Microneedling with topical silymarin versus diode laser and scalpel for gingival pigmentation
Official title: 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
Run by Fayoum University · NCT07410156 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 30 (estimated) |
| Sponsor | Fayoum University Academic / other |
| Locations | 1 site (Al Fayyum) |
| Status | Recruiting |
| Started | July 1, 2026 |
| Main results expected | July 2027 |
| Study ends | December 2027 |
| Registry record updated | February 13, 2026 |
| Trial ID | NCT07410156 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with physiologic gingival hyperpigmentation who are non-smokers, free of systemic disease, not pregnant or lactating, and without allergy to silymarin.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Gingival Depigmentation with Vitamin C and Glutathione vs. Surgical Depigmentation
This study tests whether vitamin C with glutathione injections can depigment pigmented gums as effectively as surgical depigmentation in adults.
-
Microneedling with platelet-rich plasma versus microneedling alone for reducing gum (gingival) pigmentation
This test sees if adding platelet-rich plasma (PRP) to microneedling lightens gum pigmentation more than microneedling alone in adults with gingival melanin hyperpigmentation.
-
Vitamin C to lighten dark gum pigmentation
This trial will try three ways of applying vitamin C—topical gel, microneedling, and mesotherapy—to see if they reduce dark gum pigmentation in healthy adults aged 20 to 35.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.