Ignite Creation Date:
2025-12-25 @ 2:55 AM
Ignite Modification Date:
2025-12-26 @ 1:36 AM
Study NCT ID:
NCT05376033
Status:
COMPLETED
Last Update Posted:
2022-05-17
First Post:
2022-05-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Outcome of Root Canal Treatments Obturated With Calcium Silicate Based Sealers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019553', 'term': 'Tooth, Nonvital'}], 'ancestors': [{'id': 'D003788', 'term': 'Dental Pulp Diseases'}, {'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012389', 'term': 'Root Canal Obturation'}], 'ancestors': [{'id': 'D012390', 'term': 'Root Canal Therapy'}, {'id': 'D004708', 'term': 'Endodontics'}, {'id': 'D003813', 'term': 'Dentistry'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 109}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2022-02-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-05-10', 'studyFirstSubmitDate': '2022-05-03', 'studyFirstSubmitQcDate': '2022-05-10', 'lastUpdatePostDateStruct': {'date': '2022-05-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-02-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Healing rate', 'timeFrame': '24 months', 'description': 'Periapical index minor than 3 at the endline'}], 'secondaryOutcomes': [{'measure': 'Survival rate', 'timeFrame': '24 months', 'description': 'presence of root canal treated tooth at the endline'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['root canal treatment', 'healing rate', 'warm obturation technique', 'bioceramic sealer'], 'conditions': ['Endodontically Treated Teeth']}, 'descriptionModule': {'briefSummary': 'The clinical use of a flowable premixed calcium-silicate bioceramic sealer used in association with warm carrier-based/single-cone technique will be compared with epoxy resin-based sealer with carrier-based technique.', 'detailedDescription': 'Healthy consecutive patients (n= 109) requiring 141 root canal treatments were enrolled in this study and divided in 3 groups (Group 1: Ceraseal + single cone cold technique n=47. Group 2: Ceraseal + Carrier-based technique n=47. Group 3 AH Plus + Carrier based technique n=47).\n\nPeriapical X-rays were taken preoperatively, after root canal filling and after 6, 12 and 24 months. Two evaluators blindly assessed the Periapical Index (PAI) and sealer extrusion in the 3 groups (k =0.90). Healing rate and survival rate were also analysed.\n\nChi square tests was used to analyse significant differences among the groups. Multilevel analysis was performed to analyse the factors associated to healing status and survival status.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. age 18-75 years\n2. no use of antiresorptive or antiangiogenic drug\n3. healthy status (ASA 1 or 2).\n4. Needing one or more root canal treatment\n\nExclusion Criteria:\n\n1. Teeth with less than 2 walls of structural integrity\n2. Wide apexes (\\>40 diameter)\n3. ASA \\> 3,\n4. Any pathology that could compromise bone healing or the immune response,\n5. pregnancy or breast feeding\n6. heavy smoking (\\>15 cigarettes/day), (Tverdal \\& Bjartveit 2006)\n7. exposure to radiation therapy focussed on the head and neck region and malignant disease directly involving the jaws.\n8. Lacks of occlusal contacts'}, 'identificationModule': {'nctId': 'NCT05376033', 'briefTitle': 'Outcome of Root Canal Treatments Obturated With Calcium Silicate Based Sealers', 'organization': {'class': 'OTHER', 'fullName': 'University of Bologna'}, 'officialTitle': 'Outcome of Root Canal Treatments Obturated With Calcium Silicate Based Sealers', 'orgStudyIdInfo': {'id': 'OUTENDOPROSP'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Premixed Sealer + Single cone', 'description': 'Premixed flowable hydraulic calcium silicate sealer was applied with a a K File #15 that was inserted into the canal to reach the WL - 3mm and gently moved around the root canal walls. Then, gutta-percha points were gently inserted at the WL -0.5mm and compacted with lateral condensation/vertical condensation.', 'interventionNames': ['Other: root canal filling with Ceraseal sealer']}, {'type': 'EXPERIMENTAL', 'label': 'Premixed Sealer + Thermafil', 'description': 'Premixed bioceramic sealer was applied and previously described. Pre-heated carrier was inserted in the canal at WL-0.5mm. The carrier excess was removed with a Thermacut bur.', 'interventionNames': ['Other: root canal filling with Ceraseal sealer']}, {'type': 'OTHER', 'label': 'Sealer + Thermafil', 'description': 'Epoxy-resin-based sealer was mixed and immediately inserted into the root canal using a K File #15. Pre-heated carrier was inserted in the canal at WL -0.5mm. The carriers excess was removed with a bur.', 'interventionNames': ['Other: root canal filling with Ceraseal sealer']}], 'interventions': [{'name': 'root canal filling with Ceraseal sealer', 'type': 'OTHER', 'description': 'root canal filling with Ceraseal sealer', 'armGroupLabels': ['Premixed Sealer + Single cone', 'Premixed Sealer + Thermafil', 'Sealer + Thermafil']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40125', 'city': 'Bologna', 'state': 'Emilia-Romagna', 'country': 'Italy', 'facility': 'Dental School University of Bologna', 'geoPoint': {'lat': 44.49381, 'lon': 11.33875}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Bologna', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'University of Bologna', 'investigatorFullName': 'Fausto Zamparini', 'investigatorAffiliation': 'University of Bologna'}}}}