Active — Not RecruitingPhase 1/2

Effectiveness of Omega-3 Poly Unsaturated Fatty Acids on The Treatment of Gingival Hyperpigmentation

Egypt30 participantsStarted 2024-01-03

Plain-language summary

This new study compares the effectiveness of scalpel surgery and omega-3 poly unsaturated fatty acid (PUF) injections in treating gingival hyperpigmentation.

Who can participate

Age range

21 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: * Patients complained of mild to moderate gingival hyperpigmentation in the anterior area of maxilla. .Systemically healthy subjects with Dummett and Bolden index score 1,2 and 3 having well-maintained oral hygiene, with aesthetic concern and willing to undergo minor surgical procedures. * Adequate oral hygiene conditions. * Age from 21-50 years old. * All patients will be physically healthy with no medical history of any systemic disease that will contraindicate the use of omega-3 (PUFAs) or may complicate the healing process. * Co-operative motivated patients Exclusion Criteria: * The patient with the following criteria will be excluded from the study: * patients complaining of sever gingival hyperpigmentation in the anterior area of maxilla. * Smokers. * Pregnant, lactating (breast feeding) women's. * Patient with allergy to anesthesia * Patients undergoing chemotherapy or radiotherapy

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

Change in gingival pigmentation

Timeframe: measured at baseline, 1 month, 3 month and 6 months postoperative

Trial details

NCT IDNCT07067515

SponsorSuez Canal University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-08-07

View on ClinicalTrials.gov More Hyperpigmentation trials

Who can participate

Age range

21 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.