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

Not Applicable

Recruiting

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

• Registration Number: NCT07019428
• Lead Sponsor: Cairo University

Brief 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.

Study Timeline

• Study Start: 2024-11-02
• Study First Submitted: 2025-01-02
• Status Verified: 2025-05
• Study First Submitted QC: 2025-06-12
• Last Update Submitted: 2025-06-12
• Study First Posted: 2025-06-13
• Last Update Posted: 2025-06-13
• Primary Completion: 2025-12-01
• Study Completion: 2026-02-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 26

Inclusion Criteria

• Systemically healthy individuals of age ≥ 18 to 40 years with absence of active periodontal disease.
• Having inadequate width of keratinized gingiva (< 2 mm).
• No systemic disease according to Modified Cornell Medical Index health questionnaire
• Non-smoker.
• Full mouth plaque index (PI) and full-mouth bleeding on probing (BOP) score of ≤ 15%.
• No malocclusion, crowding, fillings, missing or supernumerary mandibular anterior teeth.
• No blood-borne conditions.

Exclusion Criteria

• Active orthodontic treatment.
• Previous periodontal surgery.
• Systemic disease.
• Use of blood thinners.
• Use of any drugs that might lead to gingival enlargement.
• Mucogingival stress, bruxism.
• Pregnancy or lactation.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Width of keratinized gingiva	6-month

Secondary Outcome Measures

Name	Time	Method
Surgery time	Perioperative	time spent from the beginning to the end of surgery

Trial Locations

Locations (1)

Faculty of Dentistry, Cairo University; 🇪🇬 Cairo, Egypt