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

Primary Purpose

Molar Incisor Hypomineralization, Dental Caries, Hypomineralization of Enamel

Status
Completed
Phase
Not Applicable
Locations
Malaysia
Study Type
Interventional
Intervention
Silver Diamine Fluoride
Papain-Based Gel
High Viscosity Glass Ionomer Cement (HVGIC)
Sponsored by
University of Malaya
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Molar Incisor Hypomineralization focused on measuring molar incisor hypomineralization, silver diamine fluoride, deproteinizing agent

Eligibility Criteria

5 Years - 15 Years (Child)All SexesAccepts Healthy Volunteers

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)

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)

Sites / Locations

  • Faculty of Dentistry, University of Malaya

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

High Viscosity GIC (HVGIC)

Silver Diamine Fluoride (SDF) + HVGIC

Papain based gel + SDF + HVGIC

Arm Description

Group 1

Group 2

Group 3

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

Full Information

First Posted
December 27, 2020
Last Updated
June 29, 2023
Sponsor
University of Malaya
Collaborators
University Malaya
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1. Study Identification

Unique Protocol Identification Number
NCT04710927
Brief Title
Silver Diamine Fluoride and Papain-Based Gel for Management of MIH-affected Molar in Paediatric Patients
Official Title
The Use of Silver Diamine Fluoride and Papain-Based Gel for Management of MIH-affected Molar in Paediatric Patients: A Randomised Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
December 1, 2019 (Actual)
Primary Completion Date
May 31, 2021 (Actual)
Study Completion Date
November 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Malaya
Collaborators
University Malaya

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Molar Incisor Hypomineralization, Dental Caries, Hypomineralization of Enamel
Keywords
molar incisor hypomineralization, silver diamine fluoride, deproteinizing agent

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
Participant were not informed regarding intervention given
Allocation
Randomized
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
High Viscosity GIC (HVGIC)
Arm Type
Active Comparator
Arm Description
Group 1
Arm Title
Silver Diamine Fluoride (SDF) + HVGIC
Arm Type
Experimental
Arm Description
Group 2
Arm Title
Papain based gel + SDF + HVGIC
Arm Type
Experimental
Arm Description
Group 3
Intervention Type
Device
Intervention Name(s)
Silver Diamine Fluoride
Other Intervention Name(s)
Riva Star
Intervention Description
A single application of SDF 38% (Riva Star) on dry affected molar for 1 minute and immediately restored using HVGIC
Intervention Type
Device
Intervention Name(s)
Papain-Based Gel
Other Intervention Name(s)
Papacare Duo
Intervention Description
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
Intervention Name(s)
High Viscosity Glass Ionomer Cement (HVGIC)
Other Intervention Name(s)
Riva Self Cure HV
Intervention Description
The molar will be restored with HVGIC
Primary Outcome Measure Information:
Title
Clinical Outcome Based on Success After Intervention on MIH Affected Molar at 6 Months
Description
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
Time Frame
6 month
Title
Clinical Outcome Based on Success After Intervention on MIH Affected Molar at 12 Months
Description
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
Time Frame
12 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tengku Nurfarhana Bt Tengku Hamzah
Organizational Affiliation
University of Malaya
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Dentistry, University of Malaya
City
Kuala Lumpur
State/Province
Wilayah Persekutuan Kuala Lumpur
ZIP/Postal Code
50603
Country
Malaysia

12. IPD Sharing Statement

Plan to Share IPD
No

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

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