Ignite Creation Date:
2025-12-24 @ 11:52 PM
Ignite Modification Date:
2025-12-25 @ 9:47 PM
Study NCT ID:
NCT03522051
Status:
COMPLETED
Last Update Posted:
2021-09-16
First Post:
2018-04-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Assessment of Pulpotomy Procedure Using NeoMTA Plus in Permanent Teeth With Carious Exposure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011671', 'term': 'Pulpitis'}], 'ancestors': [{'id': 'D003788', 'term': 'Dental Pulp Diseases'}, {'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-10-10', 'size': 582277, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2018-04-24T06:42', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Patients with symptomatic deep caries in a permanent molar tooth will receive pulpotomy treatment and placement of a calcium silicate based material (Neo MTA plus) over the pulp and followed by restoration.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 109}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2021-08-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-09-15', 'studyFirstSubmitDate': '2018-04-19', 'studyFirstSubmitQcDate': '2018-04-29', 'lastUpdatePostDateStruct': {'date': '2021-09-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-05-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in pain symptoms', 'timeFrame': '2-3 days after the treatment, 3 months, 6 months and 12 months and afterwards up to 5 years.', 'description': 'The patient is anticipated to report reduction in the pain score after receiving the treatment within 2-3 days and the tooth should continue to be asymptomatic at follow up appointments. The patient will be asked to score the pain level on visual analogue scale using a score from 0-10. The zero is no pain while 10 is the maximum level.'}], 'secondaryOutcomes': [{'measure': 'Periapical normalcy at follow up radiographs .', 'timeFrame': '6months , 1 year, 2, 3,4,5 years', 'description': 'Pr-existing pathology should heal within 6 months- 1 year and normalcy should be maintained after ward up to 5 years.\n\nno emerging pathosis should be evident in the roots or surrounding bone.'}, {'measure': 'The tooth and restoration should be present in the mouth', 'timeFrame': '3, 6 months, 1 year, 2, 3,4,5 years', 'description': 'The tooth should be in the mouth and in function (not extracted) with an intact restoration at the follow up times'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['teeth', 'pulpitis', 'deep caries', 'pulpotomy', 'Mineral Trioxide Aggregate (MTA)'], 'conditions': ['Pulpotomy']}, 'referencesModule': {'references': [{'pmid': '29397003', 'type': 'BACKGROUND', 'citation': 'Taha NA, Abdelkhader SZ. Outcome of full pulpotomy using Biodentine in adult patients with symptoms indicative of irreversible pulpitis. Int Endod J. 2018 Aug;51(8):819-828. doi: 10.1111/iej.12903. Epub 2018 Feb 27.'}, {'pmid': '28673494', 'type': 'BACKGROUND', 'citation': 'Taha NA, Khazali MA. Partial Pulpotomy in Mature Permanent Teeth with Clinical Signs Indicative of Irreversible Pulpitis: A Randomized Clinical Trial. J Endod. 2017 Sep;43(9):1417-1421. doi: 10.1016/j.joen.2017.03.033. Epub 2017 Jun 30.'}, {'pmid': '26715408', 'type': 'BACKGROUND', 'citation': 'Taha NA, Ahmad MB, Ghanim A. Assessment of Mineral Trioxide Aggregate pulpotomy in mature permanent teeth with carious exposures. Int Endod J. 2017 Feb;50(2):117-125. doi: 10.1111/iej.12605. Epub 2016 Jan 30.'}]}, 'descriptionModule': {'briefSummary': 'Many deep carious teeth are treated unnecessarily by root canal therapy, while with using current techniques and advances in compatible dental materials in addition to better understanding of biological response of the dental pulp, many can be treated conservatively via vital pulp therapy procedures.', 'detailedDescription': 'Vital pulp therapy is recommended for teeth diagnosed with reversible pulpitis or partially inflamed pulps in which the remaining healthy tissue can be conserved and protected by a biologically active material to generate a hard tissue barrier that seals and protects the pulp from future microbial insult.\n\nThe aim of this in vivo study is to clinically and radiographically assess the outcome of full pulpotomy using a calcium silicate based material (NeoMTA Plus) in permanent teeth with carious exposure.\n\nEthics approval was obtained from the institutional ethics and research committee, and the patients were informed about details of the treatment and the possible complications. An informed consent was obtained. 120 patients meeting the inclusion criteria will be selected for this study and they will be subsequently followed up clinically and radiographically after 3 months, 6 months, 1 year and yearly afterward for 5 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '7 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Permanent teeth with mature or immature apices\n* Have no significant medical problems\n* The tooth should give positive response to cold test and electric pulp test (EPT)\n* Probing pocket depth and mobility within normal limits\n* No Signs of pulp necrosis including sinus tract or swelling\n* Radiographically ; caries either exposing the pulps or reaching more than 2\\\\3 the distance from the dentino-enamel junction (DEJ) to the pulp\n* The tooth can be restored via direct restoration\n\nExclusion Criteria:\n\n* Medically compromised patients\n* Negative response to cold test\n* Mobility\n* Sinus tract\n* Swelling\n* Non restorable teeth or badly broken teeth'}, 'identificationModule': {'nctId': 'NCT03522051', 'acronym': 'PULPOTOMY', 'briefTitle': 'Assessment of Pulpotomy Procedure Using NeoMTA Plus in Permanent Teeth With Carious Exposure', 'organization': {'class': 'OTHER', 'fullName': 'Jordan University of Science and Technology'}, 'officialTitle': 'Assessment of Pulpotomy Procedure Using NeoMTA Plus in Permanent Teeth With Carious Exposure', 'orgStudyIdInfo': {'id': 'JUST14-4-2018'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Patients with carious teeth', 'description': 'female or male patients with permanent teeth and deep caries will receive pulpotomy treatment and dressing with calcium silicate based material (Neo MTA plus material) followed by restoration.', 'interventionNames': ['Other: calcium silicate based material,']}], 'interventions': [{'name': 'calcium silicate based material,', 'type': 'OTHER', 'otherNames': ['Neo MTA plus, Avalon Biomed'], 'description': 'Its a dental pulp capping material which is biocompatable and induces hard tissue barrier formation', 'armGroupLabels': ['Patients with carious teeth']}]}, 'contactsLocationsModule': {'locations': [{'zip': '22110', 'city': 'Irbid', 'country': 'Jordan', 'facility': 'Jordan University of science and technology', 'geoPoint': {'lat': 32.55556, 'lon': 35.85}}], 'overallOfficials': [{'name': 'Nessrin A Taha, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Jordan University of Science and Technology'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Baseline demographic data and follow-up results may be shared after manuscript acceptance by international journals'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jordan University of Science and Technology', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}