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

June 29, 2023 updated by: Dr Tengku Nurfarhana Nadirah Bt Tengku Hamzah, University of Malaya

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

38

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Malaysia
    • Wilayah Persekutuan Kuala Lumpur
      • Kuala Lumpur, Wilayah Persekutuan Kuala Lumpur, Malaysia, 50603
        • Faculty of Dentistry, University of Malaya

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 15 years (Child)

Accepts Healthy Volunteers

Yes

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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

  1. Absence of pain related to the treated tooth/teeth
  2. Absence of tenderness to percussion (TTP)
  3. No evidence of swelling of supporting soft tissue or presence of a sinus tract
  4. Absence of enamel breakdown and caries along margin of restoration
  5. 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
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

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Radiographic outcome of the MIH affected molar at 6 month
Time Frame: 6 month

Radiographic findings of affected molar after 6 month

Findings recorded include

  1. Absence/Presence of radiographic evidence of new caries lesion
  2. Absence/Presence of radiographic evidence of pulp involvement
  3. Absence/Presence of radiographic evidence of pathological root resorption
  4. Absence/Presence of radiographic evidence of pathology at bifurcation/periapical
6 month
Radiographic outcome of the MIH affected molar at 12 month
Time Frame: 12 month

Radiographic findings of affected molar after 12 month

Findings recorded include

  1. Absence/Presence of radiographic evidence of new caries lesion
  2. Absence/Presence of radiographic evidence of pulp involvement
  3. Absence/Presence of radiographic evidence of pathological root resorption
  4. Absence/Presence of radiographic evidence of pathology at bifurcation/periapical
12 month

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of HVGIC Restoration at 6 month
Time Frame: 6 month

The quality of restoration will be assessed using ART Index

Criteria for Satisfactory Restoration includes restoration that is:

Code 0 - Present and satisfactory restoration (Code 0)

Code 1 - Present, slight deficiency at cavity margin of less than 0.5 mm

Criteria for Unsatisfactory restoration include those with;

Code 2 - Present, deficiency at cavity margin of 0.5 mm or more Code 3 - Present, fracture in restoration Code 4 - Present, fracture in tooth Code 5 - Present, overextension of approximal margin of 0.5 mm or more Code 6 - Not present, most or all of restoration missing
6 month
Quality of HVGIC Restoration at 12 month
Time Frame: 12 month

The quality of restoration will be assessed using ART Index

Criteria for Satisfactory Restoration includes restoration that is:

Code 0 - Present and satisfactory restoration (Code 0)

Code 1 - Present, slight deficiency at cavity margin of less than 0.5 mm

Criteria for Unsatisfactory restoration include those with;

Code 2 - Present, deficiency at cavity margin of 0.5 mm or more Code 3 - Present, fracture in restoration Code 4 - Present, fracture in tooth Code 5 - Present, overextension of approximal margin of 0.5 mm or more Code 6 - Not present, most or all of restoration missing
12 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Malaya

Collaborators

University Malaya

Investigators

  • Principal Investigator: Tengku Nurfarhana Bt Tengku Hamzah, University of Malaya

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2019

Primary Completion (Actual)

May 31, 2021

Study Completion (Actual)

November 30, 2021

Study Registration Dates

First Submitted

December 27, 2020

First Submitted That Met QC Criteria

January 12, 2021

First Posted (Actual)

January 15, 2021

Study Record Updates

Last Update Posted (Actual)

July 20, 2023

Last Update Submitted That Met QC Criteria

June 29, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DF CD1912/0061/20155(P)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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