Gingival involvement in a case series of patients with acquired immunodeficiency syndrome-related Kaposi sarcoma.
Christos D R Kalpidis, Stella N Lysitsa, Tommaso Lombardi...
https://pubmed.ncbi.nlm.nih.gov/16512768Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
ID07410156
Clinical Evaluation of Microneedling Technique With Topical Application of Silymarin on Gingival Hyperpigmentation Compared to Diode Laser and Scalpel Methods A Randomized Clinical Trial
Led by Fayoum University · Updated on 2026-02-13
30
Participants Needed
1
Research Sites
21 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness of the microneedling technique combined with topical silymarin application in treating gingival hyperpigmentation. This study compares this method with conventional scalpel and diode laser treatments to determine any clinical or aesthetic advantages. It also aims to identify any medical issues participants may experience when using topical silymarin. Participants will be divided into three groups: one receiving scalpel de-epithelization, another treated with a diode laser device, and the third undergoing microneedling with the Dr.Pen ULTIMA - A6 needle tip, followed by topical application of silymarin for ten minutes. The laser uses a wavelength of 980 nm with a 320-micron tip, while microneedling involves repetitive punctures at various speeds and needle arrangements. During the study, researchers will monitor gingival pigmentation recurrence over six months and record post-operative pain on days 1, 3, 5, and 7 after treatment. The study includes assessments of clinical and aesthetic outcomes to evaluate the treatments. Participants will be observed for any adverse effects, especially related to silymarin use, throughout the follow-up period.
CONDITIONS
Brief Title
Clinical Evaluation of Microneedling Technique With Topical Application of Silymarin on Gingival Hyperpigmentation in Comparison With Diode Laser and Scalpel Methods.
Who Can Participate
Age: 18Years +
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Patients free from systemic diseases according to Modified Cornell Medical Index
- Patients with physiological gingival pigmentation
- Non-smokers
- Patients who agree to sign written consent
- Both genders
You will not qualify if you...
- Pregnant and lactating women
- Systemic conditions affecting melanin production
- Use of medications that induce pigmentation or enlargement
- Known allergies to silymarin
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Single treatment session
Participants receive gingival depigmentation using one of three methods: conventional scalpel, diode laser, or microneedling with topical silymarin application.
1 treatment visit (in-person)
Post-operative Follow-up
Duration - 1 week
Participants are monitored for post-operative pain and recovery after the treatment.
4 visits (days 1, 3, 5, and 7 post-treatment, in-person)
Long-term Monitoring
Duration - 6 months
Participants are followed to assess gingival pigmentation recurrence over 6 months.
Periodic follow-up visits during 6 months
Trial Site Locations
Total: 1 location
1
Fayoum University, Faculty of Dentistry, Department of Oral Medicine and Periodontology
Al Fayyum, Egypt
Actively Recruiting
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Research Team
T
Tarek Taha TTAAbdeltawab, Researcher
R
Rehab Ahmed Osman, Lecturer
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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