Evaluation of Free Gingival Graft Timing
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: FGG Before GBR, FGG after GBR.
- Who it may be relevant to
- Registry conditions: Ridge Augmentation, Alveolar Mucosa. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Evaluation of Free Gingival Graft Timing in Staged Guided Bone Regeneration: A Randomized Controlled Trial
Overview
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.
Detailed description
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. The primary objective is to assess the influence of the tissue graft timing on the outcomes of the guided bone regeneration. The secondary goal is to compare the complications that may arise following the two procedures before implant placement.
Interventions
- Procedure FGG Before GBR
Free Gingival Graft before the guided bone regeneration, - Procedure FGG after GBR
Free Gingival Graft after the guided bone regeneration,
Primary outcome measures
- Volumetric outcome assessment [Time frame: Baseline to 12 months]
- Buccal soft tissue profile [Time frame: Baseline to 12 months]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Unversity of Alabama at Birmingham, School of Dentistry — Birmingham
Identifiers
NCT: NCT06294587 · IRB-300012407 · UAB-SOD