Evaluation of Free Gingival Graft Timing

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Ridge Augmentation; Alveolar Mucosa
• Intervention / Treatment: Procedure: FGG Before GBR; Procedure: FGG after GBR

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sarah Startley, DMD; Phone Number: 205-975-8711; Email: ss1971@uab.edu
• Study Contact Backup: Name: Hussein Basma, DDS, MS; Phone Number: 205-975-2888; Email: basma86@uab.edu

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294-0007
      • Unversity of Alabama at Birmingham, School of Dentistry
      • Contact: Sarah Startley, DMD; Phone Number: 205-975-8711; Email: ss1971@uab.edu
      • Contact: Hussein Basma, DDS, MS; Phone Number: 205-975-2888; Email: basma86@uab.edu
      • Principal Investigator: Hussein Basma, DDS, MS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: FGG before GBR; Free Gingival Graft(FGG) before the guided bone regeneration(GBR)	Procedure: FGG Before GBR; Free Gingival Graft before the guided bone regeneration,
Experimental: FGG after GBR; Free Gingival Graft(FGG) after the guided bone regeneration(GBR)	Procedure: FGG after GBR; Free Gingival Graft after the guided bone regeneration,

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Buccal soft tissue profile	The assessment involves measuring the profile of the buccal soft tissue from the implant shoulder.	Baseline to 12 months

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2027

Study Registration Dates

• First Submitted: February 28, 2024
• First Submitted That Met QC Criteria: February 28, 2024
• First Posted (Estimated): March 5, 2024

Study Record Updates

• Last Update Posted (Estimated): March 5, 2024
• Last Update Submitted That Met QC Criteria: February 28, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Dental implants; Ridge Augmentation; Attached mucosa
• Other Study ID Numbers: IRB-300012407

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No