11. * Must be able to read and understand the informed consent document. * Has a need for implants to replace missing tooth/teeth in at least 1 quadrant of the mouth. * Insufficient alveolar ridge width for endosseous implant placement, defined as 5 mm or less, as determined by bone sounding and CBCT scan. * The patient and/or guardian is willing and able to comply with pre-operative and post-operative diagnostic and clinical evaluations required. * The patient is not pregnant or breastfeeding. Exclusion Criteria: * Active infectious diseases. * Liver or kidney dysfunction/failure. * Uncontrolled diabetes (HbA1c ≥ 8.5). * Active cancer treatment - such as active chemotherapy radiation therapy, or radiotherapy performed within ≤12 months from the procedure. * Taking medications that will affect their bone healing (for example, bisphosphonates and long-term anti-inflammatory medications). * Metabolic bone diseases that affect bone healing such as osteoporosis. * Pregnant or lactating women (self-reported). * Current tobacco and Marijuana smokers have 10 or more cigarettes per day, and former smokers (\> 10 cigarettes) who quit \< 10 ago (self-reported). * Poor oral hygiene. * Vertical loss of bone at the edentulous ridge. * History of periodontal disease. * The patient is pregnant or breastfeeding
Where this trial is running
Birmingham, Alabama
- Unversity of Alabama at Birmingham, School of Dentistry — Birmingham, Alabama, United States (Recruiting)
Study contacts
- Study coordinator: Hussein Basma, DDS, MS
- Email: basma86@uab.edu
- Phone: 205-975-2888
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.