Clinical Evaluation of a Modified Technique for Free Gingival Graft Stabilization Using Titanium Fixation Tacs Around Implants Versus Conventional Suturing Technique
1 other identifier
interventional
26
1 country
1
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 ?
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Nov 2024
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 2, 2024
CompletedFirst Submitted
Initial submission to the registry
January 2, 2025
CompletedFirst Posted
Study publicly available on registry
June 13, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2026
CompletedJune 13, 2025
May 1, 2025
1.1 years
January 2, 2025
June 12, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Width of keratinized gingiva
6-month
Secondary Outcomes (1)
Surgery time
Perioperative
Study Arms (2)
Free gingival graft stabilized by sutures
ACTIVE COMPARATORFree gingival graft stabilized by by Titanium fixation tacs
EXPERIMENTALInterventions
Free gingival graft stabilized by Titanium fixation tacs , in patients with inadequate keratinized gingiva
Free gingival graft stabilized by sutures , in patients with inadequate keratinized gingiva
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
Study Sites (1)
Faculty of Dentistry, Cairo University
Cairo, 11511, Egypt
Study Officials
- PRINCIPAL INVESTIGATOR
Amr Zahran, Professor of Periodontology
Cairo University
- PRINCIPAL INVESTIGATOR
Manar El Zanaty, lecturer of Periodontology
Cairo University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
January 2, 2025
First Posted
June 13, 2025
Study Start
November 2, 2024
Primary Completion
December 1, 2025
Study Completion
February 1, 2026
Last Updated
June 13, 2025
Record last verified: 2025-05