Gingival Hyperpigmentation Treatment

What Was Tested

This registered phase 2 trial tested Glutathione for hyperparathyroidism.

It is a clinical study conducted to evaluate the effect of vitamin C and Glucathonine injection of pigmented gingival tissue versus surgical removal by scalpel.

It had two arms (groups): Arm1:(Vit C & glutathione injection) (experimental) and ATM 2: surgical depigmentation (active comparator).

The registry classes the interventions as drug and procedure.

More on the Plan

Gingival hyperpigmentation has been an aesthetic problem for many patients, which can definitely affect their psychosocial behavior.

Gingival hyperpigmentation is not a condition and can be defined as " a darker gingival color beyond what is normally expected".

Moreover, it can be attributed to multiple external or internal factors.

It may be physiological (excessive melanin deposition) or pathological (smoking).

Who Took Part

30 planned participants were the target.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Score0:absence of pigmentation. Score3:diffuse brown to black pigmentation,marginal,and attached. Physiologic gingival hyperpigmentation related to esthetic region. Well maintained oral hygiene and willing to undergo minor surgical procedures.

The full record lists 8 inclusion and 6 exclusion criteria; among the exclusions: pregnant and lactating mothers; usage of chlorhexidine or povidone iodine; local causes (smoking).

How the Study Was Run

Design: randomized, parallel-group and open-label.

Random assignment meant chance, not the researchers, decided who got Glutathione and who got the comparison, which limits bias.

The Glutathione group and the comparison group ran side by side rather than switching.

Everyone knew when Glutathione was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2025-08-01 with completion listed for 2027-01.

It ran at 1 site in Egypt.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Degree of gingival pigmentation by Takashi index (Hanioka et al., 2005) (time frame: baseline: before surgery/injection (day1), after 1 mon ,3 mon ,6 mon and 9 month). Degree of gingival pigmentation by Gingival pigmentation index (Kumar et al., 2013).

It also tracked 3 secondary outcomes, for example Pain score, Itching and Patient satisfaction.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Glutathione in 30 people with hyperparathyroidism.

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

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Glutathione compound page, Hyperparathyroidism research.