About this 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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
Pregnant and lactating women
Systemic conditions affect melanin production
Medications induce pigmentation or enlargement
Those with known allergies to silymarin.
Trial design
Parallel
Treatments tested in this trial
Gingival Depigmentation with Conventional Method
Procedure/SurgeryUnder 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 Laser
Procedure/SurgeryUnder 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 Application
Procedure/SurgeryUnder 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.
Treatment groups
Trial 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 )
Secondary outcomes
post-operative pain
VAS ( visual analogue scale ) from 0 ( no pain ) to 10 ( severe pain )
Other outcomes
Wound Healing
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
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