Ignite Creation Date:
2025-12-24 @ 12:15 PM
Ignite Modification Date:
2025-12-25 @ 9:33 PM
Study NCT ID:
NCT07152561
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-03
First Post:
2025-08-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Different Luting Cements for Pediatric Zirconia Crowns
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D019279', 'term': 'Resin Cements'}], 'ancestors': [{'id': 'D012117', 'term': 'Resins, Synthetic'}, {'id': 'D010969', 'term': 'Plastics'}, {'id': 'D011108', 'term': 'Polymers'}, {'id': 'D046911', 'term': 'Macromolecular Substances'}, {'id': 'D003738', 'term': 'Dental Cements'}, {'id': 'D003764', 'term': 'Dental Materials'}, {'id': 'D001697', 'term': 'Biomedical and Dental Materials'}, {'id': 'D008420', 'term': 'Manufactured Materials'}, {'id': 'D013676', 'term': 'Technology, Industry, and Agriculture'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-08-28', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2026-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-26', 'studyFirstSubmitDate': '2025-08-26', 'studyFirstSubmitQcDate': '2025-08-26', 'lastUpdatePostDateStruct': {'date': '2025-09-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-08-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Retention', 'timeFrame': '1 week, 1 month, 3 months, 6 months, 9 months, and 12 months', 'description': 'Retention will be assessed by visual inspection and probe to detect debonded crowns.'}, {'measure': 'Fracture', 'timeFrame': '1 week, 1 month, 3 months, 6 months, 9 months, and 12 months', 'description': 'Fractures will be assessed using visual inspection to detect incomplete fracture lines or complete fractures with loss of crown material.'}], 'secondaryOutcomes': [{'measure': 'The gingival condition', 'timeFrame': '1 week, 1 month, 3 months, 6 months, 9 months, and 12 months', 'description': 'The gingival condition around cemented crowns will be assessed by calculating the gingival index for each crowned tooth.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dental Caries in Children']}, 'descriptionModule': {'briefSummary': 'The study aims to compare the efficacy of using bioactive cement versus resin-cement for cementation of anterior pediatric zirconia crowns.', 'detailedDescription': '* For the bioactive cement group (Predicta® Bioactive Cement), the prepared tooth will be dried using compressed air but not desiccated. Cement will be dispensed through the auto-mixtip directly into the crown, and the crown will be properly positioned over the tooth; cement will be allowed to self-set for 20 seconds while maintaining gentle pressure on the crown. Buccal and lingual margins will be flash-cured for 10 seconds each using a light-curing unit to immediately cure the excess cement for easier removal, and buccal and lingual surfaces will then be light-cured for an extra 10 seconds each.\n* For the resin-cement group, the tooth will be dried with compressed air but not desiccated. The sealant will be applied with the syringe; then, the crown will be appropriately positioned over the tooth, and cement will be allowed to self-set for 2 minutes and cured while maintaining gentle pressure on the crown. Excess cement will be removed before the cement is completely set.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '5 Years', 'minimumAge': '3 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who had no history of allergies\n* Children who had at least two carious primary incisors.\n* Teeth with multi-surface carious lesion.\n* Teeth with no percussion or palpation sensitivity\n* Teeth with no abscess and/or fistula\n* Teeth with no prior pulpal treatment\n* Teeth with no mobility or signs of periodontal disease\n\nExclusion Criteria:\n\n* Children with congenital developmental defects (such as amelogenesis imperfecta and dentinogenesis imperfecta)\n* Children with a history of bruxism, trauma or infraocclusion\n* Children with a skeletal or dental malocclusion'}, 'identificationModule': {'nctId': 'NCT07152561', 'briefTitle': 'Different Luting Cements for Pediatric Zirconia Crowns', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Effect of Two Different Luting Cements on Clinical Outcomes of Pediatric Zirconia Crowns: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'Pediatric Zirconia Crowns'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm 1', 'description': 'Zirconia crown cemented with Predicta® Bioactive Cement', 'interventionNames': ['Drug: Zirconia crown cemented with Predicta® Bioactive Cement']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Arm 2', 'description': 'Zirconia crown cemented with resin-cement', 'interventionNames': ['Drug: Zirconia crown cemented with resin-cement']}], 'interventions': [{'name': 'Zirconia crown cemented with Predicta® Bioactive Cement', 'type': 'DRUG', 'description': '• For the bioactive cement group (Predicta® Bioactive Cement), the prepared tooth will be dried using compressed air but not desiccated. Cement will be dispensed through the auto-mixtip directly into the crown, and the crown will be properly positioned over the tooth; cement will be allowed to self-set for 20 seconds while maintaining gentle pressure on the crown. Buccal and lingual margins will be flash-cured for 10 seconds each using a light-curing unit to immediately cure the excess cement for easier removal, and buccal and lingual surfaces will then be light-cured for an extra 10 seconds each.', 'armGroupLabels': ['Arm 1']}, {'name': 'Zirconia crown cemented with resin-cement', 'type': 'DRUG', 'description': '• For the resin-cement group, the tooth will be dried with compressed air but not desiccated. The sealant will be applied with the syringe; then, the crown will be appropriately positioned over the tooth, and cement will be allowed to self-set for 2 minutes and cured while maintaining gentle pressure on the crown. Excess cement will be removed before the cement is completely set.', 'armGroupLabels': ['Arm 2']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Pediatric Dentistry and Dental Public Health', 'investigatorFullName': 'Rasha Mohamed Hatem Hanafy', 'investigatorAffiliation': 'Cairo University'}}}}