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Recruiting NCT07019428

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

No phase Interventional Free Gingival Graft Soft Tissue Augmentation Around Dental Implants Inadequate Keratinized Tissue Around Dental Implants

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Free gingival graft stabilized by Titanium fixation tacs, Free gingival graft stabilized by sutures.
Who it may be relevant to
Registry conditions: Free Gingival Graft, Soft Tissue Augmentation Around Dental Implants, Inadequate Keratinized Tissue Around Dental Implants. Basic parameters: 18 years — 40 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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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

Overview

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.

Interventions

  • 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

Primary outcome measures

  • Width of keratinized gingiva [Time frame: 6-month]
Secondary outcome measures (1)
  • Surgery time [Time frame: Perioperative]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Egypt · 1 center
  • Faculty of Dentistry, Cairo University — Cairo

Identifiers

NCT: NCT07019428 · TacFGG

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗