Ignite Creation Date:
2025-12-25 @ 4:59 AM
Ignite Modification Date:
2025-12-26 @ 3:59 AM
Study NCT ID:
NCT04401618
Status:
COMPLETED
Last Update Posted:
2021-05-11
First Post:
2020-05-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Retrospective Evaluation of RMGI/GI Class V Restorations
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2019-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-05-07', 'studyFirstSubmitDate': '2020-05-14', 'studyFirstSubmitQcDate': '2020-05-19', 'lastUpdatePostDateStruct': {'date': '2021-05-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Post-Operative Sensitivity', 'timeFrame': '2 years', 'description': 'Absence of sensitivity to pressure, cold or hot temperature on the teeth restored (checked verbally by inquiring the patient about the presence or absence of pain in the presence of stimuli)'}, {'measure': 'Secondary Caries', 'timeFrame': '2 years', 'description': 'No visual evidence of dark, deep discolouration or cavitation adjacent to the restoration (visually and manually checked with the tip of a dental hand instrument - explorer)'}, {'measure': 'Anatomic Form', 'timeFrame': '2 years', 'description': "Restoration's anatomy is continuous with existing anatomic form of remaining tooth structure (checked visually with a dental intra-oral mirror)"}, {'measure': 'Color match', 'timeFrame': '2 years', 'description': 'No difference between the tooth and restoration colour (checked visually with a dental intra-oral mirror)'}, {'measure': 'Surface Roughness', 'timeFrame': '2 years', 'description': 'Surface texture of the restoration is similar to tooth structure (manually checked with the tip of a dental hand instrument - explorer)'}, {'measure': 'Marginal Discolouration', 'timeFrame': '2 years', 'description': 'No visual evidence of dark discolouration adjacent to the margins of the restoration (checked visually with a dental intra-oral mirror)'}, {'measure': 'Marginal Integrity', 'timeFrame': '2 years', 'description': 'Restoration closely adapted to the tooth. No crevice visible (manually checked with the tip of a dental hand instrument - explorer)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Glass-Ionomer Cement', 'Polyacid-Modified Composite Resin', 'Dental School'], 'conditions': ['Material, Dental']}, 'referencesModule': {'references': [{'pmid': '24671713', 'type': 'BACKGROUND', 'citation': 'Santos MJ, Ari N, Steele S, Costella J, Banting D. Retention of tooth-colored restorations in non-carious cervical lesions--a systematic review. Clin Oral Investig. 2014;18(5):1369-81. doi: 10.1007/s00784-014-1220-7. Epub 2014 Mar 27.'}, {'pmid': '9002808', 'type': 'BACKGROUND', 'citation': 'Neo J, Chew CL, Yap A, Sidhu S. Clinical evaluation of tooth-colored materials in cervical lesions. Am J Dent. 1996 Feb;9(1):15-8.'}, {'pmid': '16924979', 'type': 'BACKGROUND', 'citation': 'Franco EB, Benetti AR, Ishikiriama SK, Santiago SL, Lauris JR, Jorge MF, Navarro MF. 5-year clinical performance of resin composite versus resin modified glass ionomer restorative system in non-carious cervical lesions. Oper Dent. 2006 Jul-Aug;31(4):403-8. doi: 10.2341/05-87.'}, {'pmid': '16005793', 'type': 'BACKGROUND', 'citation': 'van Dijken JW. Retention of a resin-modified glass ionomer adhesive in non-carious cervical lesions. A 6-year follow-up. J Dent. 2005 Aug;33(7):541-7. doi: 10.1016/j.jdent.2004.11.015. Epub 2005 Feb 8.'}, {'pmid': '23088188', 'type': 'BACKGROUND', 'citation': 'Imbery TA, Namboodiri A, Duncan A, Amos R, Best AM, Moon PC. Evaluating dentin surface treatments for resin-modified glass ionomer restorative materials. Oper Dent. 2013 Jul-Aug;38(4):429-38. doi: 10.2341/12-162-L. Epub 2012 Oct 22.'}]}, 'descriptionModule': {'briefSummary': 'Brief Summary: Retrospective study to evaluate the clinical performance of two restorative materials - glass-ionomer (GI) and resin-modified glass-ionomer (RMGI) materials - in Class V carious and non-carious cervical lesions restored by dental students.', 'detailedDescription': 'The aim of this retrospective study was to evaluate the clinical performance of glass-ionomer (GI) and resin-modified glass-ionomer (RMGI) materials in Class V carious and non-carious cervical lesions restored by dental students. Ninety-six (96) restorations performed with either GI (Fuji IX) (n=39) or RMGI (Fuji II) (n=57) were evaluated using the modified USPHS (United States Public Health Systems) criteria by two independent investigators at two follow-up evaluations (two years apart). The Fisher statistical test was used to compare USPHS criteria and examine significant differences by setting p\\<0.05 for statistical significance and the Kaplan-Meier algorithm was used to calculate the survival probability.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adults that have Class V Ionomer restorations (RMGI and GIC) placed by 3rd and 4th dental students at the Schulich Dental Clinic over the last three years.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n• Class V Ionomer restorations (RMGI and GIC) placed by 3rd and 4th dental students over the last three years.\n\nExclusion Criteria:\n\n* Class V Restorations placed outside of the dental school\n* Class V Restorations that used other restorative materials Class V Ionomer restorations (RMGI and GIC0 placed before three years on the time of evaluation.'}, 'identificationModule': {'nctId': 'NCT04401618', 'briefTitle': 'Retrospective Evaluation of RMGI/GI Class V Restorations', 'organization': {'class': 'OTHER', 'fullName': 'Western University, Canada'}, 'officialTitle': 'Retrospective Clinical Evaluation of RMGI/GI Class V Restorations Placed by Dental Students', 'orgStudyIdInfo': {'id': '107864'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Class V RMGI Restorations', 'description': 'Resin-modified glass ionomer (RMGI - Fuji 2 LC) Class V restorations performed by by 3rd and 4th-year dental students in adult patients of Schulich dental clinic over the last three years will be evaluated using mirrors and probes.', 'interventionNames': ['Other: Retrospective evaluation of RMGI and GIC Class V Restorations']}, {'label': 'Class V Glass ionomer - GIC Restorations', 'description': 'Glass ionomer (GI - Fuji 9) Class V restorations performed by by 3rd and 4th-year dental students in adult patients of Schulich dental clinic over the last three years will be evaluated using mirrors and probes.', 'interventionNames': ['Other: Retrospective evaluation of RMGI and GIC Class V Restorations']}], 'interventions': [{'name': 'Retrospective evaluation of RMGI and GIC Class V Restorations', 'type': 'OTHER', 'description': 'Retrospective evaluation of RMGI and GIC Class V Restorations that were placed by dental students over the last three years were evaluated using the modified USPHS criteria using mirrors and probes.', 'armGroupLabels': ['Class V Glass ionomer - GIC Restorations', 'Class V RMGI Restorations']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'N6A5C1', 'city': 'London', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Schulich Medicine and Dentistry - Western University', 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}], 'overallOfficials': [{'name': 'Maria Jacinta Santos, Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Schulich Dentistry-Western University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Western University, Canada', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Maria Jacinta Santos', 'investigatorAffiliation': 'Western University, Canada'}}}}