Evaluation of Free Gingival Graft Timing

The University of Alabama at Birmingham

Status: Enrolling

Conditions: Alveolar Mucosa; Ridge Augmentation

Treatments: Procedure: FGG Before GBR; Procedure: FGG after GBR

Study type: Interventional

Funder types: Other

Identifiers

NCT06294587

UAB-SOD (Other Identifier)

IRB-300012407

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

FGG before GBR

Experimental group

Description:

Free Gingival Graft(FGG) before the guided bone regeneration(GBR)

Treatment:

Procedure: FGG Before GBR

FGG after GBR

Experimental group

Description:

Free Gingival Graft(FGG) after the guided bone regeneration(GBR)

Treatment:

Procedure: FGG after GBR