Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-30 @ 2:49 AM
Study NCT ID:
NCT07343050
Status:
RECRUITING
Last Update Posted:
2026-01-15
First Post:
2026-01-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Effect of Flowable Composites on Postoperative Sensitivity in Class I Restorations.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}, 'targetDuration': '24 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-05-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2027-08-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-06', 'studyFirstSubmitDate': '2026-01-06', 'studyFirstSubmitQcDate': '2026-01-06', 'lastUpdatePostDateStruct': {'date': '2026-01-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-01-16', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'FDI criteria', 'timeFrame': '2 years', 'description': 'good, very good, poor'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dentin Caries']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to evaluate the effect of flowable conventional and bulk-fill composites on postoperative sensitivity in class I cavities over long-term follow-up. The hypothesis to be tested in this study is that the type of composite material will not affect clinical success.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "The entire study will be conducted at the Restorative Dentistry Department clinic of the Faculty of Dentistry at Recep Tayyip Erdoğan University. Participants who have received routine dental treatment at the university's dental clinic and whose records are kept will be included in the research.", 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* good general health\n* no heart disease\n* no diabetes\n* no systemic diseases such as hypertension\n\nExclusion Criteria:\n\n* Patients with advanced periodontitis and associated postoperative sensitivity,\n* Pregnant and breastfeeding women,\n* Patients undergoing orthodontic treatment,\n* Patients using appliances,\n* Patients with direct pulp capping'}, 'identificationModule': {'nctId': 'NCT07343050', 'briefTitle': 'Evaluation of the Effect of Flowable Composites on Postoperative Sensitivity in Class I Restorations.', 'organization': {'class': 'OTHER', 'fullName': 'Recep Tayyip Erdogan University'}, 'officialTitle': 'Evaluation of Dental Restorations', 'orgStudyIdInfo': {'id': 'RTEUDHFMKARADAS005'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Dental restorations', 'type': 'OTHER', 'description': 'Composite restorations'}]}, 'contactsLocationsModule': {'locations': [{'zip': '53100', 'city': 'Merkez', 'state': 'Rize Province', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Muhammet Karadaş', 'role': 'CONTACT', 'email': 'muhammetkaradas@gmail.com', 'phone': '05383120177'}], 'facility': 'Muhammet Karadaş'}], 'centralContacts': [{'name': 'Muhammet Karadaş', 'role': 'CONTACT', 'email': 'muhammetkaradas@gmail.com', 'phone': '05383120177'}, {'name': 'Elanur Yıldızoğlu', 'role': 'CONTACT', 'email': 'elanur.yildizoglu@erdogan.edu.tr', 'phone': '05535658285'}], 'overallOfficials': [{'name': 'Elanur Yıldızoğlu, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Recep Tayyip Erdogan University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Recep Tayyip Erdogan University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor', 'investigatorFullName': 'Muhammet Karadaş', 'investigatorAffiliation': 'Recep Tayyip Erdogan University'}}}}