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

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07410156

Acronym

Depigmentation

Enrollment

Registered

2026-02-13

Start date

2026-07-01

Completion date

2027-12-01

Last updated

2026-02-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gingival Hyperpigmentaion, Gingival Pigmentation

Keywords

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

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.

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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Investigator, Outcomes Assessor)

Masking description

Masking Description

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
Gingival Pigmentation Recurrence	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 )

Secondary

Measure	Time frame	Description
post-operative pain	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 )

Countries

Egypt

Contacts

CONTACTTarek Taha TTAAbdeltawab, Researcher

tt1139@fayoum.edu.eg+201100892663

CONTACTRehab Ahmed Osman, Lecturer

rau11@fayoum.edu.eg+201096992996

PRINCIPAL_INVESTIGATORNayroz Mohammed Tarrad, Professor

Oral Medicine and Periodontology Faculty of Dentistry, Fayoum University

STUDY_DIRECTORRehab Ahmed Osman, Lecturer