Ignite Creation Date:
2025-12-25 @ 4:59 AM
Ignite Modification Date:
2026-01-07 @ 11:07 AM
Study NCT ID:
NCT06164418
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-06-03
First Post:
2023-12-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparative Evaluation of Class V Restorations
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'Double (Participant and Investigator)'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': "Each patient will receive one restoration in a posterior tooth on any side randomly selected from the 4 tested restorative systems groups, all materials will be used according to manufacturers' instructions"}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-12-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2025-12-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-02', 'studyFirstSubmitDate': '2023-12-02', 'studyFirstSubmitQcDate': '2023-12-02', 'lastUpdatePostDateStruct': {'date': '2025-06-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-12-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of aesthetic, functional and biological properties for each group', 'timeFrame': '2 years after restoration', 'description': 'Percentage of aesthetic, functional and biological properties that will be clinically assessed using World Dental Federation parameters for each restorative system group'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Secondary Caries', 'Dental Restoration Failure of Marginal Integrity']}, 'descriptionModule': {'briefSummary': 'To evaluate and compare the 2-year clinical performance of Class V restorations using various restorative systems with ion-releasing and non-ion-releasing composites, utilizing fluoride-free and fluoride-releasing universal adhesives for bonding', 'detailedDescription': "The experimental design description adhered to the guidelines provided by the Consolidated Standards of Reporting Trials (CONSORT) statement. The present study is planned as a double-blinded randomized clinical trial, ensuring that both the patients and the examiner are unaware of the treatment allocation. The trial will follow a parallel design. A total of one hundred adult patients, who are seeking dental treatment, will be enrolled in the study. The participants will be recruited from the Operative Department clinic at the Faculty of Dentistry, University of Mansoura. The study will focus on one hundred Class V restorations.\n\nNo active advertisement will be used for participant recruitment, and instead, a convenience sample will be formed. Prior to participating in the study, each patient will be required to provide informed consent by signing a consent form. The study is scheduled to be conducted from November 2023 to November 2025. The form and protocol of the study will be approved by Mansoura University's ethics committee before initiation.\n\nTo determine the appropriate sample size, previous studies examining the clinical success rate of posterior class V restorations restored with ion-releasing materials were considered. These studies reported a 100% success rate at a two-year follow-up. Based on various parameters, including a significance level of 5%, a test power of 80%, and an equivalence limit of 15%, the sample size was calculated. Considering a potential dropout rate of 20%, a sample size of 100 subjects was determined to be suitable."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '35 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with one primary cervical caries on the buccal surface of any of their upper or lower posterior teeth. The cervical lesions must have an enamel margin occlusally and a cervical dentin margin\n* Patients must have a good oral hygiene;\n* Patients with tooth gives a positive response to testing with an electric pulp tester\n* Patients with normal and full occlusion,\n* Patients with opposing teeth should be natural with no restorations.\n\nExclusion Criteria:\n\n\\- High caries risk patients with extremely poor oral hygiene,\n\n* Patients involved in orthodontic treatment or periodontal surgery,\n* Patients with periodontally involved teeth (chronic periodontitis)\n* Patients with heavy bruxism habits and clenching'}, 'identificationModule': {'nctId': 'NCT06164418', 'briefTitle': 'Comparative Evaluation of Class V Restorations', 'organization': {'class': 'OTHER', 'fullName': 'Mansoura University'}, 'officialTitle': 'Comparative Evaluation of Class V Restorations: 2-Year Randomized Double-Blind Trial Comparing Ion-Releasing Materials and Resin Composite', 'orgStudyIdInfo': {'id': 'A01011023 CD'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'a nanohybrid resin composite material with a universal adhesive', 'description': 'Each patient will randomly receive one cervical restoration with one of the tested restorative systems', 'interventionNames': ['Procedure: Dental restoration']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'a nanohybrid resin composite material with a fluoride-releasing universal adhesive', 'description': 'Each patient will randomly receive one cervical restoration with one of the tested restorative systems', 'interventionNames': ['Procedure: Dental restoration']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'ion-releasing restorative material with a universal adhesive', 'description': 'Each patient will randomly receive one cervical restoration with one of the tested restorative systems', 'interventionNames': ['Procedure: Dental restoration']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'ion-releasing restorative material with a fluoride-releasing universal adhesive', 'description': 'Each patient will randomly receive one cervical restoration with one of the tested restorative systems', 'interventionNames': ['Procedure: Dental restoration']}], 'interventions': [{'name': 'Dental restoration', 'type': 'PROCEDURE', 'description': 'Each patient will receive a cervical restoration using the corresponding group adhesive and restorative material', 'armGroupLabels': ['a nanohybrid resin composite material with a fluoride-releasing universal adhesive', 'a nanohybrid resin composite material with a universal adhesive', 'ion-releasing restorative material with a fluoride-releasing universal adhesive', 'ion-releasing restorative material with a universal adhesive']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35516', 'city': 'Al Mansurah', 'state': 'Dakahliya', 'country': 'Egypt', 'facility': 'Hoda Saleh Ismail', 'geoPoint': {'lat': 31.03637, 'lon': 31.38069}}], 'overallOfficials': [{'name': 'Hoda S Ismail, Lecturer', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Faculty of Dentistry, Mansoura University, Egypt'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'timeFrame': 'Data will be available within 6 Months for 2 years', 'ipdSharing': 'YES', 'accessCriteria': 'for anyone'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mansoura University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer', 'investigatorFullName': 'Hoda saleh', 'investigatorAffiliation': 'Mansoura University'}}}}