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Microneedling With Platelet Rich Plasma Versus Microneedling Alone For Gingival Depigmentation: A Randomized Controlled Clinical Trial
Led by Cairo University · Updated on 2026-01-22
32
Participants Needed
3
Research Sites
5 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to compare the effects of microneedling combined with platelet rich plasma (PRP) to microneedling alone for reducing gingival pigmentation. It focuses on patients with melanin hyperpigmentation in the front upper or lower gums. The study is randomized and controlled, assessing pigment intensity reduction and related outcomes over time. Participants receive local anesthesia before treatment. A Dermapen device with 24 microneedles is used to microneedle the pigmented gum tissue in multiple directions until mild microbleeding and redness appear. The intervention group also receives injections of PRP prepared from their own blood. The control group undergoes microneedling alone. Postoperative care includes instructions on oral hygiene, pain management with analgesics if needed, antiseptic mouth rinses, and dietary restrictions to support healing. Participants are followed closely with clinical photographs taken before treatment, and at 1 and 6 months after the procedure. Researchers measure gum pigmentation using the Dummett-Gupta Oral Pigmentation Index at six months and assess pain at seven days. The study includes safety monitoring and adherence to care instructions. Total participation spans at least six months from initial treatment to final assessment.
CONDITIONS
Brief Title
Microneedling With Platelet Rich Plasma Versus Microneedling Alone For Gingival Depigmentation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients exhibiting melanin hyperpigmentation in the anterior region of the upper or lower gingiva.
- Age 18 years or older.
- Patients free from any systemic diseases according to modified Cornell Medical index.
- Non-smokers.
You will not qualify if you...
- Fully edentulous patients.
- Patients with endocrine disorders causing hyperpigmentation or drug-induced gingival pigmentation.
- Pregnant or lactating females.
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single treatment visit with 14 days of postoperative care instructions
Participants undergo microneedling of the gingival tissue using a Dermapen device. In one group, platelet rich plasma (PRP) is injected into the gingiva immediately after microneedling. Local anesthesia is administered before the procedure. Postoperative care instructions include avoiding mechanical oral hygiene in the treated area on the day of the procedure, using prescribed antiseptic mouth rinse twice daily for 14 days, applying ice packs for 24 hours, and possibly taking analgesics if discomfort occurs.
1 visit (in-person) plus postoperative instructions
Duration - Up to 6 months
Participants are monitored for pain and pigmentation changes after treatment, including assessment of oral pigmentation at 6 months and pain evaluation at 7 days post intervention.
1 visit at 7 days and 1 visit at 6 months (in-person)
Trial Site Locations
Total: 3 locations
1
Cairo university
Cairo, El Manial, Egypt, 11562
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2
Faculity of Dentistry, Cairo university
Cairo, El Manyl, Egypt, 11555
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3
Faculity of Dentistry, Cairo university
Cairo, El Manyl, Egypt, 11555
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How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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