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

NCT07410156 | Recruiting DMC

• 1 other identifier: MN+Silymarin for depigmenation
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Gingival Pigmentation; Gingival Hyperpigmentaion

Keywords

Gingival depigmentation; Microneedling; Laser; Silymarin; Scalpel; Surgical depigmentation; Micro-needling; MN; Topical application; gingival hyperpigmentation

Outcome Measures

Primary Outcomes (1)

• Gingival Pigmentation Recurrence

  Visual assessment will be the way to measure how the gingiva is depigmented through DOPI score from 1 ( no pigments ) to 4 ( maximum pigments )

  From the enrollment till 6 months

Secondary Outcomes (1)

• post-operative pain

  pain will recoreded at 1,3,5,7days after the treatment ( from intervention till 1 week )

Other Outcomes (1)

• Wound Healing

  wound healing will recorded at 7,14,30 days postoperative ( from enrollment till 4 weeks )

Study Arms (3)

Conventional Surgical method

OTHER

depigmentation done using scalpel blade NO15 c

Procedure: Gingival Depigmentation with Conventional Method

Diode Laser

ACTIVE COMPARATOR

diode lase with wave length 980 and laser tip 320 micron

Procedure: Gingival Depigmentation with Diode Laser

MN with Silymarin application

ACTIVE COMPARATOR

micro needling device Dr.Pen ULTIMA- M8 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. with topical application. Silymarin is applied topically for ten minutes at concentration 7mg/ml.

Procedure: Gingival Depigmentation with Microneedling and Silymarin Application

Interventions

Gingival Depigmentation with Conventional Method PROCEDURE

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.

Also known as: Scalpel depigmentation

Conventional Surgical method

Gingival Depigmentation with Diode Laser PROCEDURE

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

Also known as: Laser depigmentation

Diode Laser

Gingival Depigmentation with Microneedling and Silymarin Application PROCEDURE

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.

MN with Silymarin application

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients will be free from any systemic diseases according to criteria of Modified Cornell Medical Index
• Patient with physiologic pigmentation
• Non smoker
• Patient agree to sign the written consent
• Both genders

You may not qualify if:

• Pregnant and lactating women
• Systemic conditions affect melanin production
• Medications induce pigmentation or enlargement
• Those with known allergies to silymarin.

Sponsors & Collaborators

• Fayoum University: lead

Study Sites (1)

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

Al Fayyum, Egypt

RECRUITING

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Related Links

• Related Info

MeSH Terms

Interventions

Lasers, Semiconductor; Percutaneous Collagen Induction

Intervention Hierarchy (Ancestors)

Lasers; Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Punctures; Rehabilitation

Study Officials

• Nayroz Mohammed Tarrad, Professor

  Oral Medicine and Periodontology Faculty of Dentistry, Fayoum University

  PRINCIPAL INVESTIGATOR

• Rehab Ahmed Osman, Lecturer

  Oral Medicine and Periodontology Faculty of Dentistry, Fayoum University

  STUDY DIRECTOR

Central Study Contacts

Tarek Taha TTAAbdeltawab, Researcher

CONTACT

+201100892663; tt1139@fayoum.edu.eg

Rehab Ahmed Osman, Lecturer

CONTACT

+201096992996; rau11@fayoum.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Masking Description
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Operator

Study Record Dates

• First Submitted: November 15, 2025
• First Posted: February 13, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: February 13, 2026

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)