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NCT Number: NCT04710927

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

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.

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Key information

Conditions

Molar Incisor Hypomineralization Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dental Caries Dental Enamel Hypomineralization Developmental Defects of Enamel Hypomineralization of Enamel Molar Hypomineralization Stomatognathic Diseases Stomatognathic System Abnormalities Tooth Abnormalities Tooth Demineralization Tooth Diseases

Age range

5 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry, University of Malaya

Kuala Lumpur, 50603, Malaysia

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Silver diamine fluoride

Device

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

Other names: Riva Star

Papain-Based Gel

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

Other names: Papacare Duo

High Viscosity Glass Ionomer Cement (HVGIC)

Device

The molar will be restored with HVGIC

Other names: Riva Self Cure HV

Primary outcomes

  1. Clinical Outcome Based on Success After Intervention on MIH Affected Molar at 6 Months

    Time frame: 6 month

    Treated MIH affected molars must fulfilled all criteria for success in order to be reported as success. Criteria of 'Successful' on treated MIH affected molars include

    • Absence of pain related to the treated tooth/teeth
    • Absence of tenderness to percussion (TTP)
    • No evidence of swelling of supporting soft tissue or presence of a sinus tract
    • Absence of enamel breakdown and caries along margin of restoration
    • Scale 0 and 1 for Schiff Cold Air Sensitivity Scale

  2. Clinical Outcome Based on Success After Intervention on MIH Affected Molar at 12 Months

    Time frame: 12 month

    Treated MIH affected molars must fulfilled all criteria for success in order to be reported as successful. Criteria of 'Successful' on treated MIH affected molars include

    • Absence of pain related to the treated tooth/teeth
    • Absence of tenderness to percussion (TTP)
    • No evidence of swelling of supporting soft tissue or presence of a sinus tract
    • Absence of enamel breakdown and caries along margin of restoration
    • Scale 0 and 1 for Schiff Cold Air Sensitivity Scale

Sponsors and collaborators

Lead sponsor

University of Malaya

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Jan 15, 2021
Registry last updated
Jul 20, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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