Molar Incisor HypomineralizationNCT04710927

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

A study testing Silver Diamine Fluoride, Papain-Based Gel and High Viscosity Glass Ionomer Cement (HVGIC) in people with Molar Incisor Hypomineralization and Dental Caries, run by University of Malaya at 1 site in Malaysia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 5 to 15 yearsHealthy volunteers can take part
Conditions the study is for: Molar Incisor Hypomineralization, Dental Caries, Hypomineralization of Enamel
What is being tested?: Silver Diamine Fluoride, Papain-Based Gel and High Viscosity Glass Ionomer Cement (HVGIC)
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 38 participants
Where: 1 siteMalaysia
Study dates: 1 Dec 2019to 30 Nov 2021
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 5 to 15 years
All sexes
Healthy volunteers accepted
Child

Who may be able to join

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

Who cannot join

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)

Trial locations and contacts

1 site in 1 country.

Malaysia1 site

Faculty of Dentistry, University of Malaya
Kuala Lumpur, Kuala Lumpur, 50603

Other trials in Malaysia

About this study

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

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.

Read the 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

Conditions: Molar Incisor Hypomineralization, Dental Caries, Hypomineralization of Enamel
Being tested: Silver Diamine Fluoride, Papain-Based Gel, High Viscosity Glass Ionomer Cement (HVGIC)
Keywords: molar incisor hypomineralization, silver diamine fluoride, deproteinizing agent
Medical subject headings: Molar Hypomineralization, Dental Caries, Dental Enamel Hypomineralization

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Silver Diamine FluorideDevice
Also called Riva Star
A single application of SDF 38% (Riva Star) on dry affected molar for 1 minute and immediately restored using HVGIC
Papain-Based GelDevice
Also called Papacare Duo
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
High Viscosity Glass Ionomer Cement (HVGIC)Device
Also called Riva Self Cure HV
The molar will be restored with HVGIC

Study groups in NCT04710927
Study group	Role	What they receive
High Viscosity GIC (HVGIC)	Active comparator	Group 1 Receives: Device: High Viscosity Glass Ionomer Cement (HVGIC)
Silver Diamine Fluoride (SDF) + HVGIC	Experimental	Group 2 Receives: Device: Silver Diamine Fluoride
Papain based gel + SDF + HVGIC	Experimental	Group 3 Receives: Device: Papain-Based Gel

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 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
Measured: 12 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Dec 201930 Nov 2021

First posted15 Jan 2021
Study start1 Dec 2019
Primary completion31 May 2021
Study completion30 Nov 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Molar Incisor HypomineralizationStudies of the same condition, open and under way.
More trials run by University of MalayaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 38 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04710927
Sponsor's protocol ID: DF CD1912/0061/20155(P)
Status last verified: Jun 2023
First submitted: 27 Dec 2020
Last updated: 20 Jul 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruiting
Computer-aided Design/Computer-aided Manufacturing for Mild to Moderate Molar Incisor Hypomineralization Treatment
Molar Incisor Hypomineralization
Not yet recruiting
Clinical Performance of Glass Hybrid and Alkasite Restorative Systems in MIH-Affected Permanent First Molars
Molar-Incisor Hypomineralization (MIH)
Recruiting
Nanohydroxyapatite Versus Sodium Fluoride Varnish in Remineralizing MIH Anterior Teeth
Fluoride Varnishes, Molar Incisor Hypomineralisation
Recruiting
Molar-Incisor Hypomineralization and Resin Infiltration
Molar Incisor Hypomineralization
Active, not recruiting
Pain Assessment Governing Partial or Full Pulpotomy of Immature Molars With Irreversible Pulpitis in Molar Incisor Hypomineralization
Molar Incisor Hypomineralisation, Irreversible Pulpitis

All Molar Incisor Hypomineralization trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT04710927
Acronym / sponsor ID: DF CD1912/0061/20155(P)
Conditions: Molar Incisor Hypomineralization, Dental Caries, Hypomineralization of Enamel
Keywords: molar incisor hypomineralization, silver diamine fluoride, deproteinizing agent
Study type: Interventional
Recruitment status: Completed
Enrolment: 38 participants (actual)
Lead sponsor: University of MalayaUniversity, hospital or other
Study start: 1 Dec 2019 (actual)
Primary completion: 31 May 2021 (actual)
Study completion: 30 Nov 2021 (actual)
First posted: 15 Jan 2021 (actual)
Results: Posted 20 Jul 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 3

Arm	Type	Receives
High Viscosity GIC (HVGIC)	Active comparator	Device: High Viscosity Glass Ionomer Cement (HVGIC)Group 1
Silver Diamine Fluoride (SDF) + HVGIC	Experimental	Device: Silver Diamine FluorideGroup 2
Papain based gel + SDF + HVGIC	Experimental	Device: Papain-Based GelGroup 3

Who may qualify

Ages: 5 to 15 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (5 listed)

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

Key exclusion criteria (7 listed)

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)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Silver Diamine FluorideAlso: Riva StarA single application of SDF 38% (Riva Star) on dry affected molar for 1 minute and immediately restored using HVGIC	Device	Silver Diamine Fluoride (SDF) + HVGIC
Papain-Based GelAlso: Papacare DuoPapain 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	Device	Papain based gel + SDF + HVGIC
High Viscosity Glass Ionomer Cement (HVGIC)Also: Riva Self Cure HVThe molar will be restored with HVGIC	Device	High Viscosity GIC (HVGIC)

Primary outcome

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
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

Results and safety

Results posted to the registry on 20 Jul 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
High Viscosity Glass Ionomer Cement (HVGIC) (Group 1)	18	11
Silver Diamine Fluoride(SDF) + HVGIC (Group 2)	19	13
Papain Based Gel + SDF + HVGIC (Group 3)	20	15

Primary outcome: Clinical Outcome Based on Success After Intervention on MIH Affected Molar at 6 Months

Time frame: 6 month. Number. Unit: number of Successful MIH affected molars

Measure	High Viscosity GIC (HVGIC) n = 15	Silver Diamine Fluoride (SDF) + HVGIC n = 16	Papain Based Gel + SDF + HVGIC n = 16
Value	17	18	17

Population analysed: 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.

Primary outcome: Clinical Outcome Based on Success After Intervention on MIH Affected Molar at 12 Months

Time frame: 12 month. Number. Unit: number of successful MIH affected molars

Measure	High Viscosity GIC (HVGIC) n = 12	Silver Diamine Fluoride (SDF ) + HVGIC n = 11	Papain Based Gel + SDF + HVGIC n = 14
Value	14	13	15

High Viscosity GIC (HVGIC) vs Silver Diamine Fluoride (SDF ) + HVGIC vs Papain Based Gel + SDF + HVGIC: Odds Ratio (OR): 0.7, p <0.05, t-test, 2 sided
High Viscosity GIC (HVGIC) vs Silver Diamine Fluoride (SDF ) + HVGIC vs Papain Based Gel + SDF + HVGIC: p <0.05, t-test, 2 sided

Population analysed: 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.

Adverse events

Time frame: through study completion with an average of 1 year.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
High Viscosity Glass Ionomer Cement (HVGIC)	0 of 18 (0%)	0 of 18 (0%)	0 of 18
Silver Diamine Fluoride (SDF) + HVGIC	0 of 19 (0%)	0 of 19 (0%)	0 of 19
Papain Based Gel + SDF + HVGIC	0 of 20 (0%)	0 of 20 (0%)	0 of 20

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Molar Incisor Hypomineralization

Active, not recruiting
Computer-aided Design/Computer-aided Manufacturing for Mild to Moderate Molar Incisor Hypomineralization Treatment
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Clinical Performance of Glass Hybrid and Alkasite Restorative Systems in MIH-Affected Permanent First Molars
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Nanohydroxyapatite Versus Sodium Fluoride Varnish in Remineralizing MIH Anterior Teeth
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Tengku Nurfarhana Bt Tengku Hamzah principal investigator

University of Malaya

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Jul 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinical Outcome Based on Success After Intervention on MIH Affected Molar at 6 Months (time frame: 6 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04710927.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2023.