CompletedPhase 4

Effect of Injectable Platelet Rich Fibrin on Healing and Patient Satisfaction Following Laser Gingival Depigmentation

Egypt8 participantsStarted 2020-02-20

Plain-language summary

The objectives of the present study are to: 1. Evaluate the effect of I-PRF injection following laser gingival depigmentation technique on the healing period as a primary objective. 2. Assess patient satisfaction following the procedure in terms of pain and esthetic outcome as a secondary objective.

Who can participate

Age range

16 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: * Male and female with age range from 16 to 45 years old. * Systemically free from any disease as evidenced by the health questionnaire guided by modified Cornell medical index (Pendleton et al., 2004). * Gingival hyperpigmentation on maxillary and mandibular labial keratinized gingiva score 3 (Dummett et al., 1964). * Patient with thick gingival phenotype (\>1.5mm) (Claffey and Shanley, 1986). Exclusion Criteria * Pregnant and lactating women. * Smokers. * Gingival pigmentation associated with occupational Hazards. * Patients with missing anterior teeth. * Patients with any metallic restoration related to anterior teeth or undergoing orthodontic treatment. * Vulnerable groups (prisoners, handicapped and orphans).

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

Dummet oral pigmentation index

Timeframe: 1 month

Clinical wound healing

Timeframe: 1 week

Trial details

NCT IDNCT05283668

SponsorAin Shams University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-01-20

View on ClinicalTrials.gov More Gingival Pigmentation trials