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

Fayoum University30 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Gingival Pigmentation Gingival Hyperpigmentaion

Interventions

Gingival Depigmentation with Conventional MethodPROCEDURE

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.

Gingival Depigmentation with Diode LaserPROCEDURE

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

Gingival Depigmentation with Microneedling and Silymarin ApplicationPROCEDURE

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.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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 )

Time frame: From the enrollment till 6 months

Secondary Outcomes

post-operative pain

VAS ( visual analogue scale ) from 0 ( no pain ) to 10 ( severe pain )

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