Alternative Gingival De-Epithelialization Techniques (NCT05947305) | Clinical Trial Compass
By InvitationNot Applicable
Alternative Gingival De-Epithelialization Techniques
United States48 participantsStarted 2024-04-04
Plain-language summary
The goal of this clinical trial is to compare different de-epithelialization methods in patients undergoing soft tissue augmentation surgery. The main questions it aims to answer are:
• Which technique is superior for de-epithelialization in terms of remaining epithelium, wound healing of the donor site, and clinical outcomes?
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:
* American Society of Anesthesiologists (ASA) Physical Status Classification I or II
* Subjects undergoing periodontal surgical procedures that involve harvesting of soft tissue samples, who have a treatment plan including the use or removal of keratinized mucosa or subepithelial connective tissue that will not require additional anesthesia for sample collection
* Adequate physical and mental health to undergo routine dental treatment
* Ability and willingness to follow instructions related to the study procedures
Exclusion Criteria:
* Poorly controlled diabetes, defined as HbA1c \>/= 7.0
* Autoimmune or inflammatory conditions such as systemic lupus erythematous, rheumatoid arthritis.
* Pregnant women or nursing mothers, or unsure of pregnancy status (self-reported)
* Severe hematologic disorders, such as leukemia or hemophilia
* Subjects on anticoagulant or antiplatelet therapy
* Local or systemic infection that may interfere with healing
* Hepatic or renal diseases
* Currently under cancer treatment or within 18 months from completion of radio- or chemotherapy
* History of antibiotic or immunosuppressant use in the last 3 months
* Subjects on concomitant drug therapy for systemic conditions that may affect outcomes of the study
* Current smokers (CDC definition): heavy smokers: subjects who have smoked \>10 cigarettes per day within 6 months of study onset, and have smoked \>100 cigarettes in their lifetime
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.