Ignite Creation Date:
2025-12-24 @ 4:45 PM
Ignite Modification Date:
2025-12-29 @ 6:08 PM
Study NCT ID:
NCT05221450
Status:
RECRUITING
Last Update Posted:
2024-04-09
First Post:
2022-01-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Factors Affecting the Endodontic Treatment Outcome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010485', 'term': 'Periapical Periodontitis'}, {'id': 'D010484', 'term': 'Periapical Granuloma'}, {'id': 'D011842', 'term': 'Radicular Cyst'}], 'ancestors': [{'id': 'D010483', 'term': 'Periapical Diseases'}, {'id': 'D007571', 'term': 'Jaw Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D010518', 'term': 'Periodontitis'}, {'id': 'D010509', 'term': 'Periodontal Cyst'}, {'id': 'D009807', 'term': 'Odontogenic Cysts'}, {'id': 'D007570', 'term': 'Jaw Cysts'}, {'id': 'D001845', 'term': 'Bone Cysts'}, {'id': 'D003560', 'term': 'Cysts'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 700}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2008-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2028-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-07', 'studyFirstSubmitDate': '2022-01-22', 'studyFirstSubmitQcDate': '2022-01-22', 'lastUpdatePostDateStruct': {'date': '2024-04-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Treatment outcome based on strict combined radiographic and clinical criteria', 'timeFrame': '1-4 years postoperatively', 'description': 'Successful treatment outcome is defined as an absence of radiographic sign of apical periodontitis (periapical index PAI \\<= 2) and clinical signs of inflamation (swelling, sinus tract, tenderness to periapical palpation and percussion, pain) on follow-up examination 1-4 years postoperatively'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['root canal treatment', 'outcome', 'success'], 'conditions': ['Apical Periodontitis', 'Apical Granuloma', 'Apical Cyst']}, 'referencesModule': {'references': [{'pmid': '21366626', 'type': 'BACKGROUND', 'citation': 'Ng YL, Mann V, Gulabivala K. A prospective study of the factors affecting outcomes of nonsurgical root canal treatment: part 1: periapical health. Int Endod J. 2011 Jul;44(7):583-609. doi: 10.1111/j.1365-2591.2011.01872.x. Epub 2011 Mar 2.'}, {'pmid': '14686806', 'type': 'BACKGROUND', 'citation': 'Friedman S, Abitbol S, Lawrence HP. Treatment outcome in endodontics: the Toronto Study. Phase 1: initial treatment. J Endod. 2003 Dec;29(12):787-93. doi: 10.1097/00004770-200312000-00001.'}, {'pmid': '17180780', 'type': 'BACKGROUND', 'citation': 'European Society of Endodontology. Quality guidelines for endodontic treatment: consensus report of the European Society of Endodontology. Int Endod J. 2006 Dec;39(12):921-30. doi: 10.1111/j.1365-2591.2006.01180.x.'}, {'pmid': '17931389', 'type': 'BACKGROUND', 'citation': 'Ng YL, Mann V, Rahbaran S, Lewsey J, Gulabivala K. Outcome of primary root canal treatment: systematic review of the literature - part 1. Effects of study characteristics on probability of success. Int Endod J. 2007 Dec;40(12):921-39. doi: 10.1111/j.1365-2591.2007.01322.x. Epub 2007 Oct 10.'}, {'pmid': '17931388', 'type': 'BACKGROUND', 'citation': 'Ng YL, Mann V, Rahbaran S, Lewsey J, Gulabivala K. Outcome of primary root canal treatment: systematic review of the literature -- Part 2. Influence of clinical factors. Int Endod J. 2008 Jan;41(1):6-31. doi: 10.1111/j.1365-2591.2007.01323.x. Epub 2007 Oct 10.'}, {'pmid': '22099859', 'type': 'BACKGROUND', 'citation': 'Ricucci D, Russo J, Rutberg M, Burleson JA, Spangberg LS. A prospective cohort study of endodontic treatments of 1,369 root canals: results after 5 years. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2011 Dec;112(6):825-42. doi: 10.1016/j.tripleo.2011.08.003.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this prospective cohort observational study is: (i) to assess the endodontic treatment outcome in a private specialist endodontic office in Slovenia; (ii) to estimate the effect of various pre-, intra- and postoperative factors onto endodontic treatment outcome.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The sample population will include patients who are referred from a general dental practices in Slovenia to a private specialist endodontic practice for endodontic treatment, from the beginning of January 2008 on. All patients will be over 18 years of age at the beginning of the endodontic treatment and will attent a follow-up examination at least 1-4 years after endodontic treatment.\n\nTeeth will not be included in the study if (i) they have preoperative advanced periodontal disease, (ii) prior microsurgical root-end resection was performed, or (iii) the apex / apices of the tooth are not clearly discernible on any of the periapical radiographs.\n\nTeeth will be excluded from the study if (i) they will be extracted for non-endodontic reason or (ii) the patient will not attend a follow-up examination.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients referred to the private endodontic specialist office for endodontic treatment\n* written informed consent was obtained prior beginning of the treatment.\n\nExclusion Criteria:\n\n* preoperative advanced periodontal disease\n* prior microsurgical root-end resection performed\n* apices of the tooth were not clearly discernible on any of periapical radiographs\n* endodontic treated teeth were extracted for non-endodontic reason\n* the patient did not attend a follow-up examination.'}, 'identificationModule': {'nctId': 'NCT05221450', 'briefTitle': 'Factors Affecting the Endodontic Treatment Outcome', 'organization': {'class': 'OTHER', 'fullName': 'Odontos, Specialisticna Zobna Ambulanta, d.o.o.'}, 'orgStudyIdInfo': {'id': '0120-402/2019/5'}}, 'armsInterventionsModule': {'interventions': [{'name': 'primary endodontic treatment', 'type': 'PROCEDURE', 'otherNames': ['secondary endodontic treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1000', 'city': 'Ljubljana', 'status': 'RECRUITING', 'country': 'Slovenia', 'contacts': [{'name': 'Rok Juric, DMD', 'role': 'CONTACT', 'email': 'rok.juric@odontos.si', 'phone': '+386 1 2323231'}, {'name': 'Janja Jan, Prof.', 'role': 'CONTACT', 'phone': '+386 1 5222770'}, {'name': 'Rok Juric, DMD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Odontos, specialistična zobna ambulanta, d.o.o.', 'geoPoint': {'lat': 46.05108, 'lon': 14.50513}}], 'centralContacts': [{'name': 'Rok Juric, DMD', 'role': 'CONTACT', 'email': 'rok.juric@odontos.si', 'phone': '+386 1 2323231'}, {'name': 'Janja Jan, Prof.', 'role': 'CONTACT', 'phone': '+386 1 522 2770'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'CSR'], 'timeFrame': 'anonymised data will be available on request for 1 year after the publication of the study report', 'ipdSharing': 'YES', 'description': 'anonymised IPD that uderlie the results in the publication will we shared to other researcher on reasonable request', 'accessCriteria': 'contacting the principal investigator by e-mail'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Odontos, Specialisticna Zobna Ambulanta, d.o.o.', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Ljubljana, Faculty of Medicine', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}