Ignite Creation Date:
2025-12-24 @ 11:14 PM
Ignite Modification Date:
2026-01-01 @ 12:45 PM
Study NCT ID:
NCT05414656
Status:
UNKNOWN
Last Update Posted:
2022-06-10
First Post:
2022-06-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Clinical Trial of Composite Class II Restorations With Two Different Matrix Bands
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-05-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2022-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-06-08', 'studyFirstSubmitDate': '2022-06-02', 'studyFirstSubmitQcDate': '2022-06-08', 'lastUpdatePostDateStruct': {'date': '2022-06-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'proximal contacts tightness', 'timeFrame': 'immediately after procedure', 'description': 'The tightness of the proximal contact area resulting from Saddle contoured metal matrix and pre-contoured self-adhesive matrix . It was measured using a nine inch long nylon dental floss (Oral-B, USA).'}], 'secondaryOutcomes': [{'measure': 'Proximal contours and overhangs', 'timeFrame': 'immediately after procedure', 'description': 'To be examined clinically with an explorer and mouth mirror and then on the radiograph by the blinded co investigator.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Class II Caries in Posterior Teeth']}, 'referencesModule': {'references': [{'pmid': '38419215', 'type': 'DERIVED', 'citation': 'Sarwar N, Khokhar SA. Comparison of saddle contoured metal matrix and pre-contoured self-adhesive matrix in composite resin class II restorations; an in vivo study. J Pak Med Assoc. 2024 Feb;74(2):209-215. doi: 10.47391/JPMA.8627.'}]}, 'descriptionModule': {'briefSummary': 'Various procedures and techniques have been devised in an attempt to generate tighter and more anatomic proximal contacts with class II composite restorations. The investigators study focuses on using Saddle contoured metal matrix and pre-contoured self-adhesive matrix .Moreover, the investigators have attempted to study proximal tightness and proximal contours of composite restoration as separate variables.', 'detailedDescription': 'A total of 60 posterior teeth with proximal cavity to be assigned on alternate basis in two equal groups. Group A teeth received the Saddle contoured metal matrix and group B pre-contoured self-adhesive matrix after cavity preparation.\n\nAll teeth to be restored with Nano hybrid composite restorative material. Outcome of proximal contours and contact tightness is determined by a blinded assessor just after the restoration.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* • Permanent fully erupted teeth with class II supra-gingival caries or the necessity of replacing class II restoration.\n\n * The patient who has adjacent teeth available for the contact with surrounding tooth structure.\n * Teeth with cavity isthmus less than one-third of inter-cuspal distance\n\nExclusion Criteria:\n\n* • Partially erupted or deciduous teeth.\n\n * Teeth with orthodontic bands or brackets.\n * 3rd Molar and rotated teeth.\n * Teeth with dental caries extending up to pulp with periapical pathosis or periodontally weak teeth.'}, 'identificationModule': {'nctId': 'NCT05414656', 'briefTitle': 'A Clinical Trial of Composite Class II Restorations With Two Different Matrix Bands', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Pakistan Institute of Medical Sciences'}, 'officialTitle': 'Comparison of Saddle Contoured Metal Matrix and Pre-contoured Self-adhesive Matrix in Composite Resin Class II Restorations', 'orgStudyIdInfo': {'id': 'SOD/ERB/2022/02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group A : Saddle contoured metal matrix', 'description': 'The prepared teeth received the Saddle contoured metal matrix. The saddle clip of matrix connect the band and secured around prepared cavity wall. The anatomical wedge placed into the gingival embrasure to maintain the height of gingival floor and ensure the optimal adaptation of the matrix band in the cervical region.', 'interventionNames': ['Device: Saddle contoured metal matrix, Pre-contoured self-adhesive matrix']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group B:pre-contoured self-adhesive matrix', 'description': 'Teeth received the Pre-contoured self adhesive matrix with anatomical wedges. The adhesive end of band closed around the prepared cavity.', 'interventionNames': ['Device: Saddle contoured metal matrix, Pre-contoured self-adhesive matrix']}], 'interventions': [{'name': 'Saddle contoured metal matrix, Pre-contoured self-adhesive matrix', 'type': 'DEVICE', 'description': 'Saddle contoured metal matrix placed with the small clipper. The -contoured self-adhesive matrix has self adhesive ability.', 'armGroupLabels': ['Group A : Saddle contoured metal matrix', 'Group B:pre-contoured self-adhesive matrix']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Islamabad', 'state': 'Islamabad', 'status': 'RECRUITING', 'country': 'Pakistan', 'facility': 'School of Dentistry, Shaheed Zulfiqar Ali Bhutto Medical University, Islamabad', 'geoPoint': {'lat': 33.72148, 'lon': 73.04329}}], 'centralContacts': [{'name': 'Nosheen Sarwar, BDS', 'role': 'CONTACT', 'email': 'nosheensarwar48@gmail.com', 'phone': '+923088895652'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pakistan Institute of Medical Sciences', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principle Investigator', 'investigatorFullName': 'nosheen sarwar', 'investigatorAffiliation': 'Pakistan Institute of Medical Sciences'}}}}