Ignite Creation Date:
2025-12-26 @ 5:20 PM
Ignite Modification Date:
2025-12-31 @ 6:01 PM
Study NCT ID:
NCT03193606
Status:
COMPLETED
Last Update Posted:
2019-05-03
First Post:
2017-06-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Radiographic Assessment of Glass Ionomer Restorations With and Without Prior Application of Nano Silver Fluoride in Occlusal Carious Molars Treated With Partial Caries Removal Technique
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2020-06-25', 'releaseDate': '2020-06-06'}, {'resetDate': '2020-08-03', 'releaseDate': '2020-07-18'}], 'estimatedResultsFirstSubmitDate': '2020-06-06'}}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'split mouth randomized clinical trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-07-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'completionDateStruct': {'date': '2019-03-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-05-01', 'studyFirstSubmitDate': '2017-06-19', 'studyFirstSubmitQcDate': '2017-06-19', 'lastUpdatePostDateStruct': {'date': '2019-05-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-06-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-02-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Caries remineralization. (Mineral density)', 'timeFrame': 'six months', 'description': 'using Density measurement tool in the Digora software'}], 'secondaryOutcomes': [{'measure': 'dentin bridge formation.', 'timeFrame': 'six months', 'description': 'Linear measurement tool in the Digora software in Mm'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Partial Dentin Caries Removal']}, 'referencesModule': {'references': [{'pmid': '24930870', 'type': 'BACKGROUND', 'citation': 'Santos VE Jr, Vasconcelos Filho A, Targino AG, Flores MA, Galembeck A, Caldas AF Jr, Rosenblatt A. A new "silver-bullet" to treat caries in children--nano silver fluoride: a randomised clinical trial. J Dent. 2014 Aug;42(8):945-51. doi: 10.1016/j.jdent.2014.05.017. Epub 2014 Jun 12.'}]}, 'descriptionModule': {'briefSummary': 'eligible teeth will be randomly divided into two groups to be treated with incomplete caries excavation (A), where (A1) represents teeth to be treated with application of Nano silver fluoride solution on remaining carious dentin prior to final permanent glass ionomer restoration application, (A2) represents comparator group to be restored without Nano silver fluoride application prior to restoration. Every participant will receive both the intervention and control treatment. Image of radiographic density of remaining carious dentin will be evaluated using PSP plate at baseline immediately after restoration and after 6 months after restorative procedures.\n\nThe null hypothesis tested is that application of Nano silver fluoride solution prior to glass ionomer restoration will not increase radiopacity of the underlying dentin treated by incomplete carious removal technique compared to that of direct glass ionomer restoration without prior application of Nano silver fluoride.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '35 Years', 'minimumAge': '16 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients presenting with at least 2 teeth with active carious lesions limited to the occlusal surface of molars at risk of pulp exposure during direct complete excavation (primary caries lesion involving more than half of the entire dentin thickness determined radiographically).\n* Signs and symptoms indicative of pulp vitality, i.e. a positive response to thermal stimulation during a cold test\n* Absence of apical pathosis, clinical diagnosis of pulp exposure, fistula, swelling of periodontal tissues.\n\nExclusion Criteria:\n\n* Teeth with spontaneous pain or sensitivity to percussion.\n* Teeth with periodontal lesions, internal or external root resorption, mobility of tooth, sinus opening, or abscessed tooth.\n* Radiographic examination revealed, interrupted or broken lamina dura, widened periodontal ligament space, periapical radiolucency.\n* patients with systemic medical conditions\n* pregnant females'}, 'identificationModule': {'nctId': 'NCT03193606', 'briefTitle': 'Radiographic Assessment of Glass Ionomer Restorations With and Without Prior Application of Nano Silver Fluoride in Occlusal Carious Molars Treated With Partial Caries Removal Technique', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Radiographic Assessment of Glass Ionomer Restorations With and Without Prior Application of Nano Silver Fluoride in Occlusal Carious Molars Treated With Partial Caries Removal Technique (Randomized Clinical Trial)', 'orgStudyIdInfo': {'id': 'CEBC-CU-2017-06-15'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'nano silver fluoride solution', 'description': 'carious dentin to be treated with partial caries excavation with application of nano silver fluoride solution prior to glass ionomer restoration.', 'interventionNames': ['Other: nano silver fluoride solution']}, {'type': 'NO_INTERVENTION', 'label': 'no nano silver fluoride', 'description': 'carious dentin to be treated with partial caries excavation without application of nano silver fluoride solution restored directly with glass ionomer.'}], 'interventions': [{'name': 'nano silver fluoride solution', 'type': 'OTHER', 'description': 'prepared Nano-silver fluoride could have the capability to arrest caries. As its Nano silver particles have an antimicrobial activity against Mutans Streptococci and Lactobacilli; the main pathogens involved in the development of carious lesions. In addition, its fluoride component is well known to enhance remineralization and inhibit bacterial activity. So, Nano silver fluoride could be a promising solution to combat residual bacteria in tooth cavity with effective remineralization potential on remaining carious dentin', 'armGroupLabels': ['nano silver fluoride solution']}]}, 'contactsLocationsModule': {'locations': [{'zip': '002', 'city': 'Giza', 'country': 'Egypt', 'facility': 'Rahma Ahmed', 'geoPoint': {'lat': 30.00944, 'lon': 31.20861}}], 'overallOfficials': [{'name': 'Heba Ah El deeb', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Associate professor, Conservative dentistry department Cairo University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'teaching assisstant', 'investigatorFullName': 'Rahma Ahmed Ibrahem Hafiz', 'investigatorAffiliation': 'Beni-Suef University'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2020-06-06', 'type': 'RELEASE'}, {'date': '2020-06-25', 'type': 'RESET'}, {'date': '2020-07-18', 'type': 'RELEASE'}, {'date': '2020-08-03', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Rahma Ahmed Ibrahem Hafiz, teaching assisstant, Beni-Suef University'}}}}