NCT07019428

Clinical Evaluation of a Modified Technique for Free Gingival Graft Stabilization Using Titanium Fixation Tacs Around Implants Versus Conventional Suturing Technique

Clinical Evaluation of a Modified Technique for Free Gingival Graft Stabilization Using Titanium Fixation Tacs Around Implants Versus Conventional Suturing Technique: A Randomized Controlled Clinical Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 26 (estimated)
• Sponsor: Cairo University · Academic / Other
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

Summary

The aim of this randomized, controlled, parallel-grouped, clinical trial is to evaluate the width of keratinized gingiva after free gingival graft stabilized by titanium fixation tacs compared to traditional suturing. Research question: In patients with inadequate keratinized gingiva undergoing soft tissue augmentation by free gingival graft , will graft stabilization using Titanium fixation tacs affect the amount of keratinized tissue gain compared to graft stabilization using sutures ?

Detailed description

Free gingival graft obtained from the palate, usually replaces missing or lost keratinized tissue. Although it represents the gold standard, its success relies on providing intimate and atraumatic stabilization, as maintaining the plasmatic circulation is crucial for graft healing and perfusion, considering that judging the success of free gingival graftis based on the extent of the postoperative healing contraction and the quality of graft adherence to the underlying periosteum. Suturing can be time consuming and sometimes fail to achieve a positive result. Also it was reported that for every one-minute increase of the gingival augmentation procedure time, there is a 4% likely increase for pain and a 3% for swelling. However, by using fixation tacs the surgical time can be significantly reduced and the procedure can be less technique sensitive.

Conditions

• Free Gingival Graft
• Soft Tissue Augmentation Around Dental Implants
• Inadequate Keratinized Tissue Around Dental Implants

Interventions

Type	Name	Description
PROCEDURE	Free gingival graft stabilized by Titanium fixation tacs	Free gingival graft stabilized by Titanium fixation tacs , in patients with inadequate keratinized gingiva
PROCEDURE	Free gingival graft stabilized by sutures	Free gingival graft stabilized by sutures , in patients with inadequate keratinized gingiva

Timeline

• Start date: 2024-11-02
• Primary completion: 2025-12-01
• Completion: 2026-02-01
• First posted: 2025-06-13
• Last updated: 2025-06-13

Locations

1 site across 1 country: Egypt