Silver Diamine Fluoride and Papain-Based Gel for Management of MIH-affected Molar in Paediatric Patients
Condition: Molar Incisor Hypomineralization; Dental Caries; Hypomineralization of Enamel
MeSH terms: Dental Caries; Molar Hypomineralization; Dental Enamel Hypoplasia
Study type: Interventional

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
    

Intervention name(s): Silver Diamine Fluoride; Papain-Based Gel; High Viscosity Glass Ionomer Cement (HVGIC)
Intervention type(s): Device; Device; Device
Intervention description(s): A single application of SDF 38% (Riva Star) on dry affected molar for 1 minute and immediately restored using HVGIC; 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; The molar will be restored with HVGIC
Other intervention name(s): Riva Star; Papacare Duo; Riva Self Cure HV
Intervention MeSH terms: Fluorides
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: molar incisor hypomineralization; silver diamine fluoride; deproteinizing agent