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

NCT04710927 | Completed Results FDA Device

• 1 other identifier: DF CD1912/0061/20155(P)
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Molar Incisor Hypomineralization; Dental Caries; Hypomineralization of Enamel

Keywords

molar incisor hypomineralization; silver diamine fluoride; deproteinizing agent

Outcome Measures

Primary Outcomes (2)

• 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 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

  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

Study Arms (3)

High Viscosity GIC (HVGIC)

ACTIVE COMPARATOR

Group 1

Device: High Viscosity Glass Ionomer Cement (HVGIC)

Silver Diamine Fluoride (SDF) + HVGIC

EXPERIMENTAL

Group 2

Device: Silver Diamine Fluoride

Papain based gel + SDF + HVGIC

EXPERIMENTAL

Group 3

Device: Papain-Based Gel

Interventions

Silver Diamine Fluoride DEVICE

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

Also known as: Riva Star

Silver Diamine Fluoride (SDF) + HVGIC

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

Also known as: Papacare Duo

Papain based gel + SDF + HVGIC

High Viscosity Glass Ionomer Cement (HVGIC) DEVICE

The molar will be restored with HVGIC

Also known as: Riva Self Cure HV

High Viscosity GIC (HVGIC)

Eligibility Criteria

• Age: 5 Years - 15 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Healthy with ability to comprehend instruction and perform oral hygiene care independently
• Hypomineralised First Permanent Molar with:
• Post Eruptive Breakdown (Code 3)
• Atypical restoration (Code 4) which is unsatisfactory or with secondary caries that require replacement
• Atypical caries (Code 5) with enamel breakdown

You may not qualify if:

• Patient with silver allergy
• First Permanent Molar with:
• Non-MIH defect
• White, creamy demarcated yellow or brown opacities (Code 2)
• Good satisfactory atypical restoration (Code 4)
• Atypical caries (Code 5) with pulpal involvement -Irreversible pulpitis and pulpal necrosis
• Extensive coronal breakdown (Code 7)

Sponsors & Collaborators

• University of Malaya: lead

Study Sites (1)

Faculty of Dentistry, University of Malaya

Kuala Lumpur, Kuala Lumpur, 50603, Malaysia

Location

MeSH Terms

Conditions

Molar Hypomineralization; Dental Caries; Dental Enamel Hypomineralization

Condition Hierarchy (Ancestors)

Developmental Defects of Enamel; Tooth Abnormalities; Stomatognathic System Abnormalities; Stomatognathic Diseases; Tooth Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Tooth Demineralization

Limitations and Caveats

Small sample size of participants had led the result of this study to be interpreted with caution by other researchers. Ideal randomisation process cannot be fulfilled and MIH affected molars has been used as a unit for analyses. Thus, one participant may be assigned to more than one intervention groups. This situation pose a challenge to researcher as if one participant lost to follow up it will affect the number of unit/data to be analysed for each intervention groups.

Results Point of Contact

• Title: Dr Tengku Nurfarhana Nadirah Tengku Hamzah
• Organization: University Malaya Kuala Lumpur, Malaysia

tengkunurfarhana@um.edu.my

0379674802

Study Officials

• Tengku Nurfarhana Bt Tengku Hamzah

  University of Malaya

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participant were not informed regarding intervention given
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer in Paediatric Dentistry

Study Record Dates

• First Submitted: December 27, 2020
• First Posted: January 15, 2021
• Study Start: December 1, 2019
• Primary Completion: May 31, 2021
• Study Completion: November 30, 2021
• Last Updated: July 20, 2023
• Results First Posted: July 20, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)