Comparison of Gingival Depigmentation Using Microneedling and Microneedling With Glutathione Gel - A Split Mouth Clinical Trial

August 2, 2026 updated by: Dr Prabhuji MLV, Krishnadevaraya College of Dental Sciences & Hospital
The colour of gingiva is important determinant of smile esthetics.Owing to increasing awareness and demand for cosmetic procedures over the past decade, gingival depigmentation has gained popularity among periodontal plastic surgical procedures.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

various treatment modalities for depigmentation has been used over the decades. Microneedling is a minimally invasive procedure that creates micro pores on the gingiva which stimulates the natural healing process and improve penetration of topical agents.Glutathione when used has shown promising results in reducing pigmentation which is a major concern with the treatment. In this study 15 patients meeting the eligibility criteria has been randomly assigned to either of the arms.

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Kranataka
      • Bangalore, Kranataka, India, 562157
        • Krishnadevaraya college of dental sciences and hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients between the age group of 18 to 45 years
  • Systemically healthy subjects
  • Maxillary or mandibular keratinised gingiva with minimum mean SEMPI score of 1(light grey / brown pigmentation) and above.

Exclusion Criteria:

  • Patients with thin gingival phenotype(<1mm)
  • Patients on drugs that cause oral pigmentation like antimalarials,minocycline, oral contraceptives etc.,
  • Systemic disorders that cause oral pigmentation ,Pregnant and lactating women
  • Subjects with history of smoking.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Microneedling using Dermapen device
Device: Microneedling using Dermapen device
Dermapen device that is being used for microneedling creates micro conuits because of whuch wound healing will bee improved and it helps penetration of agents effectively
Experimental: Microneedling with 0.5% Glutathione gel
In this arm dermapen device is used to reduce pigmentation
Device: Microneedling using Dermapen device
Dermapen device that is being used for microneedling creates micro conuits because of whuch wound healing will bee improved and it helps penetration of agents effectively
Other: Microneedling with 0.5 % Glutathione gel
Usage of micreoneedling with topical application of 0.5% glutathione gel as an adjunct

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of Gingival pigmentation using SEMPI index
Time Frame: baseline, 1 month, 3 months, 6 months
Severity and Extension of Gingival Melanotic Pigmentation Index is used for assessing the gingival pigmentation
baseline, 1 month, 3 months, 6 months
Assessment of pigment surface area using Image J analysis software
Time Frame: baseline, 1 month, 3 months, 6 months
baseline, 1 month, 3 months, 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of repigmentation
Time Frame: 6 months
Repigmentation rate assessed using change in sempi score and pigment surface area on image J over the period
6 months
patient reported pain or discomfort
Time Frame: at the time of treatment , 1 month
using visual analog scale
at the time of treatment , 1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Krishnadevaraya College of Dental Sciences & Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 25, 2025

Primary Completion (Actual)

December 28, 2025

Study Completion (Actual)

July 28, 2026

Study Registration Dates

First Submitted

July 28, 2026

First Submitted That Met QC Criteria

August 2, 2026

First Posted (Actual)

August 5, 2026

Study Record Updates

Last Update Posted (Actual)

August 5, 2026

Last Update Submitted That Met QC Criteria

August 2, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 02_D012_00116

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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