Ignite Creation Date:
2025-12-25 @ 1:06 AM
Ignite Modification Date:
2026-02-25 @ 8:31 PM
Study NCT ID:
NCT04243993
Status:
UNKNOWN
Last Update Posted:
2020-01-28
First Post:
2019-12-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Outcomes of Bio-MA and ProRoot MTA in Endodontic Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003788', 'term': 'Dental Pulp Diseases'}], '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': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-01-26', 'studyFirstSubmitDate': '2019-12-24', 'studyFirstSubmitQcDate': '2020-01-26', 'lastUpdatePostDateStruct': {'date': '2020-01-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-01-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Healed rate', 'timeFrame': 'At least 1 year recall', 'description': 'No clinical sign and symptoms and periapical area in radiograph is normal. Describe in percentage.'}, {'measure': 'Healing rate', 'timeFrame': 'At least 1 year recall', 'description': 'No clinical sign and symptoms and periapical lesion in radiograph is reduce in size. Describe in percentage.'}, {'measure': 'Disease rate', 'timeFrame': 'At least 1 year recall', 'description': 'Clinical sign and symptoms is present and/or periapical lesion in radiograph is unchange or enlarge. Describe in percentage.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Clinical Outcome', 'Endodontic Disease']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the endodontic outcomes of Bio-MA and ProRoot MTA in pulpotomy, orthograde MTA apical barrier, root perforation repair, endodontic microsurgery.', 'detailedDescription': 'The patients were recruited at the Endodontic clinic, Faculty of Dentistry, Mahidol University, Thailand. Each treatment was provided following the standard protocol. The calcium silicate based material (Bio-MA or ProRoot MTA) was randomly selected and used in the treatment. The patients were periodically recalled at 6 to 12 months. The outcome of the three treatments based on the clinical and radiographic criteria was assessed by the calibrated examiners and interpreted as \'\'healed/healing" or \'\'disease.\'\''}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '10 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Teeth treated with pulpotomy, orthograde MTA apical barrier, root perforation repair or endodontic microsurgery\n\nExclusion Criteria:\n\n* Teeth with un-restorable condition\n* Teeth with crack or fracture\n* Teeth with external or internal root resorption\n* Teeth with chronic periodontitis with marginal bone loss more than 5 mm'}, 'identificationModule': {'nctId': 'NCT04243993', 'briefTitle': 'Clinical Outcomes of Bio-MA and ProRoot MTA in Endodontic Treatment', 'organization': {'class': 'OTHER', 'fullName': 'Mahidol University'}, 'officialTitle': 'Clinical Outcomes of Bio-MA and ProRoot MTA in Non-surgical and Surgical Endodontic Treatment: a Randomized Controlled Clinical Trial', 'orgStudyIdInfo': {'id': 'MU-DT/PY-IRB 2016/052.0310'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Bio-MA', 'description': 'Calcium silicate cement containing calcium chloride accelerator', 'interventionNames': ['Other: Calcium silicate cement']}, {'type': 'OTHER', 'label': 'ProRoot MTA', 'description': 'Calcium silicate cement without calcium chloride accelerator', 'interventionNames': ['Other: Calcium silicate cement']}], 'interventions': [{'name': 'Calcium silicate cement', 'type': 'OTHER', 'description': 'Calcium silicate cement for using in endodontic treatments i.e. pulpotomy, orthograde MTA apical barrier, root perforation repair, and endodontic microsurgery.', 'armGroupLabels': ['Bio-MA', 'ProRoot MTA']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10400', 'city': 'Bangkok', 'status': 'RECRUITING', 'country': 'Thailand', 'contacts': [{'name': 'Nuttida Tungsuksomboon, DDS', 'role': 'CONTACT', 'email': 'ntd_tssb@hotmail.com', 'phone': '022007622'}], 'facility': 'Nuttida Tungsuksomboon', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}], 'centralContacts': [{'name': 'Danuchit Banomyong, Ph.D.', 'role': 'CONTACT', 'email': 'danuchit.ban@mahidol.ac.th', 'phone': '022007622'}], 'overallOfficials': [{'name': 'Supachai Sutimuntanakul, TBOD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Mahidol University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mahidol University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}