Clinical trial NCT06294587: Evaluation of Free Gingival Graft Timing
Official title: Evaluation of Free Gingival Graft Timing in Staged Guided Bone Regeneration: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Ridge Augmentation
Alveolar Mucosa
Keywords: Ridge Augmentation
Attached mucosa
Dental implants
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2024-03-05
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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 (\&gt; 10 cigarettes) who quit \&lt; 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

Primary outcomes:
measure: Volumetric outcome assessment
timeFrame: Baseline to 12 months
measure: Buccal soft tissue profile
timeFrame: Baseline to 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Unversity of Alabama at Birmingham, School of Dentistry
state: Alabama
Study officials:
References: