Ignite Creation Date:
2025-12-25 @ 2:37 AM
Ignite Modification Date:
2026-02-22 @ 9:05 AM
Study NCT ID:
NCT02604134
Status:
COMPLETED
Last Update Posted:
2019-07-11
First Post:
2015-10-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Medical Management of Caries in the Primary Dentition Using Silver Nitrate
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003731', 'term': 'Dental Caries'}], 'ancestors': [{'id': 'D017001', 'term': 'Tooth Demineralization'}, {'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005459', 'term': 'Fluorides'}, {'id': 'D012835', 'term': 'Silver Nitrate'}], 'ancestors': [{'id': 'D000838', 'term': 'Anions'}, {'id': 'D007477', 'term': 'Ions'}, {'id': 'D004573', 'term': 'Electrolytes'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D006858', 'term': 'Hydrofluoric Acid'}, {'id': 'D017611', 'term': 'Fluorine Compounds'}, {'id': 'D009566', 'term': 'Nitrates'}, {'id': 'D017942', 'term': 'Nitric Acid'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D018030', 'term': 'Silver Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'the radiographic progression of caries is assessed by a masked investigator'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 122}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2018-08-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-07-09', 'studyFirstSubmitDate': '2015-10-28', 'studyFirstSubmitQcDate': '2015-11-10', 'lastUpdatePostDateStruct': {'date': '2019-07-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-11-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-08-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Pain (toothache) and/or infection in primary teeth', 'timeFrame': 'through study completion, for 2 years', 'description': "Assessments for pain from toothache will be made at each visit throughout the patient's participation in the trial using the Dental Discomfort Questionnaire completed by the parents."}, {'measure': 'Patient quality of life', 'timeFrame': 'through study completion, for 2 years', 'description': 'Quality of life will be assessed through direct reporting by parents and children about pain and related activities'}, {'measure': 'Cost-effectiveness', 'timeFrame': 'through study completion, for 2 years', 'description': 'Cost-effectiveness for both groups will be calculated and compared'}, {'measure': 'Acceptability of treatment strategies by parents and children', 'timeFrame': 'through study completion, for 2 years', 'description': 'Acceptability is checked throughout the whole period of the study every time the patient comes in for a recall'}], 'primaryOutcomes': [{'measure': 'Change in baseline Caries Experience and activity (Incidence of caries in primary teeth)', 'timeFrame': 'through study completion, for 2 years', 'description': 'Detailed measurements of caries experience will be recorded at baseline and annual caries examination using EC4'}], 'secondaryOutcomes': [{'measure': 'Caries activity in primary teeth', 'timeFrame': 'through study completion, for 2 years', 'description': 'Detailed measurements of caries activity will be recorded at baseline and annual caries examination using Nyvad scores.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['silver nitrate', 'children', 'dental caries', 'medical management', 'quality of life'], 'conditions': ['Dental Caries']}, 'referencesModule': {'references': [{'pmid': '23270129', 'type': 'BACKGROUND', 'citation': 'Duffin S. Back to the future: the medical management of caries introduction. J Calif Dent Assoc. 2012 Nov;40(11):852-8.'}, {'pmid': '10355008', 'type': 'BACKGROUND', 'citation': 'Klein U, Kanellis MJ, Drake D. Effects of four anticaries agents on lesion depth progression in an in vitro caries model. Pediatr Dent. 1999 May-Jun;21(3):176-80.'}, {'pmid': '22484380', 'type': 'BACKGROUND', 'citation': 'Peng JJ, Botelho MG, Matinlinna JP. Silver compounds used in dentistry for caries management: a review. J Dent. 2012 Jul;40(7):531-41. doi: 10.1016/j.jdent.2012.03.009. Epub 2012 Apr 3.'}, {'pmid': '26331379', 'type': 'BACKGROUND', 'citation': 'Schwendicke F, Stolpe M, Innes N. Conventional treatment, Hall Technique or immediate pulpotomy for carious primary molars: a cost-effectiveness analysis. Int Endod J. 2016 Sep;49(9):817-826. doi: 10.1111/iej.12537. Epub 2015 Sep 19.'}, {'pmid': '25987388', 'type': 'BACKGROUND', 'citation': 'Innes NP, Stewart M. The Hall Technique, a Simplified Method for Placing Stainless Steel Crowns on Primary Molars, may be as Successful as Traditionally Placed Crowns. J Evid Based Dent Pract. 2015 Jun;15(2):70-2. doi: 10.1016/j.jebdp.2015.03.008. Epub 2015 Mar 28. No abstract available.'}, {'pmid': '25415040', 'type': 'BACKGROUND', 'citation': 'Keightley A, Clarkson J, Maguire A, Speed C, Innes N. Participant recruitment to FiCTION, a primary dental care trial - survey of facilitators and barriers. Br Dent J. 2014 Nov;217(10):E22. doi: 10.1038/sj.bdj.2014.1009.'}, {'pmid': '25343394', 'type': 'BACKGROUND', 'citation': 'Santamaria R, Innes N. Trial shows partial caries removal is an effective technique in primary molars. Evid Based Dent. 2014 Sep;15(3):81-2. doi: 10.1038/sj.ebd.6401044.'}, {'pmid': '25216660', 'type': 'BACKGROUND', 'citation': 'Santamaria RM, Innes NP, Machiulskiene V, Evans DJ, Splieth CH. Caries management strategies for primary molars: 1-yr randomized control trial results. J Dent Res. 2014 Nov;93(11):1062-9. doi: 10.1177/0022034514550717. Epub 2014 Sep 12.'}, {'pmid': '26492796', 'type': 'RESULT', 'citation': 'Lamont T, Schwendicke F, Innes N. Why we need a core outcome set for trials of interventions for prevention and management of caries. Evid Based Dent. 2015 Sep;16(3):66-8. doi: 10.1038/sj.ebd.6401109. No abstract available.'}, {'pmid': '26346538', 'type': 'RESULT', 'citation': 'Schwendicke F, Lamont T, Innes N. Outcomes in Trials for Management of Caries Lesions (OuTMaC): protocol. Trials. 2015 Sep 7;16:397. doi: 10.1186/s13063-015-0927-3.'}]}, 'descriptionModule': {'briefSummary': 'This pilot trial compares conventional restorations with a new strategy based on the medical management of caries using silver nitrate and fluoride varnish with no restorations.', 'detailedDescription': 'This is a two-arm, parallel group, patient-randomized controlled pilot trial. Children with at least one primary tooth where caries extends into dentine. Children will be randomized and treated according to one of two treatment approaches;(1) conventional caries management with best practice prevention, or (2) medical management of caries using silver nitrate with best practice prevention.\n\nBaseline measures and outcome data (at treatment/review during two year follow-up) are assessed through direct reporting, clinical examination including blinded radiographic assessment, and child/parent questionnaires.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '11 Years', 'minimumAge': '2 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Presense of one or more cavitated carious lesions in the primary dentition, extending into dentin but not encroaching on the pulp.\n* Absense of any spontaneous or elicited pain due to caries, or signs of pulpal infection in response to any of the carious lesions in the primary dentition to be included in the study\n\nExclusion Criteria:\n\n* Hereditary developmental defects of the teeth such as Amelogenesis Imperfecta and Dentinogenesis Imperfecta\n* Medical conditions that prevent treatment of the child in the outpatient clinic. These conditions include severe bleeding disorders, cardiac problems and mental disabilities that prevent child from communication with the research team.\n* Known allergy/sensitivity to any of the dental materials.'}, 'identificationModule': {'nctId': 'NCT02604134', 'briefTitle': 'Medical Management of Caries in the Primary Dentition Using Silver Nitrate', 'organization': {'class': 'OTHER', 'fullName': 'University of Iowa'}, 'officialTitle': 'Medical Management of Caries in the Primary Dentition Using Silver Nitrate: A Pilot Study', 'orgStudyIdInfo': {'id': '201406792'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'conventional treatment group', 'description': 'The child will receive a prophylaxis and fluoride varnish. Parents will fill out a parent and a child questionnaire.', 'interventionNames': ['Procedure: Prophylaxis', 'Drug: Fluoride varnish']}, {'type': 'OTHER', 'label': 'Silver Nitrate group', 'description': 'The child will receive a prophylaxis, then silver nitrate and then fluoride varnish. Parents will fill out a parent and a child questionnaire.', 'interventionNames': ['Procedure: Prophylaxis', 'Drug: Fluoride varnish', 'Drug: Silver Nitrate']}], 'interventions': [{'name': 'Prophylaxis', 'type': 'PROCEDURE', 'otherNames': ['Prophy'], 'description': 'A dental prophylaxis is a cleaning procedure performed to thoroughly clean the teeth. Prophylaxis is an important dental treatment for halting the progression of periodontal disease and gingivitis.', 'armGroupLabels': ['Silver Nitrate group', 'conventional treatment group']}, {'name': 'Fluoride varnish', 'type': 'DRUG', 'otherNames': ['Fluoride'], 'description': "Fluoride varnish is a highly concentrated form of fluoride which is applied to the tooth's surface, by a dentist, dental hygienist or other health care professional, as a type of topical fluoride therapy.", 'armGroupLabels': ['Silver Nitrate group', 'conventional treatment group']}, {'name': 'Silver Nitrate', 'type': 'DRUG', 'description': 'a small amount will be applied to the tooth via a cotton applicator. Silver nitrate is a colorless, odorless, transparent solution used as an escharotic, dehydrating and sclerosing agent.', 'armGroupLabels': ['Silver Nitrate group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '52242', 'city': 'Iowa City', 'state': 'Iowa', 'country': 'United States', 'facility': 'UIowa', 'geoPoint': {'lat': 41.66113, 'lon': -91.53017}}], 'overallOfficials': [{'name': 'Arwa I Owais, BDS, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Associate Profesor in Pediatric Dentistry'}, {'name': 'MIchael Kanellis, DDS, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Professor in Pediatric Dentistry & Dean for Patient Cares'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Arwa Owais', 'class': 'OTHER'}, 'collaborators': [{'name': 'Delta Dental of Iowa', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Arwa Owais', 'investigatorAffiliation': 'University of Iowa'}}}}