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

What Was Tested

In this not phased trial, researchers set out to test Glutathione for hyperparathyroidism.

It had two arms (groups): Microneedling using Dermapen device (experimental) and one (experimental).

The registry classes the interventions as device and other.

More on the Plan

Various treatment modalities for depigmentation has been used over the decades.

In this study 15 patients meeting the eligibility criteria has been randomly assigned to either of the arms.

Who Took Part

Enrollment: 15 actual participants took part.

It was open to people of any sex aged from 18 years up to 45 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 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.

The full record lists 3 inclusion and 4 exclusion criteria; among the exclusions: 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.

How the Study Was Run

Design: randomized, parallel-group and double-blind.

Because people in this Glutathione study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Groups ran in parallel: each of the hyperparathyroidism participants stayed in one arm throughout.

Neither the hyperparathyroidism participants nor the staff measuring them knew who was on Glutathione, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant and outcomes assessor.

It started in 2025-06-25 with completion listed for 2025-12-28.

It ran at 1 site in India.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Assessment of Gingival pigmentation using SEMPI index (time frame: 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).

It also tracked 2 secondary outcomes, for example Rate of repigmentation and patient reported pain or discomfort.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Glutathione in 15 people with hyperparathyroidism.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Glutathione compound page, Hyperparathyroidism research.