CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 38 enrolled
Drug / intervention
Silver Diamine Fluoride +2 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04710927
NCT04710927N/ACompleted

The Use of Silver Diamine Fluoride and Papain-Based Gel for Management of MIH-affected Molar in Paediatric Patients: A Randomised Controlled Trial

University of Malaya·interventional·Posted Jan 15, 2021·Updated Jul 20, 2023

In Brief

A clinical study evaluating Silver Diamine Fluoride, Papain-Based Gel, and 1 other intervention for Molar Incisor Hypomineralization and 2 related conditions. Completed, enrolled 38 participants across 1 site.

Detailed Summary

Molar incisor hypomineralization (MIH) is a developmental defect of enamel affecting the first permanent molar and frequently the incisors with a prevalence of 16-16.9% in Malaysia. They presented with many problems such as hypersensitivity, increase susceptibility of caries, need for recurrent complex dental treatment, and difficulty to achieve pain control. Silver Diamine Fluoride is a new form of topical fluoride that has been extensively used and recommended for the management of caries in children and adolescents. The influence of organic material removal from artificial dentine lesions by means of surface pre-treatment with deproteinizing agent show favoring result of its use on subsequent remineralization with and without fluoride. The purpose of this trial is to study the clinical outcome of SDF and papain based gel on hypomineralized teeth restored with HVGIC.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesMalaysia
Collaborators--

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedJan 15, 2021
Enrollment StartDec 1, 2019
Primary CompletionMay 31, 2021
Study CompletionNov 30, 2021
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 5.5 years ago

Interventions

Silver Diamine Fluoridedevice

A single application of SDF 38% (Riva Star) on dry affected molar for 1 minute and immediately restored using HVGIC

Papain-Based Geldevice

Papain based Gel (Papacare Duo) will be applied to the MIH affected molar for 60 seconds and repeated if required. The molar will be treated with SDF and restored using HVGIC

High Viscosity Glass Ionomer Cement (HVGIC)device

The molar will be restored with HVGIC