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Silver Diamine Fluoride and Papain-Based Gel for Management of MIH-affected Molar in Paediatric Patients

NCT04710927 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2023-07-20

Study results available
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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.

Conditions

  • Molar Incisor Hypomineralization
  • Dental Caries
  • Hypomineralization of Enamel

Interventions

DEVICE

Silver Diamine Fluoride

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

DEVICE

Papain-Based Gel

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

DEVICE

High Viscosity Glass Ionomer Cement (HVGIC)

The molar will be restored with HVGIC

Sponsors & Collaborators

  • University of Malaya

    lead OTHER

Principal Investigators

  • Tengku Nurfarhana Bt Tengku Hamzah · University of Malaya

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
15 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-12-01
Primary Completion
2021-05-31
Completion
2021-11-30
FDA Device
Yes

Countries

  • Malaysia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04710927 on ClinicalTrials.gov