Microneedling with topical silymarin versus diode laser and scalpel for gingival pigmentation
Clinical Evaluation of Microneedling Technique With Topical Application of Silymarin on Gingival Hyperpigmentation in Comparison With Diode Laser and Scalpel Methods. A Randomized Clinical Trial
We will test whether microneedling plus topical silymarin, diode laser, or scalpel works better to improve the appearance of gums in people with gingival hyperpigmentation.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fayoum University Academic / other |
| Locations | 1 site (Al Fayyum) |
| Trial ID | NCT07410156 on ClinicalTrials.gov |
What this trial studies
This single-center interventional comparison will treat selected gingival sites by one of three methods: scalpel de-epithelialization using a No. 15c blade, diode laser (serolaser) ablation, or repetitive microneedling with a Dr.Pen device followed by topical silymarin application. Clinical and aesthetic outcomes, healing, and any adverse effects will be recorded and compared across groups. Eligible non-smoking adults with physiologic gingival pigmentation and no systemic conditions or silymarin allergy will be enrolled after informed consent. All procedures and follow-up visits will be conducted at Fayoum University Faculty of Dentistry.
Who should consider this trial
Good fit: Adults with physiologic gingival hyperpigmentation who are non-smokers, free of systemic disease, not pregnant or lactating, and without allergy to silymarin.
Not a fit: People with medication- or disease-related pigmentation, smokers, pregnant or breastfeeding women, or those allergic to silymarin likely would not benefit or are excluded.
Why it matters
Potential benefit: If successful, this could offer a less invasive or better-tolerated option that improves gum color with comparable safety and faster healing.
How similar studies have performed: Scalpel and diode laser methods are established and have shown positive results for gingival depigmentation, while microneedling with topical silymarin is a novel approach with limited prior evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients will be free from any systemic diseases according to criteria of Modified Cornell Medical Index 2. Patient with physiologic pigmentation 3. Non smoker 4. Patient agree to sign the written consent 5. Both genders Exclusion Criteria: 1. Pregnant and lactating women 2. Systemic conditions affect melanin production 3. Medications induce pigmentation or enlargement 4. Those with known allergies to silymarin.
Where this trial is running
Al Fayyum
- Fayoum University, Faculty of Dentistry, Department of Oral Medicine and Periodontology — Al Fayyum, Egypt (Recruiting)
Study contacts
- Principal investigator: Nayroz Mohammed Tarrad, Professor — Oral Medicine and Periodontology Faculty of Dentistry, Fayoum University
- Study coordinator: Tarek Taha TTAAbdeltawab, Researcher
- Email: tt1139@fayoum.edu.eg
- Phone: +201100892663
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.