Influence of Hyaluronic Acid in the Healing of Palatal Donor Sites During Free Gingival Graft Pro… (NCT07458685) | Clinical Trial Compass
CompletedNot Applicable
Influence of Hyaluronic Acid in the Healing of Palatal Donor Sites During Free Gingival Graft Procedures
Italy20 participantsStarted 2022-09-05
Plain-language summary
The goal of this study is to evaluate the use of a gel containing cross-linked hyaluronic acid (xHyA) at the palatal donor site following soft tissue harvesting procedures. The main questions it aims to answer are: 1) Does the use of xHyA improve post-operative patient morbidity?; 2) Does the use of xHyA improve palatal donor site healing? Researchers will compare xHyA topically applied at the palatal donor site to a negative control to see if xHyA works to minimize participants' morbidity and improve clinical healing.
Participants will be equally distributed into two groups, half of them receiving xHyA. Participants will fill a visual analogue scale for subjective analyses during the first 2 post-operative weeks and will visit the dental clinic at 3, 7, 14 and 60 post-operative days for checkups and clinical examinations.
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:
* Good general health (ASA 1 or 2)
* No local contraindications to implant surgery procedures (mucosal inflammation, active periodontal disease, erosive mucosal conditions, bone lesions, history of local radiation therapy and bruxism along with inadequate oral hygiene or lack of motivation for home care)
* Presence of two adjacent implants either submerged or prosthetically loaded
* Premolar and/or molar sectors of either the mandible or the maxilla
* Presence of \< 2 mm of keratinized mucosa width at the buccal aspect of the said adjacent implants
Exclusion Criteria:
* Smokers (\> 10 cigarettes/day)
* Subjects with known allergies to penicillin or collagen
* Poor oral hygiene
* Uncontrolled systemic pahologies
* Active periodontal infection
* No medical history of head and neck radiation therapy
* No medical history of antiresorptive agents or steroids therapies
* Pregnant or lactating women
* Physical or mental disabilities affecting oral hygiene
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
Subjective post-operative morbidity evaluation with a visual analogue scale during the first 2 post-operative weeks