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Efficacy of Microneedling With Vitamin C in Performing Gingival Depigmentation

NCT07070024 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-07-17

No results posted yet for this study

Summary

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.

Conditions

  • Gingival Pigmentation

Interventions

DEVICE

Diode laser

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

PROCEDURE

scalpal

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.

DRUG

Vitamin C

Topical ascorbic acid powder, (1,000 mg/mL) mixed with saline will be applied over the gingiva for 10 minutes.

DEVICE

Microneedling

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

Sponsors & Collaborators

  • Fayoum University

    lead OTHER

Principal Investigators

  • Rehab Ahmed Dr/ Rehab Ahmed Osman, Lecturer · faculty of dentistry Fayoum university

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-31
Primary Completion
2026-07-01
Completion
2026-12-31
FDA Device
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07070024 on ClinicalTrials.gov