CompletedNot Applicable

Comparison of Gingival Depigmentation Using Microneedling and Microneedling With Glutathione Gel - A Split Mouth Clinical Trial

India15 participantsStarted 2025-06-25

Plain-language summary

The colour of gingiva is important determinant of smile esthetics.Owing to increasing awareness and demand for cosmetic procedures over the past decade, gingival depigmentation has gained popularity among periodontal plastic surgical procedures.

Who can participate

Age range

18 Years – 45 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: * Patients between the age group of 18 to 45 years * Systemically healthy subjects * Maxillary or mandibular keratinised gingiva with minimum mean SEMPI score of 1(light grey / brown pigmentation) and above. Exclusion Criteria: * Patients with thin gingival phenotype(\<1mm) * Patients on drugs that cause oral pigmentation like antimalarials,minocycline, oral contraceptives etc., * Systemic disorders that cause oral pigmentation ,Pregnant and lactating women * Subjects with history of smoking.

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

Assessment of Gingival pigmentation using SEMPI index

Timeframe: baseline, 1 month, 3 months, 6 months

Assessment of pigment surface area using Image J analysis software

Timeframe: baseline, 1 month, 3 months, 6 months

Trial details

NCT IDNCT07748507

SponsorKrishnadevaraya College of Dental Sciences & Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-12-28

View on ClinicalTrials.gov More Gingiival Hyperpigmentation trials

Who can participate

Age range

18 Years – 45 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.