Microneedling with platelet-rich plasma versus microneedling alone for reducing gum (gingival) pigmentation
Microneedling With Platelet Rich Plasma Versus Microneedling Alone For Gingival Depigmentation: A Randomized Controlled Clinical Trial
This test sees if adding platelet-rich plasma (PRP) to microneedling lightens gum pigmentation more than microneedling alone in adults with gingival melanin hyperpigmentation.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 32 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Cairo University Academic / other |
| Locations | 3 sites (Cairo, El Manial and 2 other locations) |
| Trial ID | NCT07359339 on ClinicalTrials.gov |
What this trial studies
Adults with anterior gingival melanin pigmentation receive preoperative ultrasonic scaling and oral hygiene instruction and are randomly assigned to two groups. Both groups receive local infiltration anesthesia and microneedling of the pigmented gingiva with a Dermapen device until mild microbleeding is seen, with clinical photographs taken at baseline, 1 month, and 6 months. The intervention group additionally receives injections of autologous PRP prepared from 10 mL of the patient’s blood, while the control group has microneedling alone. Outcomes compare pigment intensity reduction and clinical appearance over a 6-month follow-up.
Who should consider this trial
Good fit: Adults (≥18 years) with melanin hyperpigmentation in the anterior upper or lower gingiva who are non-smokers and free of systemic disease are ideal candidates.
Not a fit: Patients who are fully edentulous, have endocrine- or drug-related gingival pigmentation, are smokers, pregnant, lactating, or have systemic disease may not benefit or be eligible.
Why it matters
Potential benefit: If successful, this approach could provide a minimally invasive way to reduce gum pigmentation and improve cosmetic appearance.
How similar studies have performed: Microneedling plus PRP has shown benefits for skin pigmentation in dermatology, but its use specifically for gingival depigmentation is novel and not well established.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * • Patients exhibiting melanin hyperpigmentation in the anterior region of the upper or lower gingiva. * Age ≥ 18 year old. * Patients should be free from any systemic diseases according to modified Cornell Medical index (Abramson 1966). * Non- smokers Exclusion Criteria: * • Fully edentulous patients. * Patients with endocrine disorders causing hyperpigmentation or drug induced gingival pigmentation. (Sreeja, Ramakrishnan et al. 2015) * Pregnant or lactating females.
Where this trial is running
Cairo, El Manial and 2 other locations
- Cairo university — Cairo, El Manial, Egypt (Recruiting)
- Faculity of Dentistry, Cairo university — Cairo, El Manyl, Egypt (Recruiting)
- Faculity of Dentistry, Cairo university — Cairo, El Manyl, Egypt (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.