Ignite Creation Date:
2025-12-25 @ 4:18 AM
Ignite Modification Date:
2026-01-04 @ 8:38 AM
Study NCT ID:
NCT03029520
Status:
COMPLETED
Last Update Posted:
2017-01-25
First Post:
2017-01-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Post-Obturation Pain Following the Use of the AH Plus and iRoot SP 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': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 160}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-24', 'studyFirstSubmitDate': '2017-01-11', 'studyFirstSubmitQcDate': '2017-01-20', 'lastUpdatePostDateStruct': {'date': '2017-01-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2017-01-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The incidence of postoperative pain by using VAS scale after obturation with different sealers.', 'timeFrame': '72 hour'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Endodontic Postoperative Pain', 'iRoot SP Sealer', 'Randomized Clinical Trial', 'Herofill carrier-based obturation'], 'conditions': ['Endodontically-Treated Teeth']}, 'descriptionModule': {'briefSummary': 'The aim of this study was to evaluate and compare postoperative pain and overextension of root canal filling after root canal treatment using a carrier-based obturation system and two different sealers.\n\nIn this prospective randomized clinical trial, 160 mandibular premolars and molars in 160 patients were treated. Patients with vital and devital teeth were assigned to four groups using a randomized block design with block sizes of 10 patients each. The groups were composed of devital teeth with periapical lesions treated with iRoot SP sealer, vital teeth treated with iRoot SP sealer, devital teeth with periapical lesions treated with AH Plus sealer, and vital teeth treated with AH Plus sealer. In single visits, a single operator prepared root canals and filled them with sealer using the carrier-based obturation technique. Radiographs were taken and obturation length was recorded. Patients recorded pain scores use of Visual Analogue Scale and frequency of analgesic intake at baseline and 0-6, 6-12, 12-24, and 24-72 h..', 'detailedDescription': 'This randomized controlled clinical study was conducted to compare the incidence and intensity of post-obturation pain, evaluate the overextension of filling material radiographically, and assess the relationship between pain and analgesic intake in patients with vital and devital teeth undergoing carrier-based obturation with two different sealers (iRoot SP, AH Plus)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* no systemic diseases\n* women were not pregnant or breastfeeding status\n* no history of taking analgesics in the previous seven days or other drugs prior to presenting for treatment.\n* all selected teeth were mandibular molar or mandibular premolar.\n\nExclusion Criteria:\n\n* systemic and/or periodontal disease;\n* allergy to local anesthetic agents and/or history of intolerance to nonsteroidal anti-inflammatory drugs;\n* requirement for antibiotic prophylaxis\n* open tooth apex\n* pacemaker use'}, 'identificationModule': {'nctId': 'NCT03029520', 'briefTitle': 'Post-Obturation Pain Following the Use of the AH Plus and iRoot SP Sealers', 'organization': {'class': 'OTHER', 'fullName': 'Cukurova University'}, 'officialTitle': 'Termoplastik Kor tekniğini Iki farklı Kanal patı Ile kullanıp Tedavi sonrası Hassasiyet ve kök Ucundan taşma miktarının değerlendirilmesi: Randomize kontrollü Klinik çalışma', 'orgStudyIdInfo': {'id': 'BAPKOM 4949'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'pain iRoot SP sealer Vital Pulp', 'description': 'Evaluation of Postoperative pain after root canal obturation with iRoot SP sealer (Innovative BioCeramix Inc., Vancouver, Canada) with patients who has (mandibular premolar/molar) vital pulp.', 'interventionNames': ['Other: Root canal obturation with iRoot SP sealer']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'pain iRoot SP sealer Devital pulp', 'description': 'Evaluation of Postoperative pain after root canal obturation with iRoot SP sealer (Innovative BioCeramix Inc., Vancouver, Canada) with patients who has (mandibular premolar/molar) devital pulp.', 'interventionNames': ['Other: Root canal obturation with iRoot SP sealer']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'pain AHPlus Vital pulp', 'description': 'Evaluation of Postoperative pain after root canal obturation with AH Plus sealer (Dentsply Maillefer, Ballaigues, Switzerland) with patients who has (mandibular premolar/molar) vital pulp.', 'interventionNames': ['Other: Root canal obturation with AH Plus Sealer']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'pain AHPlus Devital Pulp', 'description': 'Evaluation of Postoperative pain after root canal obturation with AH Plus sealer (Dentsply Maillefer, Ballaigues, Switzerland) with patients who has (mandibular premolar/molar) devital pulp.', 'interventionNames': ['Other: Root canal obturation with AH Plus Sealer']}], 'interventions': [{'name': 'Root canal obturation with iRoot SP sealer', 'type': 'OTHER', 'description': 'Postoperative pain after root canal obturation with iRoot SP sealer with patients who has (mandibular premolar/molar) vital and devital pulps.', 'armGroupLabels': ['pain iRoot SP sealer Devital pulp', 'pain iRoot SP sealer Vital Pulp']}, {'name': 'Root canal obturation with AH Plus Sealer', 'type': 'OTHER', 'description': 'Postoperative pain after root canal obturation with AH Plus sealer with patients who has (mandibular premolar/molar) vital and devital pulps.', 'armGroupLabels': ['pain AHPlus Devital Pulp', 'pain AHPlus Vital pulp']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'oguz yoldas, professor', 'role': 'STUDY_CHAIR', 'affiliation': 'vice dean'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'The study will be shared at Turkish Council of Higher education thesis center'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cukurova University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research assistant', 'investigatorFullName': 'Ayfer Atav Ateş', 'investigatorAffiliation': 'Cukurova University'}}}}