Ignite Creation Date:
2025-12-25 @ 5:19 AM
Ignite Modification Date:
2025-12-26 @ 4:27 AM
Study NCT ID:
NCT04710927
Status:
COMPLETED
Last Update Posted:
2023-07-20
First Post:
2020-12-27
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Silver Diamine Fluoride and Papain-Based Gel for Management of MIH-affected Molar in Paediatric Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2023-04-12', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D000094604', 'term': 'Molar Hypomineralization'}, {'id': 'D003731', 'term': 'Dental Caries'}, {'id': 'D000094603', 'term': 'Dental Enamel Hypomineralization'}], 'ancestors': [{'id': 'D000094602', 'term': 'Developmental Defects of Enamel'}, {'id': 'D014071', 'term': 'Tooth Abnormalities'}, {'id': 'D018640', 'term': 'Stomatognathic System Abnormalities'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D017001', 'term': 'Tooth Demineralization'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'tengkunurfarhana@um.edu.my', 'phone': '0379674802', 'title': 'Dr Tengku Nurfarhana Nadirah Tengku Hamzah', 'phoneExt': '4865', 'organization': 'University Malaya Kuala Lumpur, Malaysia'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': '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.'}}, 'adverseEventsModule': {'timeFrame': 'through study completion with an average of 1 year.', 'eventGroups': [{'id': 'EG000', 'title': 'High Viscosity Glass Ionomer Cement (HVGIC)', 'description': 'High Viscosity Glass Ionomer Cement (HVGIC): The MIH affected molar will be restored with HVGIC', 'otherNumAtRisk': 18, 'deathsNumAtRisk': 18, 'otherNumAffected': 0, 'seriousNumAtRisk': 18, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Silver Diamine Fluoride (SDF) + HVGIC', 'description': 'Silver Diamine Fluoride: A single application of SDF 38% (Riva Star) on dry affected molar for 1 minute and immediately restored using HVGIC', 'otherNumAtRisk': 19, 'deathsNumAtRisk': 19, 'otherNumAffected': 0, 'seriousNumAtRisk': 19, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Papain Based Gel + SDF + HVGIC', 'description': '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', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 0, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Clinical Outcome Based on Success After Intervention on MIH Affected Molar at 6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}]}, {'units': 'MIH affected molars', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'High Viscosity GIC (HVGIC)', 'description': 'High Viscosity GIC\n\nHigh Viscosity Glass Ionomer Cement: The molar will be restored with HVGIC'}, {'id': 'OG001', 'title': 'Silver Diamine Fluoride (SDF) + HVGIC', 'description': 'SDF and High Viscosity GIC\n\nSilver Diamine Fluoride: A single application of SDF 38% (Riva Star) on dry affected molar for 1 minute and immediately restored using HVGIC'}, {'id': 'OG002', 'title': 'Papain Based Gel + SDF + HVGIC', 'description': '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'}], 'classes': [{'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 month', '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\n\n1. Absence of pain related to the treated tooth/teeth\n2. Absence of tenderness to percussion (TTP)\n3. No evidence of swelling of supporting soft tissue or presence of a sinus tract\n4. Absence of enamel breakdown and caries along margin of restoration\n5. Scale 0 and 1 for Schiff Cold Air Sensitivity Scale", 'unitOfMeasure': 'number of Successful MIH affected molars', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'MIH affected molars', 'denomUnitsSelected': 'MIH affected molars', 'populationDescription': '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.'}, {'type': 'PRIMARY', 'title': 'Clinical Outcome Based on Success After Intervention on MIH Affected Molar at 12 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}, {'units': 'MIH affected molars', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'High Viscosity GIC (HVGIC)', 'description': 'High Viscosity GIC\n\nHigh Viscosity Glass Ionomer Cement: The molar will be restored with HVGIC'}, {'id': 'OG001', 'title': 'Silver Diamine Fluoride (SDF ) + HVGIC', 'description': 'Silver Diamine Fluoride: A single application of SDF 38% (Riva Star) on dry affected molar for 1 minute and immediately restored using HVGIC'}, {'id': 'OG002', 'title': 'Papain Based Gel + SDF + HVGIC', 'description': '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'}], 'classes': [{'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.7', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'pValue': '<0.05', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': '12 month', '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\n\n1. Absence of pain related to the treated tooth/teeth\n2. Absence of tenderness to percussion (TTP)\n3. No evidence of swelling of supporting soft tissue or presence of a sinus tract\n4. Absence of enamel breakdown and caries along margin of restoration\n5. Scale 0 and 1 for Schiff Cold Air Sensitivity Scale", 'unitOfMeasure': 'number of successful MIH affected molars', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'MIH affected molars', 'denomUnitsSelected': 'MIH affected molars', 'populationDescription': '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.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'High Viscosity Glass Ionomer Cement (HVGIC) (Group 1)', 'description': 'High Viscosity Glass Ionomer Cement: The MIH affected molar will be restored with HVGIC'}, {'id': 'FG001', 'title': 'Silver Diamine Fluoride(SDF) + HVGIC (Group 2)', 'description': 'Silver Diamine Fluoride(SDF): A single application of SDF 38% (Riva Star) on dry affected molar for 1 minute and immediately restored using HVGIC'}, {'id': 'FG002', 'title': 'Papain Based Gel + SDF + HVGIC (Group 3)', 'description': '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'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Total of 10 participants in treatment arm/group 1 had more than 1 treatment interventions (6 participants had 2 treatment interventions and 4 participants with 3 treatment interventions). Only 8 participants had 1 treatment intervention. However, 3 participants from a total of 18 participants had 2 teeth assigned into treatment arm/group 1 regardless having assigned to single or more than 1 treatment group (2 and 3 treatment interventions).', 'groupId': 'FG000', 'numUnits': '21', 'numSubjects': '18'}, {'comment': 'Total of 12 participants in treatment arm/group 2 had more than 1 treatment interventions (8 participants had 2 treatment interventions and 4 participants with all 3 treatment interventions). Only 7 participants had 1 treatment intervention. However, 2 out of 8 participants from 2 treatment interventions had 2 teeth assigned for treatment arm/group 2.', 'groupId': 'FG001', 'numUnits': '21', 'numSubjects': '19'}, {'comment': 'Total of 11 participants in treatment arm/group 3 had more than 1 treatment interventions (7 participants had 2 treatment interventions and 4 participants with 3 treatment interventions). Only 9 participants had 1 treatment intervention. However, 1 out of 4 participants from 3 treatment interventions had 2 teeth assigned for treatment arm/group 3.', 'groupId': 'FG002', 'numUnits': '21', 'numSubjects': '20'}]}, {'type': '6 Months', 'achievements': [{'comment': 'As units: 3 MIH affected molars failures to attend follow up at 6 months which involved 3 participants', 'groupId': 'FG000', 'numUnits': '18', 'numSubjects': '15'}, {'comment': 'As units: 4 MIH affected molars failures to attend follow up at 6 months which involved 3 participants', 'groupId': 'FG001', 'numUnits': '17', 'numSubjects': '16'}, {'comment': 'As units: 4 MIH affected molars failures to attend follow up at 6 months which involved 4 participants', 'groupId': 'FG002', 'numUnits': '17', 'numSubjects': '16'}]}, {'type': '12 Months', 'achievements': [{'comment': 'As units: 8 MIH affected molars failures to attend follow up at 12 months which involved 7 participants', 'groupId': 'FG000', 'numUnits': '13', 'numSubjects': '11'}, {'comment': 'As units: 6 MIH affected molars failures to attend follow up at 12 months which involved 6 participants', 'groupId': 'FG001', 'numUnits': '15', 'numSubjects': '13'}, {'comment': 'As units: 5 MIH affected molars failures to attend follow up at 12 months which involved 5 participants', 'groupId': 'FG002', 'numUnits': '16', 'numSubjects': '15'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '13', 'numSubjects': '11'}, {'groupId': 'FG001', 'numUnits': '15', 'numSubjects': '13'}, {'groupId': 'FG002', 'numUnits': '16', 'numSubjects': '15'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '8', 'numSubjects': '7'}, {'groupId': 'FG001', 'numUnits': '6', 'numSubjects': '6'}, {'groupId': 'FG002', 'numUnits': '5', 'numSubjects': '5'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '5'}]}]}], 'typeUnitsAnalyzed': 'number of MIH affected molars', 'recruitmentDetails': 'Recruitment period : 1st December 2019 to 6th October 2020 Location: Paediatric Dental Clinic, Faculty of Dentistry, University of Malaya, Kuala Lumpur, Malaysia', 'preAssignmentDetails': '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.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '57', 'groupId': 'BG003'}]}, {'units': 'MIH affected molars', 'counts': [{'value': '21', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}, {'value': '63', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'High Viscosity GIC (HVGIC)', 'description': 'High Viscosity GIC\n\nHigh Viscosity Glass Ionomer Cement: The molar will be restored with HVGIC'}, {'id': 'BG001', 'title': 'Silver Diamine Fluoride (SDF) + HVGIC', 'description': 'SDF and High Viscosity GIC\n\nSilver Diamine Fluoride: A single application of SDF 38% (Riva Star) on dry affected molar for 1 minute and immediately restored using HVGIC'}, {'id': 'BG002', 'title': 'Papain Based Gel + SDF + HVGIC', 'description': 'SDF, Papain-Based Gel and High Viscosity GIC\n\nPapain-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'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'categories': [{'measurements': [{'value': '10.1', 'spread': '2.80', 'groupId': 'BG000'}, {'value': '7.9', 'spread': '1.50', 'groupId': 'BG001'}, {'value': '9.2', 'spread': '2.44', 'groupId': 'BG002'}, {'value': '9.2', 'spread': '2.43', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION', 'denomUnitsSelected': 'Participants'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Male', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '28', 'groupId': 'BG003'}]}]}, {'title': 'Female', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '35', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants', 'denomUnitsSelected': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '57', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'denomUnitsSelected': 'Participants'}, {'title': 'MIH affected molars', 'classes': [{'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '57', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'MIH affected molars were used to represent as baseline participants assigned into intervention group. 1 participants may have more than 1 MIH affected molars being assigned into the same or different intervention group.', 'unitOfMeasure': 'Participants', 'denomUnitsSelected': 'Participants'}], 'typeUnitsAnalyzed': 'MIH affected molars', 'populationDescription': 'MIH affected molars represent the number of participants analysed for each treatment interventions.This is because one participant can have more than one MIH affected molars assigned into the same or different treatment groups. The total number of participants involved in this study was 38 with 63 MIH affected molars involved. Total number of participants at baseline (1 participants may have \\>1 MIH molars into same or different group) assigned into all interventions was 57.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-03-15', 'size': 188170, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-03-19T16:57', 'hasProtocol': True}, {'date': '2020-03-15', 'size': 323752, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2021-01-09T02:44', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'Participant were not informed regarding intervention given'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 38}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-12-01', 'type': 'ACTUAL'}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2021-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-06-29', 'studyFirstSubmitDate': '2020-12-27', 'resultsFirstSubmitDate': '2023-03-19', 'studyFirstSubmitQcDate': '2021-01-12', 'lastUpdatePostDateStruct': {'date': '2023-07-20', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-06-29', 'studyFirstPostDateStruct': {'date': '2021-01-15', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-07-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-05-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical Outcome Based on Success After Intervention on MIH Affected Molar at 6 Months', 'timeFrame': '6 month', '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\n\n1. Absence of pain related to the treated tooth/teeth\n2. Absence of tenderness to percussion (TTP)\n3. No evidence of swelling of supporting soft tissue or presence of a sinus tract\n4. Absence of enamel breakdown and caries along margin of restoration\n5. Scale 0 and 1 for Schiff Cold Air Sensitivity Scale"}, {'measure': 'Clinical Outcome Based on Success After Intervention on MIH Affected Molar at 12 Months', 'timeFrame': '12 month', '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\n\n1. Absence of pain related to the treated tooth/teeth\n2. Absence of tenderness to percussion (TTP)\n3. No evidence of swelling of supporting soft tissue or presence of a sinus tract\n4. Absence of enamel breakdown and caries along margin of restoration\n5. Scale 0 and 1 for Schiff Cold Air Sensitivity Scale"}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['molar incisor hypomineralization', 'silver diamine fluoride', 'deproteinizing agent'], 'conditions': ['Molar Incisor Hypomineralization', 'Dental Caries', 'Hypomineralization of Enamel']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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.\n\nClinical 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:\n\nFor 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.\n\nThe 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"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '15 Years', 'minimumAge': '5 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Healthy with ability to comprehend instruction and perform oral hygiene care independently\n2. Hypomineralised First Permanent Molar with:\n\n2.1 Post Eruptive Breakdown (Code 3)\n\n2.2 Atypical restoration (Code 4) which is unsatisfactory or with secondary caries that require replacement\n\n2.3 Atypical caries (Code 5) with enamel breakdown\n\nExclusion Criteria:\n\n1. Patient with silver allergy\n2. First Permanent Molar with:\n\n2.1 Non-MIH defect\n\n2.2 White, creamy demarcated yellow or brown opacities (Code 2)\n\n2.3 Good satisfactory atypical restoration (Code 4)\n\n2.4 Atypical caries (Code 5) with pulpal involvement -Irreversible pulpitis and pulpal necrosis\n\n2.5 Extensive coronal breakdown (Code 7)'}, 'identificationModule': {'nctId': 'NCT04710927', 'briefTitle': 'Silver Diamine Fluoride and Papain-Based Gel for Management of MIH-affected Molar in Paediatric Patients', 'organization': {'class': 'OTHER', 'fullName': 'University of Malaya'}, 'officialTitle': 'The Use of Silver Diamine Fluoride and Papain-Based Gel for Management of MIH-affected Molar in Paediatric Patients: A Randomised Controlled Trial', 'orgStudyIdInfo': {'id': 'DF CD1912/0061/20155(P)'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'High Viscosity GIC (HVGIC)', 'description': 'Group 1', 'interventionNames': ['Device: High Viscosity Glass Ionomer Cement (HVGIC)']}, {'type': 'EXPERIMENTAL', 'label': 'Silver Diamine Fluoride (SDF) + HVGIC', 'description': 'Group 2', 'interventionNames': ['Device: Silver Diamine Fluoride']}, {'type': 'EXPERIMENTAL', 'label': 'Papain based gel + SDF + HVGIC', 'description': 'Group 3', 'interventionNames': ['Device: Papain-Based Gel']}], 'interventions': [{'name': 'Silver Diamine Fluoride', 'type': 'DEVICE', 'otherNames': ['Riva Star'], 'description': 'A single application of SDF 38% (Riva Star) on dry affected molar for 1 minute and immediately restored using HVGIC', 'armGroupLabels': ['Silver Diamine Fluoride (SDF) + HVGIC']}, {'name': 'Papain-Based Gel', 'type': 'DEVICE', 'otherNames': ['Papacare Duo'], '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', 'armGroupLabels': ['Papain based gel + SDF + HVGIC']}, {'name': 'High Viscosity Glass Ionomer Cement (HVGIC)', 'type': 'DEVICE', 'otherNames': ['Riva Self Cure HV'], 'description': 'The molar will be restored with HVGIC', 'armGroupLabels': ['High Viscosity GIC (HVGIC)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '50603', 'city': 'Kuala Lumpur', 'state': 'Kuala Lumpur', 'country': 'Malaysia', 'facility': 'Faculty of Dentistry, University of Malaya', 'geoPoint': {'lat': 3.1412, 'lon': 101.68653}}], 'overallOfficials': [{'name': 'Tengku Nurfarhana Bt Tengku Hamzah', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Malaya'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Malaya', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer in Paediatric Dentistry', 'investigatorFullName': 'Dr Tengku Nurfarhana Nadirah Bt Tengku Hamzah', 'investigatorAffiliation': 'University of Malaya'}}}}