Ignite Creation Date:
2025-12-25 @ 12:40 AM
Ignite Modification Date:
2025-12-30 @ 12:50 PM
Study NCT ID:
NCT06092567
Status:
COMPLETED
Last Update Posted:
2023-10-23
First Post:
2023-09-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Post-operative Sensitivity in Composite Restorations
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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'This is a double-blinded study in which the participant and the outcome assessor masked.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'In this study, participants allocated in two groups by Consecutive non-random sampling technique'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-12-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2023-07-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-10-14', 'studyFirstSubmitDate': '2023-09-30', 'studyFirstSubmitQcDate': '2023-10-14', 'lastUpdatePostDateStruct': {'date': '2023-10-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Post-operative sensitivity in composite resin restoration', 'timeFrame': 'Two weeks', 'description': 'Evaluation of post-restorative sensitivity in composite restorations using Visual analogue scale score with scoring from 0 to 10. Score 0 (none), 1 to 3 (mild), 4 to 6 (moderate), and 7 to 10 (severe).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Class II Dental Caries', 'Sensitivity, Tooth']}, 'referencesModule': {'references': [{'pmid': '31592052', 'type': 'BACKGROUND', 'citation': 'Afifi SMH, Haridy MF, Farid MR. Evaluation of Post-Operative Sensitivity of Bulk Fill Resin Composite versus Nano Resin Composite: A Randomized Controlled Clinical Study. Open Access Maced J Med Sci. 2019 Jul 26;7(14):2335-2342. doi: 10.3889/oamjms.2019.656. eCollection 2019 Jul 30.'}, {'pmid': '31531552', 'type': 'BACKGROUND', 'citation': 'Tardem C, Albuquerque EG, Lopes LS, Marins SS, Calazans FS, Poubel LA, Barcelos R, Barceleiro MO. Clinical time and postoperative sensitivity after use of bulk-fill (syringe and capsule) vs. incremental filling composites: a randomized clinical trial. Braz Oral Res. 2019 Sep 16;33(0):e089. doi: 10.1590/1807-3107bor-2019.vol33.0089.'}]}, 'descriptionModule': {'briefSummary': 'Participants will be divided into groups. In group A, Composite restoration done using oblique incremental technique. In group B, Bulk-fill technique was used. VAS scoring to evaluate the primary outcome at one day, one week and two weeks.', 'detailedDescription': 'After the approval from ethical research committee, a written informed consent taken. Participants were briefed about the intervention with its associated merits and demerits. The restorative procedures were accomplished under rubber dam isolation using adequate local anesthesia. The principles of minimally intervention and adhesive dentistry were employed. Participants were allocated into two groups. In group A, restorative interventive was performed using Oblique incremental placement while in group B, Bulk-fill technique was used. Post-operative sensitivity was recorded at one day, one week and two week follow up using a Visual analogue scale.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Minimum 18 years of age with good general health\n* Vital and Periodontally stable teeth\n* Class-II primary carious lesions with a cavity depth of 3 to 5 mm\n* Established contact with adjacent and opposing natural or prosthetic teeth\n* Prior defective restorations in need of replacement (secondary caries, marginal fractures, and marginal staining)\n\nExclusion Criteria:\n\n* Teeth with a history of spontaneous pain\n* Compromised oral health status\n* Patients with parafunctional habits or temporomandibular disorders\n* Previously endodontically treated teeth or evidence of associated periapical/periodontal pathosis\n* Participants with a drug history of using anti-inflammatory, analgesics, or psychotropic medications within the last 2 weeks'}, 'identificationModule': {'nctId': 'NCT06092567', 'briefTitle': 'Post-operative Sensitivity in Composite Restorations', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Pakistan Institute of Medical Sciences'}, 'officialTitle': 'Post-operative Sensitivity in Composites Using Bulk-fill vs. Oblique Incremental Placement Technique: a Double-blind, Randomized Trial', 'orgStudyIdInfo': {'id': 'SOD/ERB/2022/04'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group A (Oblique Incremental Placement Techniique)', 'description': 'In this interventional group, a Nanohybrid composite resin Nexcomp (Meta Biomed, Korea) was placed using an oblique incremental technique with increments not exceeding 2 mm in thickness.', 'interventionNames': ['Procedure: Group A ( Oblique Incremental Placement Technique)']}, {'type': 'EXPERIMENTAL', 'label': 'Group B (Bulk-fill Placement Technique)', 'description': 'In this group, a composite Beautifil-Bulk Restorative (SHOFU dental) was utilized for restorative purposes using a bulk-fill technique with a thickness of 4 mm.', 'interventionNames': ['Procedure: Group B (Bulk-fill Placement technique)']}], 'interventions': [{'name': 'Group A ( Oblique Incremental Placement Technique)', 'type': 'PROCEDURE', 'description': 'In this interventional group, a Nanohybrid composite resin Nexcomp (Meta Biomed, Korea) was placed using an oblique incremental technique with increments not exceeding 2 mm in thickness.', 'armGroupLabels': ['Group A (Oblique Incremental Placement Techniique)']}, {'name': 'Group B (Bulk-fill Placement technique)', 'type': 'PROCEDURE', 'description': 'In this group, a composite Beautifil-Bulk Restorative (SHOFU dental) was utilized for restorative purposes using a bulk-fill technique with a thickness of 4 mm', 'armGroupLabels': ['Group B (Bulk-fill Placement Technique)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Islamabad', 'country': 'Pakistan', 'facility': 'School of Dentistry, Shaheed Zulfiqar Ali Bhutto Medical University', 'geoPoint': {'lat': 33.72148, 'lon': 73.04329}}], 'overallOfficials': [{'name': 'Nehal Amir, BDS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Pakistan Institute of Medical Sciences'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pakistan Institute of Medical Sciences', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'NEHAL AMIR', 'investigatorAffiliation': 'Pakistan Institute of Medical Sciences'}}}}