Effect of Glutathione vs KI in Reducing SDF Staining When Used in Treatment of Primary Carious Teeth

What Was Tested

This registered not phased trial tested Glutathione.

Although black staining is considered a drawback that is clinically observed following SDF application and is the main primary barrier for its use clinically .

Child's behaviour and cooperation cannot be controlled at a young age or in special health care needs cases.

Therefore, the best treatment modality will always be a simple, fast and painless procedure and SDF is the best solution for those cases.

It had three arms (groups): Silver Diamine Flouride (active comparator), Glutathione (experimental) and Potassium iodide (experimental).

Discoloration of primary carious teeth treated by SDF.

Discoloration rate of primary carious teeth treated by SDF + Glutathione.

Discoloration rate of primary carious teeth treated by SDF + KI.

The registry classes the interventions as drug.

More on the Plan

ECC is a multifactorial disease result from the interaction of different factors as cariogenic microorganisms, exposure to fermentable carbohydrates through inappropriate feeding habits.

It affects teeth that are less susceptible to caries.

The management of ECC is expensive, often requiring extensive restorative treatment such as the drill and fill technique and extraction of teeth at an early age.

Nowadays, non-invasive treatment for arresting untreated dental caries is becoming urgently needed.

Who Took Part

Enrollment: 60 planned participants were the target.

It was open to people of any sex aged from 3 years up to 5 years.

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

Examples of who could join: Aged 3 to 5 years, in good general health and medically free. The parents provided written informed consent. Carious primary teeth. Teeth are not pulpally involved.

The full record lists 6 inclusion and 8 exclusion criteria; among the exclusions: with a history of allergy to silver; unable to attend follow-up visits; refusal of participation.

How the Study Was Run

It was run as a randomized, parallel-group and double-blind study.

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 participants stayed in one arm throughout.

As a double-blind Glutathione study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant and outcomes assessor.

It started in 2021-05-01 with completion listed for 2021-08-01.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Colour assessment (time frame: 6 months).

It also tracked 2 secondary outcomes, for example Parenteral satisfaction.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Glutathione in 60 people.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Glutathione compound page, all human trials.