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Clinical Trials/CTRI/2026/03/105598
CTRI/2026/03/105598Not yet recruitingPhase 1/2

A COMPARATIVE ANALYSIS OF HEALING, REPIGMENTATION AND PAIN DURING GINGIVAL DEPIGMENTATION USING CONVENTIONAL SURGICAL METHOD, DIODE LASER AND MICRONEEDLING – A RANDOMIZED CLINICAL TRIAL

College of Dental Science and hospital1 site in 1 country45 target enrollmentStarted: March 18, 2026Last updated:

Trial Snapshot

Phase
Phase 1/2
Status
Not yet recruiting
Sponsor
Enrollment
45
Locations
1

Study Overview

Brief Summary

15-40 years aged patients reporting to the Department of Periodontology at the College of Dental Science and hospital, Amargadh with bimaxillary melanin hyperpigmentation in the facial aspects of anterior regions will be considered inclusion criteria for the study. A total of 45 patients will be selected for the study to evaluate and compare the healing, repigmentation and pain during gingival depigmentation using conventional surgical method using scalpel, Diode LASER and microneedling. This study will be done to evaluate whether microneedling can be considered a better alternative for depigmentation over Diode LASER and conventional scalpel method.

Study Design

Study Type
Interventional
Allocation
Coin toss, Lottery, toss of dice, shuffling cards etc
Masking
None

Eligibility Criteria

Ages
15.00 Year(s) to 40.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • 40 years age group •Both Male and Female •Periodontally healthy subjects •Bimaxillary melanin hyperpigmentation in the facial aspects of anterior regions with moderate or heavy clinical pigmentation according to Dummett and Gupta index.

Exclusion Criteria

  • Systemically compromised Patients •Patient with smoking habit •Patient using drugs with potential to cause oral pigmentation •Pregnant and lactating women •Subjects with thin gingival biotype.

Investigators

Sponsor
College of Dental Science and hospital
Sponsor Class
Private medical college
Responsible Party
Principal Investigator
Principal Investigator

Kena Gajjar

College of Dental Science and Hospital, Amargadh

Study Sites (1)

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