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

NCT ID: NCT04710927

Last Updated: 2023-07-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-01
• Study Completion Date: 2021-11-30

Brief 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.

Detailed 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

Conditions

Molar Incisor Hypomineralization; Dental Caries; Hypomineralization of Enamel

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

High Viscosity GIC (HVGIC)

Group 1

Group Type: ACTIVE_COMPARATOR

High Viscosity Glass Ionomer Cement (HVGIC)

Intervention Type: DEVICE

The molar will be restored with HVGIC

Silver Diamine Fluoride (SDF) + HVGIC

Group 2

Group Type: EXPERIMENTAL

Silver Diamine Fluoride

Intervention Type: DEVICE

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

Papain based gel + SDF + HVGIC

Group 3

Group Type: EXPERIMENTAL

Papain-Based Gel

Intervention Type: DEVICE

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

Interventions

Silver Diamine Fluoride

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

Intervention Type: 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

Intervention Type: DEVICE

High Viscosity Glass Ionomer Cement (HVGIC)

The molar will be restored with HVGIC

Intervention Type: DEVICE

Other Intervention Names

Riva Star; Papacare Duo; Riva Self Cure HV

Eligibility Criteria

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)

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Malaya

OTHER

Sponsor Role: lead

Responsible Party

Dr Tengku Nurfarhana Nadirah Bt Tengku Hamzah

Lecturer in Paediatric Dentistry

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tengku Nurfarhana Bt Tengku Hamzah

Role: PRINCIPAL_INVESTIGATOR

University of Malaya

Locations

Faculty of Dentistry, University of Malaya

Kuala Lumpur, Kuala Lumpur, Malaysia

Countries

Malaysia

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

DF CD1912/0061/20155(P)

Identifier Type: -

Identifier Source: org_study_id