NCT07748507

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2025

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 25, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 28, 2025

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 28, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 28, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 5, 2026

Completed
Last Updated

August 5, 2026

Status Verified

August 1, 2026

Enrollment Period

6 months

First QC Date

July 28, 2026

Last Update Submit

August 2, 2026

Conditions

Gingiival Hyperpigmentation

Keywords

MicroneedlingGlutathioneDepigmentationRepigmentation

Outcome Measures

Primary Outcomes (2)

  • Assessment of Gingival pigmentation using SEMPI index

    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

    baseline, 1 month, 3 months, 6 months

Secondary Outcomes (2)

  • Rate of repigmentation

    6 months

  • patient reported pain or discomfort

    at the time of treatment , 1 month

Study Arms (2)

Microneedling using Dermapen device

EXPERIMENTAL
Device: Microneedling using Dermapen device

Microneedling with 0.5% Glutathione gel

EXPERIMENTAL

In this arm dermapen device is used to reduce pigmentation

Device: Microneedling using Dermapen deviceOther: Microneedling with 0.5 % Glutathione gel

Interventions

Microneedling using Dermapen deviceDEVICE

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

Microneedling using Dermapen deviceMicroneedling with 0.5% Glutathione gel
Microneedling with 0.5 % Glutathione gelOTHER

Usage of micreoneedling with topical application of 0.5% glutathione gel as an adjunct

Microneedling with 0.5% Glutathione gel

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

krishnadevaraya college of dental sciences and Hospital

Bangalore, Kranataka, 562157, India

Location

MeSH Terms

Conditions

Vitiligo

Interventions

Percutaneous Collagen Induction

Condition Hierarchy (Ancestors)

HypopigmentationPigmentation DisordersSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsPhysical Therapy ModalitiesPuncturesRehabilitation

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Department of Periodontology

Study Record Dates

First Submitted

July 28, 2026

First Posted

August 5, 2026

Study Start

June 25, 2025

Primary Completion

December 28, 2025

Study Completion

July 28, 2026

Last Updated

August 5, 2026

Record last verified: 2026-08

Locations

IN(1)