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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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07019428
Enrollment
26
Registered
2025-06-13
Start date
2024-11-02
Completion date
2026-02-01
Last updated
2025-06-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Free gingival graft, Titanium tacks, Keratinized tissue

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.

Interventions

PROCEDUREFree gingival graft stabilized by Titanium fixation tacs

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

PROCEDUREFree gingival graft stabilized by sutures

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

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frame
Width of keratinized gingiva6-month

Secondary

MeasureTime frameDescription
Surgery timePerioperativetime spent from the beginning to the end of surgery

Countries

Egypt

Contacts

Primary ContactMohamed Atef Kamal Ibrahim, Bds
mohamed-kamal@dentistry.cu.edu.eg+2001121266030

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026