Efficacy of Microneedling With Vitamin C in Performing Gingival Depigmentation

ConditionGingival Pigmentation

Trial statusNot yet recruiting

Trial phasePhase 1, Phase 2

Trial typeInterventional

Biological sexAll

Age18-50

SponsorFayoum University

About this trial

The present study will be carried to clinically evaluate the efficacy of microneedling with vitamin C in performing gingival depigmentation in comparison with conventional scalpel and diode laser.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients with bilateral, diffuse and symmetric physiologic gingival pigmentation in the labial maxillary or mandible gingiva.

Patients free from any systemic diseases according to criteria of Modified Cornell Medical Index. (Abramson J et al., 1966)

Periodontally healthy patient.

Patients with age between 18 and 50 years

Disqualifiers

Smokers.

Drugs intake "mainly those associated with gingival pigmentation".

Pregnant and lactating women.

Patients with thin gingival phenotype "with scalpel group".

Trial design

Design model

Crossover

Treatments tested in this trial

Vitamin C
Drug
Topical ascorbic acid powder, (1,000 mg/mL) mixed with saline will be applied over the gingiva for 10 minutes.
Microneedling
Device
MN will be achieved using a Dermapen device. c) The device allows for adjustable penetration depth, ranging from 0.2 mm to 3 mm, based on the gingival thickness. d) The needle tip comprises 12 to 24 needles arranged in rows, providing six-speed modes that span from 412 cycles/min at the lowest speed to 700 cycles/min at the highest speed. e) The Dermapen will be positioned perpendicular to the gingival surface, and microneedling will be executed horizontally, vertically, and diagonally approximately four to five times f) Across the entire hyperpigmented gingival surface until subtle microbleeding and mild erythema became evident Each individual will be undergoing a total of three treatment sessions of microneedling, spaced out by 10 days
Diode laser
Device
Energy output, pulse duration, and focal distance will be determined based on manufactures instruction. b) Patient, doctor and assistant will wear protective glass before starting the procedure. c) Depigmentation will be carried out using semiconductor Sirolaser Blue With proper isolation, depigmentation procedure will be done. e) Laser ablation will be started from the mucogingival junction toward the free gingival margin, including interdental papilla. f) The laser beam will be applied using the "brush technique," as described by Tal (Tal et al.,2003) and the tip will be kept in motion all the time. g) Remnants of the ablated tissue will be removed using sterile gauze dampened with saline solution
scalpal
Procedure/Surgery
Employing surgical blade number 15c, the gingival epithelium in the pigmented area will be excised. c) The blade will be oriented roughly parallel to the elongated axis of the teeth. d) A meticulous assessment of the revealed connective tissue surface will be performed, and any residual tissue tags will be removed with surgical scissors. e) Hemorrhage control will be managed by applying a pressure pack, and after achieving hemostasis, a periodontal dressing (a non-eugenol zinc oxide dressing) will be administered to cover the wound for one week.

Treatment groups

30 Participants

are divided into 3 treatment groups

Group A: Microneedling with vitamin CActive comparator 2 interventions

Group B: Diode laserActive comparator 1 intervention

Group C: scalpal surgeryActive comparator 1 intervention

Trial outcomes

Primary outcomes

The primary outcome is the efficacy of gingival depigmentation.

The primary outcome is the assessment of how well the treatment removes or reduces the appearance of dark (pigmented) areas on the gums. This is often evaluated using a standardized index like the Degree of Oral Pigmentation Index (DOPI). The efficacy of different techniques ( surgical scalpal, laser, microneedling with vitamin C is then compared based on the degree of pigmentation reduction achieved and the rate of repigmentation over time Degree of gingival pigmentation will be done using Oral Pigmentation Index (Dummett et al ;1964) as following: (0) pink tissue, no clinical pigmentation. 1. mild light brown tissue, mild clinical pigmentation. 2. medium brown or mixed brown and pink tissue, moderate clinical pigmentation. 3. deep brown/blue-black tissue, heavy clinical pigmentation.

Time frame

baseline , 3 months , 6 months

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fayoum University

Lead sponsor

Source ClinicalTrials.gov

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