CompletedNot Applicable

Melanin Recurrence in Scalpel and LASER Gingival Depigmentation in Thin and Thick Phenotypes.

Yemen30 participantsStarted 2024-03-04

Plain-language summary

This study aimed to compare melanin pigmentation recurrence, pain perception and wound healing between laser and scalpel surgeries in thin and thick gingival phenotypes.Thirty patients (60 sites) were included in this study. They had bilateral physiologic melanin hyperpigmentation in the upper anterior segment with severe grade II melanin hyperpigmentation. The patients were divided into two groups: each with fifteen patients with severe grade II melanin pigmentation, one with thin gingiva and another with thick gingiva. Melanin depigmentation was done in one side using scalpel no. 15 and other side with diode laser.

Who can participate

Age range

20 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: (i) Be aged at least 20 years, (ii) had bilateral physiologic melanin hyperpigmentation of gingiva (dark gums) in the anterior segment with severe grade II melanin hyperpigmentation (according to modification of melanin index categories 1977), (iii) periodontally healthy with good oral hygiene, (iv) had esthetic concern, (v) systemically healthy, (vi) no dental crowding and (vii) those willing to undergo minor surgical procedures. Exclusion Criteria: (i) any systemic disease associated with pathological hyperpigmentation), (ii) non-treated periodontal disease, (iii) chronic smokers, (iv) subjects with a mouth breathing habit (ii) subjects with crown restorations or fillings involving the incisal edge on anterior maxillary teeth, (v) non-compliant patients (vi) missing any of the six maxillary anterior teeth and having Millers Class III or Class IV recession (vii) pregnant or lactating females and (viii) (ix) gingival pigmentation of hemoglobin, melanoid, melanoma and carotene , (x) Gingival pigmentation adjacent to amalgam restoration, and (xi) Long-term usage of antimalarial drugs and minocycline.

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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?

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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

Melanin recurrence

Timeframe: One week, three months, and six months postoperatively

Trial details

NCT IDNCT06886100

SponsorThamar University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-12-18

View on ClinicalTrials.gov More Melanin Hyperpigmentation trials