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NCT07410156 | RECRUITING | Gingival Pigmentation

Clinical Evaluation of Microneedling Technique With Topical Application of Silymarin on Gingival Hyperpigmentation in Comparison With Diode Laser and Scalpel Methods.
Sponsor:

Fayoum University

Information provided by (Responsible Party):

Tariq Taha Amin Abdel Tawab

Brief Summary:

The present study will be carried to evaluate the efficacy of MN technique with topical Silymarin application in treating gingival hyperpigmentation in comparison with Laser and scalpel methods. This evaluation will be done clinically. The questions to be answered: * Is there a statistical difference between the microneedling (MN) technique with topical silymarin application, the scalpel technique, and the diode laser in providing clinical and aesthetic advantages in the treatment of gingival pigmentation? * What medical problems do participants have when using of Silymarin topically? Participants will be: Group 1 : The gingiva of the facial surfaces of the selected area will be de-epithelized by conventional method through blades no 15c. Group 2 : The gingiva of the facial surfaces of the selected area will be de-epithelized by A Diode laser Device (serolaser). Group 3 : The gingiva of the facial surfaces of the selected area will be treated by repetitive punctures with Dr.Pen ULTIMA - A6 needle tip. Silymarin is applied topically for ten minutes.

Condition or disease

Gingival Pigmentation

Gingival Hyperpigmentaion

Intervention/treatment

Gingival Depigmentation with Conventional Method

Gingival Depigmentation with Diode Laser

Gingival Depigmentation with Microneedling and Silymarin Application

Phase

NA

Study Type : INTERVENTIONAL
Estimated Enrollment : 30 participants
Masking : DOUBLE
Masking Description : Masking Description
Primary Purpose : TREATMENT
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
Actual Study Start Date : 2026-07-01
Estimated Primary Completion Date : 2027-07
Estimated Study Completion Date : 2027-12

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: 1
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.
Clinical Evaluation of Microneedling Technique With Topical Application of Silymarin on Gingival Hyperpigmentation in Comparison With Diode Laser and Scalpel Methods.

Location Details

NCT07410156

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How to Participate

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Locations

RECRUITING

Egypt,

Fayoum University, Faculty of Dentistry, Department of Oral Medicine and Periodontology

Al Fiume, Egypt,