Ignite Creation Date:
2025-12-25 @ 4:26 AM
Ignite Modification Date:
2025-12-26 @ 3:29 AM
Study NCT ID:
NCT04679220
Status:
COMPLETED
Last Update Posted:
2020-12-22
First Post:
2020-12-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
36-Months Clinical Evaluation of Preheated and Room Temperature Resin Composite
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003763', 'term': 'Dental Leakage'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'One side of the mouth received preheated composite however in the other side the composite was placed in non-heated state following the manufacturer instructions.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 35}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2020-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-12-17', 'studyFirstSubmitDate': '2020-12-14', 'studyFirstSubmitQcDate': '2020-12-17', 'lastUpdatePostDateStruct': {'date': '2020-12-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage % of patients with marginal staining', 'timeFrame': '3 years after restoration procedure', 'description': 'Percentage of marginal staining in patients was clinically assessed using World Dental Federation FDI parameters using a scale from 1 to 5 scores (clinically very good, clinically good, clinically satisfactory, clinically unsatisfactory and clinically poor)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Resin Composite', 'Pain', 'Randomized Clinical Trial', 'Operative Dentistry', 'Preheating'], 'conditions': ['Dental Leakage']}, 'descriptionModule': {'briefSummary': 'Summary The aim of this study was to evaluate the effect of preheating resin composite (RC) on clinical performance of class I restorations in a period of 3-years using a split-mouth double-blinded randomized design.', 'detailedDescription': "The description of the experimental design followed the Consolidated Standards of Reporting Trials (CONSORT) statement. The present study was a double-blinded (patients and examiner) randomized clinical trial anticipating the split mouth design. Thirty-five adult patients seeking dental treatment in Operative Department clinic at Faculty of Dentistry, University of Mansoura were enrolled in the current study with a total of 70 Class I restorations. No advertisement was made for participant recruitment, forming a sample of convenience. Each patient much sign a consent form before participating in the current study. The study was conducted from October 2017 to June 2020 as a part of Doctoral dissertation. Mansoura University institution's ethics committee approved the form and protocol before conducting the study. The sample size was calculated based on the clinical success rate (100% retention rate at 3 years) of posterior class I restorations restored with nanofilled composite observed in a previous study.28 According to several parameters including a significance level of 5%, the power of the test was calculated to be 80%, and equivalent limit of 15%. Upon these data, a sample size of 30 subjects was appropriate. Allowing for a 20% drop-out, sample size was set totalizing 35 subjects."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with primary caries involving occlusal surface only with ICDAS 2 and 3\n* Patients with cavities no more than one-third of the intercuspal distance\n* Patients must have a good oral hygiene;\n* Patients with tooth gives 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* Patients involved in orthodontic treatment or periodontal surgery,\n* Patients with periodontally involved teeth (chronic periodontitis)\n* Patients with abutments should be excluded.\n* Patients with heavy bruxism habits and clenching'}, 'identificationModule': {'nctId': 'NCT04679220', 'briefTitle': '36-Months Clinical Evaluation of Preheated and Room Temperature Resin Composite', 'organization': {'class': 'OTHER', 'fullName': 'Mansoura University'}, 'officialTitle': '36-Months Clinical Evaluation of Preheated Resin Composite', 'orgStudyIdInfo': {'id': '36.MCEPRCRCL'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Non-heated Resin Composite group', 'description': 'Patients received Non-heated nanofilled resin composite on one side of the mouth', 'interventionNames': ['Procedure: Preheating']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Preheated Resin Composite group', 'description': 'Patients received preheated nanofilled resin composite on the other side of the mouth', 'interventionNames': ['Procedure: Preheating']}], 'interventions': [{'name': 'Preheating', 'type': 'PROCEDURE', 'description': "For preheating RC prior to placement, a device called Therma-flo TM RC warming kit (Vista, Wisconsin, USA) was used according to manufacturer's instructions to preheat resin composites", 'armGroupLabels': ['Non-heated Resin Composite group', 'Preheated Resin Composite group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35516', 'city': 'Al Mansurah', 'state': 'Dakahlia Governorate', 'country': 'Egypt', 'facility': 'Faculty of Dentistry', 'geoPoint': {'lat': 31.03637, 'lon': 31.38069}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': 'Data will be available within 3 Months for 3 years', 'ipdSharing': 'YES', 'description': 'Study Protocol, Statistical Analysis Plan can be shared to other researchers', 'accessCriteria': 'for anyone'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mansoura University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}