RecruitingNot ApplicableNCT07410156

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

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


Sponsor

Fayoum University

Enrollment

30 participants

Start Date

Jul 1, 2026

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a procedure called Gingival Depigmentation with Conventional Method, a procedure called Gingival Depigmentation with Diode Laser, and others for people with gingival hyperpigmentaion and gingival pigmentation. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREGingival Depigmentation with Conventional Method

Under aseptic conditions and infiltration anaesthesia, The gingiva of the facial surfaces of the selected area will be de-epithelized by using the blade till complete removal of the depigmented tissue reached method through blades no 15c till the entire pigmented area is resolved.

PROCEDUREGingival Depigmentation with Diode Laser

Under aseptic conditions and infiltration anaesthesia, The gingiva of the facial surfaces of the selected area will be de-epithelized by A Diode laser Device (serolaser) in a free running pulse mode. Remnants of the ablated tissue will be removed using sterile gauze dampened with saline. The procedure will be performed from a cervico-apical direction in all pigmented areas

PROCEDUREGingival Depigmentation with Microneedling and Silymarin Application

Under aseptic conditions and infiltration anaesthesia, The gingiva of the facial surfaces of the selected area will be treated by repetitive punctures with Dr.Pen ULTIMA - A6 needle tip. The needle tip features six speed settings, ranging from 412 to 700 cycles per minute, with 12-24 needles arranged in rows. Healthcare professionals can treat areas in back and forth motion for 30- 40 seconds. Changing the needle length is simple with guides. Using the same handpiece for several patient applications is made possible by disposable needletips. Silymarin is applied topically for ten minutes.


Locations(1)

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

Al Fayyum, Egypt

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NCT07410156


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