Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2025-12-26 @ 12:45 AM
Study NCT ID:
NCT05882760
Status:
COMPLETED
Last Update Posted:
2025-03-06
First Post:
2023-05-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Postoperative Sensitivity Following Placement with Different Restorative Materials in Vital Posterior Teeth
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003807', 'term': 'Dentin Sensitivity'}], 'ancestors': [{'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 160}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-03', 'studyFirstSubmitDate': '2023-05-20', 'studyFirstSubmitQcDate': '2023-05-30', 'lastUpdatePostDateStruct': {'date': '2025-03-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Post Operative Sensitivity', 'timeFrame': '3 Months', 'description': 'Sensitivity will be recorded as present when a patient experienced more pain when the cold stimulus is applied on the restored tooth than on the control tooth is assessed using the modified visual analogue scale to any stimulus (occlusal function, cold/hot water, or sweets) every day by the patient until 7 days, then by the clinician on 7 days, 3 months.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Sensitivity, Tooth']}, 'descriptionModule': {'briefSummary': 'There is a lack of long-term clinical studies comparing different restorative materials; most of the available studies have only looked at class I cavities or examined post-operative sensitivity in non-caries cervical lesions. The purpose of this study is to measure postoperative sensitivity in clinical settings at 3-month intervals for class 1 and 2 direct posterior restoration'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nEither gender Minimum age 18 years, maximum age 40 years. Class I \\& II Cavity on maxillary and mandibular 1st and 2nd molars. Vital maxillary and mandibular molar teeth that had occlusal contact with antagonist teeth.\n\nExclusion Criteria:\n\nIrreversible Pulpitis diagnosed clinically and radiographically. Class I \\& Class II cavity of premolars and third molars Patients taking analgesic prior to treatment. History of allergic reaction to any dental material used in the study. History of parafunctional habits (bruxism and/or clenching) Malocclusion'}, 'identificationModule': {'nctId': 'NCT05882760', 'acronym': 'GCP', 'briefTitle': 'Postoperative Sensitivity Following Placement with Different Restorative Materials in Vital Posterior Teeth', 'organization': {'class': 'OTHER', 'fullName': 'Liaquat University of Medical & Health Sciences'}, 'officialTitle': 'Comparison of Postoperative Sensitivity Following Placement with Different Restorative Materials in Vital Posterior Teeth', 'orgStudyIdInfo': {'id': 'LUMHS/REC/-29'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tetric N Bond Universal®', 'description': 'Cavities in this group will be restored with Conventional Hybrid Composite Restoration bonded with Etch \\& Rinse Technique using Tetric N Bond Universal®.', 'interventionNames': ['Drug: Tetric N Bond Universal®']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Self Etch Tetric N Bond Universal®', 'description': 'Cavities in this group will be restored with Conventional Hybrid Composite Restoration bonded with Self Etch Technique using Tetric N Bond Universal®.', 'interventionNames': ['Drug: Self Etch Tetric N Bond Universal®']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'GC Fuji IX, GC, Japan®', 'description': 'Cavities in this group will be restored with GC Fuji IX, GC, Japan®', 'interventionNames': ['Drug: GC Fuji IX, GC, Japan®']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Activa TM Bioactive Restorative ®', 'description': 'Cavities in this group will be restored with Activa TM Bioactive Restorative ®', 'interventionNames': ['Drug: Activa TM Bioactive Restorative ®']}], 'interventions': [{'name': 'Tetric N Bond Universal®', 'type': 'DRUG', 'description': 'Cavities will be restored with Conventional Hybrid Composite Restoration bonded with Etch \\& Rinse Tetric - N - Bond (Ivoclar)', 'armGroupLabels': ['Tetric N Bond Universal®']}, {'name': 'Self Etch Tetric N Bond Universal®', 'type': 'DRUG', 'description': 'Cavities will be restored with Conventional Hybrid Composite Restoration bonded with Self Etch Tetric N Bond Universal®', 'armGroupLabels': ['Self Etch Tetric N Bond Universal®']}, {'name': 'GC Fuji IX, GC, Japan®', 'type': 'DRUG', 'description': 'Cavities will be restored with GC Fuji IX, GC, Japan®', 'armGroupLabels': ['GC Fuji IX, GC, Japan®']}, {'name': 'Activa TM Bioactive Restorative ®', 'type': 'DRUG', 'description': 'Cavities will be restored with Activa TM Bioactive Restorative ®', 'armGroupLabels': ['Activa TM Bioactive Restorative ®']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hyderābād', 'state': 'Sindh', 'country': 'Pakistan', 'facility': 'Institute of Dentistry, Liaquat University of Medical and Health Sciences', 'geoPoint': {'lat': 25.39689, 'lon': 68.37718}}], 'overallOfficials': [{'name': 'Priya Rani, BDS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Liaquat University of Medical and Health Science'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Liaquat University of Medical & Health Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'FCPS Trainee', 'investigatorFullName': 'Sarang Suresh', 'investigatorAffiliation': 'Liaquat University of Medical & Health Sciences'}}}}