Titanium fixation tacs versus sutures for securing free gingival grafts around dental implants
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
This test will see if using titanium fixation tacs to secure free gingival grafts in adults with inadequate keratinized gum around dental implants leads to more keratinized tissue gain than using sutures.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 26 (estimated) |
| Ages | 18 Years to 40 Years |
| Sex | All |
| Sponsor | Cairo University Academic / other |
| Locations | 1 site (Cairo) |
| Trial ID | NCT07019428 on ClinicalTrials.gov |
What this trial studies
This randomized, controlled, parallel-group trial enrolls eligible adults to receive a free gingival graft from the palate that is secured either with titanium fixation tacs or with conventional sutures. The primary outcome is the width of keratinized gingiva measured after healing using standardized clinical measurements at scheduled follow-up visits. Investigators hypothesize that tacs will reduce operative time and improve intimate graft stabilization, which may reduce healing contraction and improve tissue adherence. The single-center study is conducted at the Faculty of Dentistry, Cairo University with strict inclusion and exclusion criteria to select healthy non-smoking participants.
Who should consider this trial
Good fit: Healthy non-smoking adults aged 18–40 with less than 2 mm of keratinized gingiva around dental implants, good plaque control, no active periodontal disease, and no contraindicating medical conditions are ideal candidates.
Not a fit: Patients who smoke, have systemic disease, take blood thinners or drugs that cause gingival enlargement, are pregnant or lactating, undergoing orthodontic treatment, or have active periodontal disease are unlikely to qualify or benefit.
Why it matters
Potential benefit: If successful, using titanium tacs could shorten surgery time, improve graft stability, and result in greater keratinized tissue gain with potentially less postoperative discomfort.
How similar studies have performed: Fixation tacks and similar anchoring devices have been reported in mucogingival surgery with favorable case series, but randomized head-to-head evidence against sutures is limited.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Cairo
- Faculty of Dentistry, Cairo University — Cairo, Egypt (Recruiting)
Study contacts
- Principal investigator: Amr Zahran, Professor of Periodontology — Cairo University
- Study coordinator: Mohamed Atef Kamal Ibrahim, Bds
- Email: mohamed-kamal@dentistry.cu.edu.eg
- Phone: +2001121266030
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.