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

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Molar Incisor Hypomineralization, Dental Caries, Hypomineralization of Enamel

Intervention / Treatment
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* Device: Silver Diamine Fluoride
* Device: Papain-Based Gel
* Device: High Viscosity Glass Ionomer Cement (HVGIC)


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: High Viscosity GIC (HVGIC)<br>Group 1 | Device: High Viscosity Glass Ionomer Cement (HVGIC)<br>* The molar will be restored with HVGIC<br>* Other names: Riva Self Cure HV;|
| Experimental: Silver Diamine Fluoride (SDF) + HVGIC<br>Group 2 | Device: Silver Diamine Fluoride<br>* A single application of SDF 38% (Riva Star) on dry affected molar for 1 minute and immediately restored using HVGIC<br>* Other names: Riva Star;|
| Experimental: Papain based gel + SDF + HVGIC<br>Group 3 | Device: Papain-Based Gel<br>* 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<br>* Other names: Papacare Duo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Outcome Based on Success After Intervention on MIH Affected Molar at 6 Months | 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 | 6 month | 
| Clinical Outcome Based on Success After Intervention on MIH Affected Molar at 12 Months | 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 | 12 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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molar incisor hypomineralization, silver diamine fluoride, deproteinizing agent