Clinical trial NCT07019428: Clinical Evaluation of a Modified Technique for Free Gingival Graft Stabilization Using Titanium Fixation Tacs Around Implants Versus Conventional Suturing Technique
Official 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Free Gingival Graft
Soft Tissue Augmentation Around Dental Implants
Inadequate Keratinized Tissue Around Dental Implants
Keywords: Free gingival graft
Titanium tacks
Keratinized tissue
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2025-06-13
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Width of keratinized gingiva
timeFrame: 6-month
Secondary outcomes:
measure: Surgery time
timeFrame: Perioperative
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Dentistry, Cairo University
Study officials:
affiliation: Cairo University
name: Amr Zahran, Professor of Periodontology
role: PRINCIPAL_INVESTIGATOR
affiliation: Cairo University
name: Manar El Zanaty, lecturer of Periodontology
role: PRINCIPAL_INVESTIGATOR
References: