Ignite Creation Date:
2025-12-25 @ 4:06 AM
Ignite Modification Date:
2025-12-26 @ 3:03 AM
Study NCT ID:
NCT04399720
Status:
COMPLETED
Last Update Posted:
2020-05-27
First Post:
2020-05-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Root Canal Treatment Outcome in Patients Under Bisphosphonate Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059266', 'term': 'Bisphosphonate-Associated Osteonecrosis of the Jaw'}, {'id': 'D010482', 'term': 'Periapical Abscess'}, {'id': 'D019553', 'term': 'Tooth, Nonvital'}], 'ancestors': [{'id': 'D010020', 'term': 'Osteonecrosis'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D007571', 'term': 'Jaw Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D009336', 'term': 'Necrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D000038', 'term': 'Abscess'}, {'id': 'D013492', 'term': 'Suppuration'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D010485', 'term': 'Periapical Periodontitis'}, {'id': 'D010483', 'term': 'Periapical Diseases'}, {'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D010518', 'term': 'Periodontitis'}, {'id': 'D003788', 'term': 'Dental Pulp Diseases'}, {'id': 'D014076', 'term': 'Tooth Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 111}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-01-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2017-12-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-05-23', 'studyFirstSubmitDate': '2020-05-20', 'studyFirstSubmitQcDate': '2020-05-20', 'lastUpdatePostDateStruct': {'date': '2020-05-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-12-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'health patients', 'timeFrame': '5 years', 'description': 'assessment of periapical index (PAI)'}], 'secondaryOutcomes': [{'measure': 'Complications', 'timeFrame': '5 years', 'description': 'extraction periapical re exacerbation during before the endline ( 5 years)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['success rate', 'survival rate', 'endodontic treatment'], 'conditions': ['Root Canal Infection', 'Bisphosphonate-Associated Osteonecrosis', 'Periapical Abscess', 'Endodontically Treated Teeth']}, 'referencesModule': {'references': [{'pmid': '24908421', 'type': 'RESULT', 'citation': 'Pirani C, Chersoni S, Montebugnoli L, Prati C. Long-term outcome of non-surgical root canal treatment: a retrospective analysis. Odontology. 2015 May;103(2):185-93. doi: 10.1007/s10266-014-0159-0. Epub 2014 Jun 8.'}, {'pmid': '29432651', 'type': 'RESULT', 'citation': 'Prati C, Pirani C, Zamparini F, Gatto MR, Gandolfi MG. A 20-year historical prospective cohort study of root canal treatments. A Multilevel analysis. Int Endod J. 2018 Sep;51(9):955-968. doi: 10.1111/iej.12908. Epub 2018 Mar 7.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study was to evaluate the survival rate and healing time of compromised teeth and seriously compromised teeth that were endodontically treated in patients which received bisphosphonate therapy . Clinical complications, success and survival rate was reported. Mean clinical parameters, clinical symptoms and presence of periapical radilucency were recorded.', 'detailedDescription': 'The study was conducted in one University Endodontic Clinical Department - Dental School between January 2009 and December 2017.\n\nRoot canal treatment was performed according previously reported operative protocols.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '40 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Similar geographic provenience', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients affected by endodontic disease and able to attend a hygiene recall program\n\nExclusion Criteria:\n\n* inability to attend a recall hygien program'}, 'identificationModule': {'nctId': 'NCT04399720', 'briefTitle': 'Root Canal Treatment Outcome in Patients Under Bisphosphonate Therapy', 'organization': {'class': 'OTHER', 'fullName': 'University of Bologna'}, 'officialTitle': 'Root Canal Treatment of Compromised Teeth as Alternative Treatment in Patients Under Bisphosphonate Therapy: 60-month Results of a Prospective Clinical Study', 'orgStudyIdInfo': {'id': 'bifosfonendo'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'BPS group', 'description': 'patients under Bisphosphonate therapy for at least 24 months', 'interventionNames': ['Procedure: Root canal treatment']}, {'label': 'healthy patients', 'description': 'healthy patients not assuming with no previous Bisphosphonate assumption', 'interventionNames': ['Procedure: Root canal treatment']}], 'interventions': [{'name': 'Root canal treatment', 'type': 'PROCEDURE', 'description': 'Root canal treatment using a standard manual k file instrumentation and carrier-based root canal filling technique', 'armGroupLabels': ['BPS group', 'healthy patients']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Bologna', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'DDS,MS,PhD', 'investigatorFullName': 'Fausto Zamparini', 'investigatorAffiliation': 'University of Bologna'}}}}