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

February 7, 2026 updated by: Tarek Taha Amin Abdeltawab, Fayoum University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Tarek Taha TTAAbdeltawab, Researcher
  • Phone Number: +201060406261 +201100892663
  • Email: tt1139@fayoum.edu.eg

Study Contact Backup

  • Name: Rehab Ahmed Osman, Lecturer
  • Phone Number: +201153832971 +201096992996
  • Email: rau11@fayoum.edu.eg

Study Locations

  • Egypt
      • Al Fayyum, Egypt
        • Recruiting
        • Fayoum University, Faculty of Dentistry, Department of Oral Medicine and Periodontology
        • Contact:
        • Principal Investigator:
          • Nayroz Mohammed Tarrad, Professor
        • Sub-Investigator:
          • Rehab Ahmed Osman, Lecturer

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Conventional Surgical method
depigmentation done using scalpel blade NO15 c
Procedure: Gingival 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.
Other Names:
  • Scalpel depigmentation
Active Comparator: Diode Laser
diode lase with wave length 980 and laser tip 320 micron
Procedure: Gingival 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
Other Names:
  • Laser depigmentation
Active Comparator: MN with Silymarin application
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gingival Pigmentation Recurrence
Time Frame: From the enrollment till 6 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
post-operative pain
Time Frame: pain will recoreded at 1,3,5,7days after the treatment ( from intervention till 1 week )
VAS ( visual analogue scale ) from 0 ( no pain ) to 10 ( severe pain )
pain will recoreded at 1,3,5,7days after the treatment ( from intervention till 1 week )

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Wound Healing
Time Frame: wound healing will recorded at 7,14,30 days postoperative ( from enrollment till 4 weeks )
Wound healing index Score 1 : Uneventful healing with no gingival oedema, erythema, suppuration, patient discomfort, or flap dehiscence Score 2 : Uneventful healing with slight gingival oedema, erythema, patient discomfort, or flap dehiscence, but no suppuration Score 3 : Poor wound healing with significant gingival oedema, erythema, patient discomfort, flap dehiscence, or any suppuration
wound healing will recorded at 7,14,30 days postoperative ( from enrollment till 4 weeks )

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fayoum University

Investigators

  • Principal Investigator: Nayroz Mohammed Tarrad, Professor, Oral Medicine and Periodontology Faculty of Dentistry, Fayoum University
  • Study Director: Rehab Ahmed Osman, Lecturer, Oral Medicine and Periodontology Faculty of Dentistry, Fayoum University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2026

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

November 15, 2025

First Submitted That Met QC Criteria

February 7, 2026

First Posted (Actual)

February 13, 2026

Study Record Updates

Last Update Posted (Actual)

February 13, 2026

Last Update Submitted That Met QC Criteria

February 7, 2026

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MN+Silymarin for depigmenation

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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