Trial Outcomes & Findings for Silver Diamine Fluoride and Papain-Based Gel for Management of MIH-affected Molar in Paediatric Patients (NCT NCT04710927)

Last Updated: 2023-07-20

Results Overview

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

Recruitment status

COMPLETED

Study phase

Target enrollment

38 participants

Primary outcome timeframe

6 month

Results posted on

2023-07-20

Participant Flow

Recruitment period : 1st December 2019 to 6th October 2020 Location: Paediatric Dental Clinic, Faculty of Dentistry, University of Malaya, Kuala Lumpur, Malaysia

For this study, Molar Incisor Hypomineralisation (MIH) affected molar was used as unit prior assignment to intervention groups. The reason for this, data collections were affected by the peak of Coronavirus disease (COVID-19) pandemic with movement control orders enforcement for months in Malaysia. Due to this problem, one participants may had one to four molars (teeth) affected with MIH and be assigned into more than 1 intervention groups. Total participants for this study was 38 participants.

Unit of analysis: number of MIH affected molars

Participant milestones

Participant milestones
Measure	High Viscosity Glass Ionomer Cement (HVGIC) (Group 1) High Viscosity Glass Ionomer Cement: The MIH affected molar will be restored with HVGIC	Silver Diamine Fluoride(SDF) + HVGIC (Group 2) Silver Diamine Fluoride(SDF): A single application of SDF 38% (Riva Star) on dry affected molar for 1 minute and immediately restored using HVGIC	Papain Based Gel + SDF + HVGIC (Group 3) 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
Overall Study STARTED	18 21	19 21	20 21
Overall Study 6 Months	15 18	16 17	16 17
Overall Study 12 Months	11 13	13 15	15 16
Overall Study COMPLETED	11 13	13 15	15 16
Overall Study NOT COMPLETED	7 8	6 6	5 5

Reasons for withdrawal

Reasons for withdrawal
Measure	High Viscosity Glass Ionomer Cement (HVGIC) (Group 1) High Viscosity Glass Ionomer Cement: The MIH affected molar will be restored with HVGIC	Silver Diamine Fluoride(SDF) + HVGIC (Group 2) Silver Diamine Fluoride(SDF): A single application of SDF 38% (Riva Star) on dry affected molar for 1 minute and immediately restored using HVGIC	Papain Based Gel + SDF + HVGIC (Group 3) 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
Overall Study Lost to Follow-up	7	6	5

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	High Viscosity GIC (HVGIC) n=21 MIH affected molars High Viscosity GIC High Viscosity Glass Ionomer Cement: The molar will be restored with HVGIC	Silver Diamine Fluoride (SDF) + HVGIC n=21 MIH affected molars SDF and High Viscosity GIC Silver Diamine Fluoride: A single application of SDF 38% (Riva Star) on dry affected molar for 1 minute and immediately restored using HVGIC	Papain Based Gel + SDF + HVGIC n=21 MIH affected molars SDF, Papain-Based Gel and High Viscosity GIC 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	Total n=63 MIH affected molars Total of all reporting groups
Age, Customized	10.1 years STANDARD_DEVIATION 2.80 • n=5 Participants	7.9 years STANDARD_DEVIATION 1.50 • n=7 Participants	9.2 years STANDARD_DEVIATION 2.44 • n=5 Participants	9.2 years STANDARD_DEVIATION 2.43 • n=4 Participants
Sex/Gender, Customized Male	9 participants n=5 Participants	9 participants n=7 Participants	10 participants n=5 Participants	28 participants n=4 Participants
Sex/Gender, Customized Female	12 participants n=5 Participants	12 participants n=7 Participants	11 participants n=5 Participants	35 participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	18 Participants n=5 Participants	19 Participants n=7 Participants	20 Participants n=5 Participants	57 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
MIH affected molars	18 Participants n=5 Participants	19 Participants n=7 Participants	20 Participants n=5 Participants	57 Participants n=4 Participants

PRIMARY outcome

Timeframe: 6 month

Population: Descriptive analysis of frequency was used. MIH affected molars represents as participants. This is because one participants may have more than 1 tooth assigned into one or more intervention groups.

Outcome measures

Outcome measures
Measure	High Viscosity GIC (HVGIC) n=18 MIH affected molars High Viscosity GIC High Viscosity Glass Ionomer Cement: The molar will be restored with HVGIC	Silver Diamine Fluoride (SDF) + HVGIC n=18 MIH affected molars SDF and High Viscosity GIC Silver Diamine Fluoride: A single application of SDF 38% (Riva Star) on dry affected molar for 1 minute and immediately restored using HVGIC	Papain Based Gel + SDF + HVGIC n=17 MIH affected molars 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
Clinical Outcome Based on Success After Intervention on MIH Affected Molar at 6 Months	17 number of Successful MIH affected molars	18 number of Successful MIH affected molars	17 number of Successful MIH affected molars

PRIMARY outcome

Timeframe: 12 month

Population: Descriptive analysis of frequency was used. MIH affected molars represent as participants in this analysis. This is because one participants may have more than 1 tooth assigned into one or more intervention groups.

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

Outcome measures

Outcome measures
Measure	High Viscosity GIC (HVGIC) n=14 MIH affected molars High Viscosity GIC High Viscosity Glass Ionomer Cement: The molar will be restored with HVGIC	Silver Diamine Fluoride (SDF) + HVGIC n=13 MIH affected molars SDF and High Viscosity GIC Silver Diamine Fluoride: A single application of SDF 38% (Riva Star) on dry affected molar for 1 minute and immediately restored using HVGIC	Papain Based Gel + SDF + HVGIC n=15 MIH affected molars 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
Clinical Outcome Based on Success After Intervention on MIH Affected Molar at 12 Months	14 number of successful MIH affected molars	13 number of successful MIH affected molars	15 number of successful MIH affected molars

Adverse Events

High Viscosity Glass Ionomer Cement (HVGIC)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Silver Diamine Fluoride (SDF) + HVGIC

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Papain Based Gel + SDF + HVGIC

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr Tengku Nurfarhana Nadirah Tengku Hamzah

University Malaya Kuala Lumpur, Malaysia

Phone: 0379674802

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place