Ridge Augmentation Clinical Trial
Official title:
Evaluation of Free Gingival Graft Timing in Staged Guided Bone Regeneration: A Randomized Controlled Trial
This clinical trial aims to compare and evaluate the clinical outcomes between two distinct treatment sequences: free gingival graft surgery preceding guided bone regeneration and guided bone regeneration followed by free gingival graft.
| Status | Not yet recruiting |
| Enrollment | 30 |
| Est. completion date | July 2027 |
| Est. primary completion date | July 2026 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | Unversity of Alabama at Birmingham, School of Dentistry | Birmingham | Alabama |
| Lead Sponsor | Collaborator |
|---|---|
| University of Alabama at Birmingham |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Volumetric outcome assessment | The volumetric outcomes of interest will be volume change in mm3 (Vol) and the mean distance between the surface/mean thickness of the reconstructed volume in mm. | Baseline to 12 months | |
| Primary | Buccal soft tissue profile | The assessment involves measuring the profile of the buccal soft tissue from the implant shoulder. | Baseline to 12 months |