NCT07410156 Clinical Evaluation of Microneedling Technique With Topical Application of Silymarin on Gingival Hyperpigmentation in Comparison With Diode Laser and Scalpel Methods.
| NCT ID | NCT07410156 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fayoum University |
| Condition | Gingival Pigmentation |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2026-07-01 |
| Primary Completion | 2027-07 |
Trial Parameters
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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.
Eligibility 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.