Ignite Creation Date:
2025-12-25 @ 3:08 AM
Ignite Modification Date:
2025-12-26 @ 1:47 AM
Study NCT ID:
NCT04527705
Status:
RECRUITING
Last Update Posted:
2020-08-26
First Post:
2020-08-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Outcome of Endodontic Retreatment in One or Two Visits
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003788', 'term': 'Dental Pulp Diseases'}, {'id': 'D019553', 'term': 'Tooth, Nonvital'}], 'ancestors': [{'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 110}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-09-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2031-07-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-08-23', 'studyFirstSubmitDate': '2020-08-13', 'studyFirstSubmitQcDate': '2020-08-23', 'lastUpdatePostDateStruct': {'date': '2020-08-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical post-operative pain', 'timeFrame': 'Immediately post treatment', 'description': "VAS score (0-10) of patient' level of pain, from no pain to extreme pain"}, {'measure': 'Clinical post-operative pain', 'timeFrame': '4 hours post-treatment', 'description': "VAS score (0-10) of patient' level of pain, from no pain to extreme pain"}, {'measure': 'Clinical post-operative pain', 'timeFrame': '24 hours post treatment', 'description': "VAS score (0-10) of patient' level of pain, from no pain to extreme pain"}, {'measure': 'Clinical post-operative pain', 'timeFrame': '48 hours post treatment', 'description': "VAS score (0-10) of patient' level of pain, from no pain to extreme pain"}, {'measure': 'Clinical signs or symptoms of periapical disease 1', 'timeFrame': '1 year', 'description': 'Absence/presence of clinical signs or symptoms of periapical disease'}, {'measure': 'Clinical signs or symptoms of periapical disease 2', 'timeFrame': '2 years', 'description': 'Absence/presence of clinical signs or symptoms of periapical disease'}, {'measure': 'Clinical signs or symptoms of periapical disease 4', 'timeFrame': '4 years', 'description': 'Absence/presence of clinical signs or symptoms of periapical disease'}, {'measure': 'Clinical signs or symptoms of periapical disease 6', 'timeFrame': '6 years', 'description': 'Absence/presence of clinical signs or symptoms of periapical disease'}, {'measure': 'Clinical signs or symptoms of periapical disease 10', 'timeFrame': '10 years', 'description': 'Absence/presence of clinical signs or symptoms of periapical disease'}, {'measure': 'Radiographic periapical absence/presence of radiographic apical periodontitis', 'timeFrame': '1 year', 'description': 'Absence/presence of radiographic apical periodontitis + PAI changes when compared with post-treatment radiograph'}, {'measure': 'Radiographic periapical absence/presence/changes in radiographic apical periodontitis', 'timeFrame': '2 years', 'description': 'Absence/presence of radiographic apical periodontitis + PAI changes when compared with post-treatment radiograph'}, {'measure': 'Radiographic periapical absence/presence/changes in radiographic apical periodontitis', 'timeFrame': '4 years', 'description': 'Absence/presence of radiographic apical periodontitis + PAI changes when compared with post-treatment radiograph'}, {'measure': 'Radiographic periapical absence/presence/changes in radiographic apical periodontitis', 'timeFrame': '6 years', 'description': 'Absence/presence of radiographic apical periodontitis + PAI changes when compared with post-treatment radiograph'}, {'measure': 'Radiographic periapical absence/presence/changes in radiographic apical periodontitis', 'timeFrame': '10 years', 'description': 'Absence/presence of radiographic apical periodontitis + PAI changes when compared with post-treatment radiograph'}], 'secondaryOutcomes': [{'measure': 'Correlation of prognostic factors and clinical signs or symptoms of periapical disease 1', 'timeFrame': '1 year', 'description': 'Correlation of pre-treatment symptomatology, post-operative pain, radiographic periapical lesion size, being an abutment, and presence of antagonist, in relation to having clinical signs or symptoms of periapical disease'}, {'measure': 'Correlation of prognostic factors and clinical signs or symptoms of periapical disease 2', 'timeFrame': '2 years', 'description': 'Correlation of pre-treatment symptomatology, post-operative pain, radiographic periapical lesion size, being an abutment, and presence of antagonist, in relation to having clinical signs or symptoms of periapical disease'}, {'measure': 'Correlation of prognostic factors and clinical signs or symptoms of periapical disease 4', 'timeFrame': '4 years', 'description': 'Correlation of pre-treatment symptomatology, post-operative pain, radiographic periapical lesion size, being an abutment, and presence of antagonist, in relation to having clinical signs or symptoms of periapical disease'}, {'measure': 'Correlation of prognostic factors and clinical signs or symptoms of periapical disease 6', 'timeFrame': '6 years', 'description': 'Correlation of pre-treatment symptomatology, post-operative pain, radiographic periapical lesion size, being an abutment, and presence of antagonist, in relation to having clinical signs or symptoms of periapical disease'}, {'measure': 'Correlation of prognostic factors and clinical signs or symptoms of periapical disease 10', 'timeFrame': '10 years', 'description': 'Correlation of pre-treatment symptomatology, post-operative pain, radiographic periapical lesion size, being an abutment, and presence of antagonist, in relation to having clinical signs or symptoms of periapical disease'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Primary root canal treatment', 'Secondary root canal treatment', 'Periapical healing', 'Outcome'], 'conditions': ['Endodontic Disease', 'Endodontically Treated Teeth', 'Root Canal Infection']}, 'descriptionModule': {'briefSummary': 'This study is a prospective randomized controlled study of patients who come to the University and non-surgical root canal retreatment is considered as the election of choice in presence of periapical disease. The aim is to evaluate the success rate of non-surgical retreatment performed in one compared to two visit treatment up to 10 years of follow-up. The null hypothesis is that there will be no statistically significant differences in rates of success, when performing root canal non-surgical retreatment in one or two visits.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients that demonstrate understanding of the study and willingness to participate as evidenced by signing the voluntary informed consent and received a signed and dated copy of the informed consent form.\n* Understands and is willing to comply with all study procedures and restrictions.\n* Not presence of clinically significant and relevant abnormalities of clinical history or oral examination.\n* Retreatment cases due to an endodontic failure.\n* Diagnosis of apical periodontitis.\n* Single or bi-radicular teeth.\n\nExclusion Criteria:\n\n* General: Patients with systemic diseases, diabetes, immunocompromised and pregnant women, or any clinically significant or relevant oral abnormalities.\n* Specific: root resorption, root fractures, impossibility of restoration and cases were secondary root canal treatment is not the treatment of choice.'}, 'identificationModule': {'nctId': 'NCT04527705', 'briefTitle': 'Outcome of Endodontic Retreatment in One or Two Visits', 'organization': {'class': 'OTHER', 'fullName': 'Universitat Internacional de Catalunya'}, 'officialTitle': 'Clinical and Radiographic Outcome of Endodontic Retreatment in One or Two Visits: A Randomized Controlled Trial.', 'orgStudyIdInfo': {'id': 'UICENDECL201501'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1-vist endodontic retreatment', 'description': 'Non-surgical root canal retreatment performed in one visit', 'interventionNames': ['Procedure: Non-surgical root canal retreatment']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2-vist endodontic retreatment', 'description': 'Non-surgical root canal retreatment performed in two visits', 'interventionNames': ['Procedure: Non-surgical root canal retreatment']}], 'interventions': [{'name': 'Non-surgical root canal retreatment', 'type': 'PROCEDURE', 'description': 'Non-surgical root canal retreatment', 'armGroupLabels': ['1-vist endodontic retreatment', '2-vist endodontic retreatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08195', 'city': 'Sant Cugat del Vallès', 'state': 'Barcelona', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Juan G. Olivieri, DDS, PhD', 'role': 'CONTACT', 'email': 'jgolivieri@uic.es', 'phone': '935042000'}], 'facility': 'Universitat Internacional de Catalunya', 'geoPoint': {'lat': 41.47063, 'lon': 2.08611}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitat Internacional de Catalunya', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Juan Gonzalo Olivieri', 'investigatorAffiliation': 'Universitat Internacional de Catalunya'}}}}