Ignite Creation Date:
2025-12-24 @ 5:03 PM
Ignite Modification Date:
2026-01-04 @ 3:53 AM
Study NCT ID:
NCT04691050
Status:
COMPLETED
Last Update Posted:
2020-12-31
First Post:
2020-12-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Endodontic Management of Primary Molars
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': 'C086631', 'term': 'mineral trioxide aggregate'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 13}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-01-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2020-06-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-12-30', 'studyFirstSubmitDate': '2020-12-25', 'studyFirstSubmitQcDate': '2020-12-30', 'lastUpdatePostDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-11-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical success rate', 'timeFrame': '3 months after root canal treatment', 'description': 'Clinical evaluation of root canal treatment was performed 3 months after treatment using the present clinical criteria. The treatment was decided a clinical success if the tooth fulfilled the following criteria:(1) continued function of the tooth without recurrence of infection; (2) no sensitivity on percussion and palpation; and (3) healthy soft tissues without fistula, abscess, and inflammation of the gums.'}, {'measure': 'Radiographic success rate', 'timeFrame': '3 months after root canal treatment', 'description': 'Radiographic evaluation of root canal treatment was performed 3 months after treatment using periapical radiograhps. The treatment was decided to be radiographically successful if it demonstrated the following criteria: (1) decreased radiolucency in the furcation or periradicular region, (2) absence of a new lesion formation.'}, {'measure': 'Clinical success rate', 'timeFrame': '6 months after root canal treatment', 'description': 'Clinical evaluation of root canal treatment was performed 6 months after treatment using the present clinical criteria. The treatment was decided a clinical success if the tooth fulfilled the following criteria:(1) continued function of the tooth without recurrence of infection; (2) no sensitivity on percussion and palpation; and (3) healthy soft tissues without fistula, abscess, and inflammation of the gums.'}, {'measure': 'Radiographic success rate', 'timeFrame': '6 months after root canal treatment', 'description': 'Radiographic evaluation of root canal treatment was performed 6 months after treatment using periapical radiograhps. The treatment was decided to be radiographically successful if it demonstrated the following criteria: (1) decreased radiolucency in the furcation or periradicular region, (2) absence of a new lesion formation.'}, {'measure': 'Clinical success rate', 'timeFrame': '9 months after root canal treatment', 'description': 'Clinical evaluation of root canal treatment was performed 9 months after treatment using the present clinical criteria. The treatment was decided a clinical success if the tooth fulfilled the following criteria:(1) continued function of the tooth without recurrence of infection; (2) no sensitivity on percussion and palpation; and (3) healthy soft tissues without fistula, abscess, and inflammation of the gums.'}, {'measure': 'Radiographic success rate', 'timeFrame': '9 months after root canal treatment', 'description': 'Radiographic evaluation of root canal treatment was performed 9 months after treatment using periapical radiograhps. The treatment was decided to be radiographically successful if it demonstrated the following criteria: (1) decreased radiolucency in the furcation or periradicular region, (2) absence of a new lesion formation.'}, {'measure': 'Clinical success rate', 'timeFrame': '12 months after root canal treatment', 'description': 'Clinical evaluation of root canal treatment was performed 12 months after treatment using the present clinical criteria. The treatment was decided a clinical success if the tooth fulfilled the following criteria:(1) continued function of the tooth without recurrence of infection; (2) no sensitivity on percussion and palpation; and (3) healthy soft tissues without fistula, abscess, and inflammation of the gums.'}, {'measure': 'Radiographic success rate', 'timeFrame': '12 months after root canal treatment', 'description': 'Radiographic evaluation of root canal treatment was performed 12 months after treatment using periapical radiograhps. The treatment was decided to be radiographically successful if it demonstrated the following criteria: (1) decreased radiolucency in the furcation or periradicular region, (2) absence of a new lesion formation.'}], 'secondaryOutcomes': [{'measure': 'Change of fractal dimension', 'timeFrame': '12 months after root canal treatment', 'description': 'The fractal dimension value of the furcation area between before treatment and 12 months after treatment were compared.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Primary teeth', 'Root canal filling', 'Fractal analysis'], 'conditions': ['Endodontically Treated Teeth']}, 'referencesModule': {'references': [{'pmid': '26534871', 'type': 'BACKGROUND', 'citation': 'Bezgin T, Ozgul BM, Arikan V, Sari S. Root canal filling in primary molars without successors: Mineral trioxide aggregate versus gutta-percha/AH-Plus. Aust Endod J. 2016 Aug;42(2):73-81. doi: 10.1111/aej.12132. Epub 2015 Nov 4.'}, {'pmid': '11716086', 'type': 'BACKGROUND', 'citation': "O'Sullivan SM, Hartwell GR. Obturation of a retained primary mandibular second molar using mineral trioxide aggregate: a case report. J Endod. 2001 Nov;27(11):703-5. doi: 10.1097/00004770-200111000-00013."}, {'pmid': '20415918', 'type': 'BACKGROUND', 'citation': 'Tunc ES, Bayrak S. Usage of white mineral trioxide aggregate in a non-vital primary molar with no permanent successor. Aust Dent J. 2010 Mar;55(1):92-5. doi: 10.1111/j.1834-7819.2009.01181.x.'}, {'pmid': '28179938', 'type': 'BACKGROUND', 'citation': 'Asgary S, Fazlyab M. Endodontic Management of an Infected Primary Molar in a Child with Agenesis of the Permanent Premolar. Iran Endod J. 2017 Winter;12(1):119-122. doi: 10.22037/iej.2017.25.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study was to describe the clinical and radiological outcome of root canal treatment with OrthoMTA in primary second molars without successors in which traditional root canal treatment with gutta-percha could not be performed.', 'detailedDescription': 'The study included 13 primary mandibular second molars with infected pulp and congenitally missing second premolars in which traditional root canal treatment with gutta-percha was contraindicated. Pulpectomy was performed in each tooth and the canals were filled with OrthoMTA. The clinical and radiological outcomes of the treatment were evaluated at 3, 6, 9, and 12 months. Fractal analysis was used to detect changes in the trabecular bone after the treatment. Repeated measures analysis of variance test and two independent t-tests were used to evaluate the data.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '14 Years', 'minimumAge': '8 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Selected to be preserved after an orthodontic consultation\n* Absence of permanent tooth germ under second primary molars\n* Sensitivity to percussion and palpation, complaints of spontaneous or persistent pain\n* Presence of irreversible pulpitis or pulp necrosis, and abscess or fistula, presence of pathological mobility,\n* Presence of internal and external pathological root resorption\n* Furcal lesions\n* Presence of infection exceeding 1/3 of the root\n* Pathological loss of substantial bone support\n* Loss of periodontal attachment\n* Contraindication of traditional root canal treatment\n\nExclusion Criteria:\n\n* Presence of any systemic disorder\n* Presence of any syndrome\n* A history or suspicion of allergies\n* Age \\<7 years,\n* Teeth selected to be extracted after an orthodontic consultation\n* A score of 1(-) or 2(--) according to the Frankl Behavior Scale\n* Parents who refused treatment, children who refused to receive the intended treatment once it was initiated'}, 'identificationModule': {'nctId': 'NCT04691050', 'briefTitle': 'Endodontic Management of Primary Molars', 'organization': {'class': 'OTHER', 'fullName': 'Tokat Gaziosmanpasa University'}, 'officialTitle': 'Clinical and Radiologic Evaluation of Root Canal Filling With OrthoMTA in Primary Molars Without Successors', 'orgStudyIdInfo': {'id': '19-KAEK-103'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'OrthoMta (BioMTA)', 'description': 'OrthoMTA was applied in primary molars without successors', 'interventionNames': ['Procedure: OrthoMTA (BioMTA)']}], 'interventions': [{'name': 'OrthoMTA (BioMTA)', 'type': 'PROCEDURE', 'description': 'Primary second molars without successors in which traditional root canal treatment with gutta-percha could not be performed was treated with OrthoMTA', 'armGroupLabels': ['OrthoMta (BioMTA)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60230', 'city': 'Tokat Province', 'country': 'Turkey (Türkiye)', 'facility': 'Tokat Gaziosmanpasa Univercity', 'geoPoint': {'lat': 40.31389, 'lon': 36.55444}}], 'overallOfficials': [{'name': 'Sümeyra Akkoç, Asst Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kutahya Health Sciences University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tokat Gaziosmanpasa University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Proffessor', 'investigatorFullName': 'Sümeyra Akkoç', 'investigatorAffiliation': 'Tokat Gaziosmanpasa University'}}}}