Use of a Custom-Made Acrylic Palatal Stent to Minimize Donor Site Morbidity After Suture-Free Epi… (NCT07501754) | Clinical Trial Compass
CompletedNot Applicable
Use of a Custom-Made Acrylic Palatal Stent to Minimize Donor Site Morbidity After Suture-Free Epithelialized Gingival Graft Harvesting: A Randomized Clinical Trial
Italy44 participantsStarted 2025-01-07
Plain-language summary
Epithelialized gingival graft (EGG) harvesting from the palate is associated with postoperative morbidity, including pain and bleeding, due to healing by secondary intention. The effectiveness of palatal stents in reducing donor-site morbidity, particularly in suture-free techniques, remains unclear.
This randomized controlled clinical trial evaluates the effect of a custom-made acrylic palatal stent (APS) compared with no stent on postoperative outcomes following EGG harvesting.
The primary outcome is postoperative pain assessed using a visual analog scale (VAS). Secondary outcomes include other patient-reported measures, clinician-reported healing, and exploratory assessments of tissue healing.
Who can participate
Age range
18 Years
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:
* Adults ≥18 years of age
* Patients requiring periodontal plastic surgery involving epithelialized gingival graft (EGG) harvesting from the palate
* Indications including keratinized tissue augmentation, soft tissue thickness augmentation, or root coverage procedures
* Adequate palatal tissue thickness to allow graft harvesting (≥2 mm)
* Full-mouth plaque score (FMPS) and full-mouth bleeding score (FMBS) ≤20%
* Ability to understand and complete patient-reported outcome questionnaires
* Signed informed consent
* Willingness to comply with study procedures and follow-up visits
Exclusion Criteria:
* compromised general health contraindicating the procedures (ASA III-VI)
* heavy smokers (≥ 10 cigarettes/day),
* systemic diseases or medications affecting treatment outcomes,
* known allergies or hypersensitivity to ibuprofen.
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.