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NCT Number: NCT07019428

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

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 ?

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Key information

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry, Cairo University

Cairo, 11511, Egypt

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Free gingival graft stabilized by Titanium fixation tacs

Procedure

Free gingival graft stabilized by Titanium fixation tacs , in patients with inadequate keratinized gingiva

Free gingival graft stabilized by sutures

Procedure

Free gingival graft stabilized by sutures , in patients with inadequate keratinized gingiva

Primary outcomes

  1. Width of keratinized gingiva

    Time frame: 6-month

Secondary outcomes

  1. Surgery time

    Time frame: Perioperative

    time spent from the beginning to the end of surgery

Study contacts

Contact information is provided by the study sponsor or research team.

Mohamed Atef Kamal Ibrahim, Bds

CONTACT

[email protected]

+2001121266030

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Jun 13, 2025
Registry last updated
Jun 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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