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

University of Malaya

Status: Completed

Conditions: Dental Caries; Hypomineralization of Enamel; Molar Incisor Hypomineralization

Treatments: Device: Papain-Based Gel; Device: Silver Diamine Fluoride; Device: High Viscosity Glass Ionomer Cement (HVGIC)

Study type: Interventional

Funder types: Other

Identifiers

NCT04710927

DF CD1912/0061/20155(P)

Details and patient eligibility

About

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.

Full description

This is a three-arm parallel randomized controlled trial and will be performed in participants between the age of 5 to 15 years presented with hypomineralised molar of MIH in origin.

Clinical assessment, radiograph, and photographs will be taken for assessment. Patients that fulfilled the inclusion criteria will be invited to the study. After that, the patient will be explained and a Patient Information Sheet (PIS) will be given. Once consent obtained and the patient randomly allocated for the treatment group, treatment will be done as below:

For group 1, any caries if present will be removed using a hand instrument. The tooth then will be filled with High Viscous Glass Ionomer Cement (HVGIC) following the manufacturer's instruction. If the participant is assigned to group 2, after caries has been removed using a hand instrument, silver diamine fluoride (SDF) will be applied for 1 minute on the affected area prior to restoration with HVGIC following the manufacturer's instruction. If the participant is assigned to group 3, papain-based gel (Papacare Duo) will be applied as a deproteinizing agent, caries will be removed using a hand instrument if present. Then, silver diamine fluoride will be applied for 1 minute on the affected area prior to restoration with HVGIC following the manufacturer's instruction.

The patient will be followed up after 6 and 12 months. The teeth and restoration will be assessed clinically by an assessor that is not involved in the provision of treatment. Sign and symptom of pain, tenderness to percussion, presence of swelling or fistula, the scale of sensitivity using Schiff Cold Air Sensitivity Scale (SCASS), quality if restorative assessment using Atraumatic Restorative Treatment (ART) Index

Enrollment: 38 patients

Sex: All

Ages: 5 to 15 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Healthy with ability to comprehend instruction and perform oral hygiene care independently
2. 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

1. Patient with silver allergy
2. 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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38 participants in 3 patient groups

High Viscosity GIC (HVGIC)

Active Comparator group

Description:

Group 1

Treatment:

Device: High Viscosity Glass Ionomer Cement (HVGIC)

Silver Diamine Fluoride (SDF) + HVGIC

Experimental group

Description:

Group 2

Treatment:

Device: Silver Diamine Fluoride

Papain based gel + SDF + HVGIC

Experimental group

Description:

Group 3

Treatment:

Device: Papain-Based Gel