Gingival Depigmentation With Diode and Er,Cr:YSGG Laser: A Split-mouth Trial (NCT07520266) | Clinical Trial Compass
CompletedNot Applicable
Gingival Depigmentation With Diode and Er,Cr:YSGG Laser: A Split-mouth Trial
Vietnam38 participantsStarted 2023-03-01
Plain-language summary
Gingival hyperpigmentation is a common physiological condition caused by excessive melanin deposition in oral mucosa, negatively affecting smile esthetics. Laser therapy has become an effective treatment option due to advantages such as minimal bleeding, reduced postoperative discomfort, and faster healing.
This clinical study aims to evaluate clinical characteristics of gingival pigmentation and compare treatment outcomes between diode laser and Er,Cr:YSGG laser techniques. Outcomes include pigmentation reduction, postoperative pain, wound healing, bleeding, patient satisfaction, and recurrence rate.
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:
* all patients exhibiting physiological melanin hyperpigmentation of score 1 or more according to the oral pigmentation index (DOPI) in the buccal maxillary gingiva
Exclusion Criteria:
* history of systemic diseases related to pathology
* participants with a systemic condition that could affect tissue healing (e.g., uncontrolled diabetes, autoimmune diseases, HIV, leukemia, etc.)
* pregnancy and lactation
* a history of smoking; previously used drugs (related to pigmentation) before the intervention within the last 6 months
* contraindication for laser treatment.
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
Change in gingival pigmentation measured by Dummett-Gupta Oral Pigmentation Index (DOPI)
Timeframe: Baseline, 7 days, 1 month, 3 months
2
Change in gingival pigmentation measured by Melanin Pigmentation Index (MPI)
Timeframe: Baseline, 7 days, 1 month, 3 months
Trial details
NCT IDNCT07520266
SponsorCan Tho University of Medicine and Pharmacy