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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorFayoum University

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Gingival Depigmentation with Conventional Method

    Procedure/Surgery

    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 Laser

    Procedure/Surgery

    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 Application

    Procedure/Surgery

    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.

Treatment groups

30 Participants
are divided into 3 treatment groups
Group A: Conventional Surgical methodOther 1 intervention
Group B: Diode LaserActive comparator 1 intervention
Group C: MN with Silymarin applicationActive comparator 1 intervention

Trial outcomes

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 )

Time frame
From the enrollment till 6 months

Secondary outcomes

1

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 )

Other outcomes

1

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

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

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