Ignite Creation Date:
2025-12-24 @ 10:56 PM
Ignite Modification Date:
2026-06-14 @ 3:08 PM
Study NCT ID:
NCT03153969
Status:
COMPLETED
Last Update Posted:
2022-11-16
First Post:
2017-05-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Evaluation of a New Giomer Restorative System in Class V Restorations
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2025-06-18', 'mcpReleaseN': 8, 'releaseDate': '2025-06-04'}, {'resetDate': '2025-07-31', 'mcpReleaseN': 9, 'releaseDate': '2025-07-14'}, {'resetDate': '2025-08-21', 'mcpReleaseN': 10, 'releaseDate': '2025-08-04'}, {'resetDate': '2025-12-16', 'mcpReleaseN': 11, 'releaseDate': '2025-11-21'}], 'estimatedResultsFirstSubmitDate': '2025-06-04'}}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 49}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-08-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2022-11-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-11-15', 'studyFirstSubmitDate': '2017-05-11', 'studyFirstSubmitQcDate': '2017-05-12', 'lastUpdatePostDateStruct': {'date': '2022-11-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hickel Criteria', 'timeFrame': 'Up to 18 months', 'description': "Clinical assessments (Esthetic properties: surface luster, surface staining, marginal staining, color match, anatomical form, Functional properties: marginal adaptation, fracture of material and retention, radiographic examination, patient's view, and Biological Properties: postoperative hypersensitivity, recurrence of caries, tooth integrity and adjacent mucosa) will be performed by two trained examiners other than the operating clinician using modified Hickel criteria at baseline and follow-up visits. Differences between the two groups for Hickel criteria items will be examined with the Wilcoxon signed-rank test."}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Non-carious Cervical Lesions']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to evaluate the clinical effectiveness of a new composite resin (SHOFU Beautifil II LS) vs a control (3M/ESPE Filtek Supreme) for use in restoring non carious cervical lesions Class V lesions.\n\n3M ESPE FiltekTM Supreme is one of the composite resin materials that will be used in this study (Group 1). This is a light-activated, flowable restorative composite.\n\nShofu Beautifil II LS (SI R21204) is a new type of filling material called a Giomer. This is the second composite that will be used in this study (Group 2) Giomer is a collective term for dental materials that will release ions, such as fluoride. Results from previous studies show that the released ions may have beneficial effects on the tooth, including strengthening the tooth.\n\nIn each participant, one tooth with a class V lesion will be randomized to group 1, and a second tooth with a class V lesion will be randomized to group 2. The restorations will be observed over 18 months to determine clinical acceptability.', 'detailedDescription': "This is a single-center, non-blinded, controlled, split mouth, clinical trial 18 months in duration.\n\nThe purpose of this clinical trial is to evaluate the effectiveness of a new Giomer restorative system (Shofu Beautifil LS) for use in restoring non carious Class V lesions by comparing it to 3M ESPE FiltekTM Supreme in the following categories:\n\nClinical Assessments (Documentation at baseline, 6months and 18months):\n\n* Surface Luster\n* Surface Staining\n* Marginal Staining\n* Color Match\n* Anatomical Form\n* Marginal Adaptation\n* Fracture of Material and Retention\n* Radiographic Examination\n* Patient's View\n* Postoperative Hypersensitivity\n* Recurrence of Caries\n* Tooth Integrity\n* Adjacent Mucosa\n\nSensitivity interview- assessed preoperatively (prior to anesthesia, if needed) at baseline and after restoration placement\n\nDentin Sclerosis Rating- assessed at baseline"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* 18 years or older, in general health\n* Must have a minimum of 2 cervical lesions in need of restoration\n* Cervical lesions must provide for a minimum of 1mm thickness of restorative material while maintaining natural tooth contour\n* At least 50% of lesion must be in dentin\n* Coronal margin of lesion must be in enamel\n\nExclusion Criteria:\n\n* Rampant uncontrolled caries\n* Systemic or local disorders that contra-indicate the dental procedures included in this study\n* Evidence of xerostomia\n* Evidence of severe bruxing or clenching or in need of TMJ related therapy\n* Women who are pregnant or breast feeding (self-reported).\n* Known allergy to resin composites or local anesthetics\n* Abnormal oral soft tissue findings (e.g., open sores, lesions)\n* Condition affecting salivary flow (e.g., salivary gland disorder, Sjögren's Syndrome)\n* Teeth with periapical pathology or exhibiting symptoms of pulpal pathology\n* Teeth that are non-vital or have had root canal therapy\n* Teeth that have been pulp capped\n* Teeth with near exposures on pre-operative radiographs\n* Hypersensitive teeth\n* Teeth with a periodontal pocket of more than 4mm with bleeding on probing\n* Teeth that are used as abutments for removable partial dentures"}, 'identificationModule': {'nctId': 'NCT03153969', 'briefTitle': 'Clinical Evaluation of a New Giomer Restorative System in Class V Restorations', 'organization': {'class': 'OTHER', 'fullName': 'Tufts University'}, 'officialTitle': 'A Clinical Trial to Evaluate a New Giomer Restorative System in Class V Restorations', 'orgStudyIdInfo': {'id': '12486'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SHOFU Beautifil II LS', 'description': 'Composite: SHOFU Beautifil II LS, Bonding Agent: SHOFU BeautiBond', 'interventionNames': ['Device: SHOFU Beautifil II LS']}, {'type': 'ACTIVE_COMPARATOR', 'label': '3M/ESPE Filtek Supreme', 'description': 'Composite: 3M/ESPE Filtek Supreme, Bonding Agent: 3M/ESPE Scotchbond Universal', 'interventionNames': ['Device: 3M/ESPE Filtek Supreme']}], 'interventions': [{'name': 'SHOFU Beautifil II LS', 'type': 'DEVICE', 'description': "Placed under manufacturer's instructions", 'armGroupLabels': ['SHOFU Beautifil II LS']}, {'name': '3M/ESPE Filtek Supreme', 'type': 'DEVICE', 'description': "Placed under manufacturer's instructions", 'armGroupLabels': ['3M/ESPE Filtek Supreme']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02111', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Tufts University School of Dental Medicine', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Gerard Kugel, DMD, MS, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tufts University School of Dental Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tufts University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Shofu Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Dr. Gerard Kugel', 'investigatorAffiliation': 'Tufts University'}}}}