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OpenTrials
Completed

NCT Number: NCT07748507

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

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.

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Key information

Conditions

Gingiival Hyperpigmentation Hypopigmentation Pigmentation Disorders Skin Diseases Skin and Connective Tissue Diseases Vitiligo

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

krishnadevaraya college of dental sciences and Hospital

Bangalore, Kranataka, 562157, India

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Microneedling using Dermapen device

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

Microneedling with 0.5 % Glutathione gel

Other

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

Primary outcomes

  1. 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

  2. Assessment of pigment surface area using Image J analysis software

    Time frame: baseline, 1 month, 3 months, 6 months

Secondary outcomes

  1. 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

  2. patient reported pain or discomfort

    Time frame: at the time of treatment , 1 month

    using visual analog scale

Sponsors and collaborators

Lead sponsor

Krishnadevaraya College of Dental Sciences & Hospital

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Aug 5, 2026
Registry last updated
Aug 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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