Ignite Creation Date:
2025-12-25 @ 12:05 AM
Ignite Modification Date:
2026-02-24 @ 8:25 AM
Study NCT ID:
NCT03722758
Status:
UNKNOWN
Last Update Posted:
2019-07-15
First Post:
2018-10-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
36-Month Clinical Performance of Different Restorative Materials in the Treatment of Root Caries Lesions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017213', 'term': 'Root Caries'}], 'ancestors': [{'id': 'D003731', 'term': 'Dental Caries'}, {'id': 'D017001', 'term': 'Tooth Demineralization'}, {'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 33}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2016-07-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2019-11-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-07-11', 'studyFirstSubmitDate': '2018-10-24', 'studyFirstSubmitQcDate': '2018-10-25', 'lastUpdatePostDateStruct': {'date': '2019-07-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-10-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-07-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Marginal adaptation 0 for at least 90% restorations (marginal adaption score)', 'timeFrame': '24 months', 'description': 'The primary factor for determining the clinical performance of a restorative material is the marginal adaption score. It represents the survival rates of the restorations after a period of time. According to ADA guidelines, a restorative material should show at least 90% survival rate after 18. The retention scored as 0 (restoration appears to adapt closely to the surface of the tooth with no crevice formation), 1 (an explorer caught lightly when run in both directions, and there was visible evidence of early crevice formation), 2 (an explorer got caught in both directions and penetrated a marginal crevice), 3 (the crevice had sufficient depth to expose the dentin, required replacement) or 4 (The restoration was fractured or lost).\n\nClinical evaluation is performed to examine if the restorations are in place or fallen.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['micro hybrid resin composite', 'resin-modified glass ionomer', 'split-mouth randomized clinical trial'], 'conditions': ['Root Caries']}, 'descriptionModule': {'briefSummary': 'This is a split-mouth, randomized clinical study that evaluating the 36-month performance of different restorative materials in the treatment of root caries lesions. A total of 110 restorations were randomly placed, half using resin composite (Spectrum TPH3) and the other half using the resin-modified glass ionomer cement (Riva Light Cure). Restorations were evaluated at the baseline, 6, 12, 18,24 and 36 months according to the USPHS criteria.', 'detailedDescription': "The aim of the study was to comparatively assess the 36-month clinical performance of a micro hybrid resin composite and resin-modified glass ionomer cement in root caries lesions.\n\nThirty-three patients with at least two root caries lesions participated in this study. A total of 110 restorations were randomly placed, half using resin composite (Spectrum TPH3) and the other half using the resin-modified glass ionomer cement (Riva Light Cure). Restorations were evaluated at the baseline, 6, 12, 18, 24 and 36 months. The data were analyzed with Pearson's Chi-square, Cochran's Q, Friedman tests and Logistic Regression Analysis (p=0.05)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Root caries lesions (at least 1mm depth)\n\nExclusion Criteria:\n\n* Complex medical history\n* Poor dental hygiene/infrequent practise of oral hygiene habits\n* Severe or chronic periodontitis\n* Extreme carious activity\n* Heavy bruxism\n* Very deep (closer than 0.5 mm to the pulp) or superficial lesions (shallower than 1mm)\n* Previously restored and abutment teeth for bridge or removable dental prostheses'}, 'identificationModule': {'nctId': 'NCT03722758', 'briefTitle': '36-Month Clinical Performance of Different Restorative Materials in the Treatment of Root Caries Lesions', 'organization': {'class': 'OTHER', 'fullName': 'Hacettepe University'}, 'officialTitle': 'Clinical Performance of a Micro-hybride Resin Based Composite in the Treatment of Cervical Caries Lesions: 36-month, Split-mouth, Randomized Clinical Trial', 'orgStudyIdInfo': {'id': '2016/03-23 (KA-16003)'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Spectrum TPH3, tooth restoration', 'description': 'Restoration with micro hybrid resin composite', 'interventionNames': ['Device: Spectrum TPH3', 'Device: Riva LC']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Riva LC, restorative material', 'description': 'Restoration with resin-modified glass ionomer cement', 'interventionNames': ['Device: Spectrum TPH3', 'Device: Riva LC']}], 'interventions': [{'name': 'Spectrum TPH3', 'type': 'DEVICE', 'otherNames': ['resin composite'], 'description': 'tooth restoration with two different restorative materials', 'armGroupLabels': ['Riva LC, restorative material', 'Spectrum TPH3, tooth restoration']}, {'name': 'Riva LC', 'type': 'DEVICE', 'otherNames': ['RMGİC'], 'description': 'tooth restoration with two different restorative materials', 'armGroupLabels': ['Riva LC, restorative material', 'Spectrum TPH3, tooth restoration']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Uzay Koc-Vural', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hacettepe University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hacettepe University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Uzay Koc', 'investigatorAffiliation': 'Hacettepe University'}}}}