Augmentation of Peri-implant Keratinized Mucosa Using a Combination of Free Gingival Graft Strip … (NCT07346391) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Augmentation of Peri-implant Keratinized Mucosa Using a Combination of Free Gingival Graft Strip With Platelet-Rich Fibrin
Vietnam22 participantsStarted 2025-12-24
Plain-language summary
This clinical trial aims to evaluate the clinical effectiveness of combining a strip free gingival graft (sFGG) with Platelet-Rich Fibrin (PRF) for increasing keratinized mucosa around dental implants. The study compares this combined technique with the conventional free gingival graft (FGG) method through three primary objectives:
1. comparing the increase in keratinized mucosal height at immediate post-op, 1, 3, and 6 months;
2. assessing post-operative pain levels at 1, 3, 7, and 14 days;
3. evaluating soft tissue aesthetic outcomes at 4 and 6 months post-surgery.
Who can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients meeting the following criteria are eligible for the study:
* Prosthetic Phase: Patients scheduled for the prosthetic phase of dental implant treatment.
* Keratinized Mucosa: Keratinized mucosa height (buccal or lingual) of less than 2 mm around the implant.
* Systemic Health: Systemic health status classified as ASA I or II according to the American Society of Anesthesiologists classification.
* Oral Hygiene: Good oral hygiene, defined by a mean full-mouth plaque index (PlI) of ≤ 1.
Exclusion Criteria:
* Patients meeting any of the following criteria will be excluded from the study:
* Systemic Conditions: Presence of systemic diseases or use of medications known to affect the oral mucosa or gingival health.
* Periodontal Health: Untreated periodontal disease and/or peri-implant diseases.
* Surgical History: History of mucogingival surgery at the intended surgical site.
* Pregnancy/Lactation: Pregnant or breastfeeding women.
* Oral Hygiene: Poor oral hygiene, defined by a mean full-mouth plaque index (PlI) \> 1.
* Smoking: Current smokers.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Assessment of the increase in peri-implant keratinized mucosa width
Timeframe: 1, 3, 6 months
2
Soft tissue esthetics assessed by the modified Pink Esthetic Score (PES)
Timeframe: 4 months and 6 months post-operatively
3
Post-operative pain intensity measured by Visual Analog Scale (VAS)