Palatal Mucosa Wound Healing Following Antimicrobial Gel Application (NCT06737653) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Palatal Mucosa Wound Healing Following Antimicrobial Gel Application
Italy13 participantsStarted 2024-12-22
Plain-language summary
The present study will be a prospective, randomized, triple-blind, split-mouth, clinical trial.
The study timeline will be include seven total visits. After a screening/study enrolment visit, a wounding surgery visit (Day 0) will be schedule. On Day 0, one standardized wound will be created on each side of the palate (DFGG required for root coverage procedure). Each side of the palate randomly received either antimicrobial gel (treatment group) or placebo (control group) at day 0, 1 and 3.
The patients, an experienced periodontist who performed the surgical procedures and the clinical examiners will be blinded to treatment allocation.
Clinical healing response and patient related outcome measures (PROMs) will be evaluated on postoperative Day 1, 3, 7, 14, 21 and 30.
Who can participate
Age range
18 Years – 38 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:
* aged 18 to 38 years (age limits based on evidence of delayed wound healing in older adults, Engeland et al., 2006);
* full-mouth plaque score and full-mouth bleeding score ≤ 15% at study entry;
* adequate anteroposterior arch length for required wound size and spacing;
* able to easily tolerate maxillary impression making and use of palatal template;
* patients required at least two root coverages procedures in one tooth in different sextants with DFGG;
* palate with no pathological or morphological alteration.
Exclusion Criteria:
* untreated periodontitis;
* previous surgery on the palate;
* history of poor wound healing;
* systemic diseases and/or coagulations disorders;
* pregnant or lactating;
* smoking or marijuana use (non-smoker status verified by exhaled air carbon monoxide as previously described);
* medications affecting periodontal status (e.g. phenytoin, calcium channel blockers and cyclosporine);
* therapy with anticoagulants, nonsteroidal anti-inflammatory drugs, corticosteroids, or any drug interfering with the healing process during the previous six months;
* contraindication to receiving any of the active components of the antimicrobial gel.
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
Color Match (CM)
Timeframe: CM will be evaluated on post-operative days 1, 3, 7, 14, 21 and 30