N/A N=57 Randomized Single-blind Treatment

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

Molar Incisor Hypomineralization · Dental Caries · Hypomineralization of Enamel

Bottom Line

View on ClinicalTrials.gov: NCT04710927 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jul 2023

Primary outcome: Primary: Clinical Outcome Based on Success After Intervention on MIH Affected Molar at 6 Months — 17; 18; 17 number of Successful MIH affected molars

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Silver Diamine Fluoride (Device); Papain-Based Gel (Device); High Viscosity Glass Ionomer Cement (HVGIC) (Device)
Age: Pediatric · 5+ yrs
Sex: All
Sponsor: University of Malaya
Primary completion: May 2021

Outcome Measures

Outcome	Result	p-value
PRIMARY Clinical Outcome Based on Success After Intervention on MIH Affected Molar at 6 Months	17; 18; 17	—
PRIMARY Clinical Outcome Based on Success After Intervention on MIH Affected Molar at 12 Months	14; 13; 15	<0.05 sig

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.

Eligibility Criteria

Inclusion Criteria

Healthy with ability to comprehend instruction and perform oral hygiene care independently
Hypomineralised First Permanent Molar with:

2.1 Post Eruptive Breakdown (Code 3)

2.2 Atypical restoration (Code 4) which is unsatisfactory or with secondary caries that require replacement

2.3 Atypical caries (Code 5) with enamel breakdown

Exclusion Criteria

Patient with silver allergy
First Permanent Molar with:

2.1 Non-MIH defect

2.2 White, creamy demarcated yellow or brown opacities (Code 2)

2.3 Good satisfactory atypical restoration (Code 4)

2.4 Atypical caries (Code 5) with pulpal involvement -Irreversible pulpitis and pulpal necrosis

2.5 Extensive coronal breakdown (Code 7)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04710927). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.