Comparison of Er-YAG Laser, Air Polishing, and Surgical Excision for Gingival Hyperpigmentation (NCT07672587) | Clinical Trial Compass
CompletedNot Applicable
Comparison of Er-YAG Laser, Air Polishing, and Surgical Excision for Gingival Hyperpigmentation
Turkey (Türkiye)24 participantsStarted 2025-12-01
Plain-language summary
This randomized controlled clinical trial aimed to compare the effectiveness of different treatment approaches for physiologic gingival hyperpigmentation. Participants with gingival melanin pigmentation were randomly assigned to one of four treatment groups: Er:YAG laser treatment, air polishing with erythritol powder, air polishing with sodium bicarbonate powder, or conventional surgical excision. Clinical outcomes were evaluated using pigmentation index scores, digital image analysis, and color measurements at baseline and follow-up visits. Patient-centered outcomes, including postoperative discomfort and satisfaction, were also assessed. The study sought to determine whether air polishing techniques could provide clinical outcomes comparable to conventional treatment approaches while improving patient comfort and satisfaction.
Who can participate
Age range
18 Years – 50 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:
* Individuals aged between 18 and 50 years
* Systemically healthy individuals
* Presence of physiologic gingival hyperpigmentation in the anterior maxillary or mandibular gingiva
* Individuals seeking esthetic treatment for gingival pigmentation
* Presence of adequate oral hygiene and periodontal health before treatment
* Willingness to participate in the study and provide written informed consent
* Agreement to attend all follow-up visits during the study period
Exclusion Criteria:
* Presence of systemic diseases or conditions that may affect wound healing
* Smoking or use of tobacco products
* Pregnancy or lactation
* History of periodontal therapy or gingival depigmentation treatment in the study area
* Presence of active periodontal disease or gingival inflammation at baseline
* Use of medications affecting gingival tissues or wound healing
* Individuals with non-physiologic oral pigmentation associated with systemic disorders, medication use, or syndromic conditions
* Inability or unwillingness to comply with study protocol and follow-up visits
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 RGB Color Values
Timeframe: Baseline, 7 days after treatment, 1 month after treatment, and 3 months after treatment
2
Color Difference (Delta E)
Timeframe: 7 days after treatment, 1 month after treatment, and 3 months after treatment
3
Change in Pigmented Area
Timeframe: Baseline, 7 days after treatment, 1 month after treatment, and 3 months after treatment
4
Change in Dummett Oral Pigmentation Index (DOPI)
Timeframe: Baseline, 1 months after treatment, 3 months after treatment