Actively Recruiting
Evaluation of Free Gingival Graft Timing in Staged Guided Bone Regeneration: A Randomized Controlled Trial
Led by University of Alabama at Birmingham · Updated on 2025-08-06
30
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This clinical trial investigates the timing of free gingival graft surgery in relation to guided bone regeneration. It aims to compare and evaluate clinical outcomes between two treatment sequences: free gingival graft surgery before guided bone regeneration and guided bone regeneration followed by free gingival graft. The study focuses on how the timing of the tissue graft affects the results of bone regeneration and examines potential complications before implant placement. Participants will be randomly assigned to one of two groups: one receiving a free gingival graft before guided bone regeneration, and the other receiving the graft after the bone regeneration. Both procedures are performed as part of staged treatments to prepare for dental implant placement. The study tracks these treatment sequences to understand their effects over a 12-month period. During the 12 months following treatment, researchers will assess the volumetric outcomes and the buccal soft tissue profile from baseline. Participants will undergo diagnostic and clinical evaluations before and after surgery, including bone sounding and CBCT scans to measure alveolar ridge width. The trial monitors oral hygiene and healing progress while recording any complications. Participants are expected to comply with all study procedures and follow-up visits throughout the study duration.
CONDITIONS
Brief Title
Evaluation of Free Gingival Graft Timing
Who Can Participate
Eligibility Criteria
You may qualify if you...
- At least 18 years old
- No uncontrolled medical conditions or medications affecting bone healing
- Good oral hygiene with full-mouth plaque score 25% or less
- Able to read and understand informed consent
- Need for implants to replace missing tooth/teeth in at least one quadrant
- Insufficient alveolar ridge width of 5 mm or less as confirmed by bone sounding and CBCT scan
- Willing and able to comply with pre- and post-operative evaluations
- Not pregnant or breastfeeding
You will not qualify if you...
- Active infectious diseases
- Liver or kidney dysfunction or failure
- Uncontrolled diabetes with HbA1c 8.5 or higher
- Active cancer treatment or radiotherapy within 12 months
- Taking medications that affect bone healing such as bisphosphonates or long-term anti-inflammatory drugs
- Metabolic bone diseases affecting bone healing like osteoporosis
- Pregnant or lactating women
- Current smokers of 10 or more cigarettes per day or recent former smokers who quit less than 10 years ago after heavy smoking
- Poor oral hygiene
- Vertical bone loss at the edentulous ridge
- History of periodontal disease
- Pregnant or breastfeeding (self-reported)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 12 months
Participants undergo free gingival graft surgery and guided bone regeneration in one of two sequences to evaluate the timing effect on treatment outcomes.
Multiple visits for surgical procedures and assessments over 12 months
Trial Site Locations
Total: 1 location
1
Unversity of Alabama at Birmingham, School of Dentistry
Birmingham, Alabama, United States, 35294-0007
Actively Recruiting
Research Team
H
Hussein Basma, DDS, MS
S
Sarah Startley, DMD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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