Ignite Creation Date:
2025-12-25 @ 2:22 AM
Ignite Modification Date:
2025-12-26 @ 12:54 AM
Study NCT ID:
NCT03410134
Status:
UNKNOWN
Last Update Posted:
2021-03-15
First Post:
2017-12-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Assessment of Vital Pulp Therapy in Permanent Molars
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': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2023-08-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-03-12', 'studyFirstSubmitDate': '2017-12-03', 'studyFirstSubmitQcDate': '2018-01-24', 'lastUpdatePostDateStruct': {'date': '2021-03-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-01-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical evaluation of vital pulp therapy in permanent teeth with irreversible pulpitis', 'timeFrame': '3 years', 'description': 'Long-term success of vital pulp therapy in young permanent teeth with irreversible pulpitis. Evaluation criteria will be;\n\n1. spontaneous pain (absent/present);\n2. tenderness to percussion/palpation (absent/present);\n3. mobility (no mobility/ 1mm/ 2mm/ 3mm mobility)\n4. swelling (absent/present);\n5. fistula (absent/present)\n6. periapical/interradicular radiolucency (absent/present);\n7. widened periodontal ligament (absent/present);\n8. loss of lamina dura (absent/present);\n9. internal/external root resorption (absent/present).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Permanent teeth', 'Vital pulp therapy', 'MTA'], 'conditions': ['Dental Caries Extending to Pulp', 'Pulp Disease, Dental']}, 'referencesModule': {'references': [{'pmid': '22431145', 'type': 'BACKGROUND', 'citation': 'Asgary S, Eghbal MJ, Ghoddusi J, Yazdani S. One-year results of vital pulp therapy in permanent molars with irreversible pulpitis: an ongoing multicenter, randomized, non-inferiority clinical trial. Clin Oral Investig. 2013 Mar;17(2):431-9. doi: 10.1007/s00784-012-0712-6. Epub 2012 Mar 21.'}, {'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.'}, {'pmid': '26841969', 'type': 'BACKGROUND', 'citation': 'Qudeimat MA, Alyahya A, Hasan AA. Mineral trioxide aggregate pulpotomy for permanent molars with clinical signs indicative of irreversible pulpitis: a preliminary study. Int Endod J. 2017 Feb;50(2):126-134. doi: 10.1111/iej.12614. Epub 2016 Feb 22.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the long term clinical performance of vital pulp therapy of young permanent teeth with irreversible pulpitis', 'detailedDescription': 'Permanent molar teeth meeting the inclusion criteria will be included into the study. Following local anaesthesia and dental dam application, caries excavation will be performed; and after exposure, the pulp will be amputated to the level of the canal orifices (full pulpotomy) using a sterile high-speed round bur under water coolant. After haemostasis is achieved, Mineral trioxide aggregate (MTA) will be gently placed over the pulp to a thickness of 2-3 mm and the tooth will be restored using glass ionomer cement and composite resin. A postoperative periapical radiograph will be taken. Patients will be reviewed at 6., 12., 24. and 36. months for clinical and radiographical success. The data will be analysed statistically using chi square test.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '6 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients and parents of the patients who accept to participate and sign the informed consent\n* Patients who have at least one vital permanent molar teeth with irreversible pulpitis symptoms\n* Teeth which can be restorable after the treatment.\n* Teeth which has good periodontal health and in the absence of sinus tracts or swelling.\n\nExclusion Criteria:\n\n* Patients and parents of the patients who does not accept to participate and sign the informed consent\n* Teeth which have dentoalveolar or extraoral swelling\n* Teeth which have periodontal disease, mobility or alveolar bone loss\n* Teeth which are not restorable\n* Patients who are not cooperative with the treatment'}, 'identificationModule': {'nctId': 'NCT03410134', 'briefTitle': 'Assessment of Vital Pulp Therapy in Permanent Molars', 'organization': {'class': 'OTHER', 'fullName': 'Hacettepe University'}, 'officialTitle': 'Clinical Evaluation of Vital Pulp Therapy in Young Permanent Molars With Irreversible Pulpitis', 'orgStudyIdInfo': {'id': 'Irreversible pulpitis'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'NeoMTA', 'description': 'Vital pulp therapy with NeoMTA', 'interventionNames': ['Device: NeoMTA']}], 'interventions': [{'name': 'NeoMTA', 'type': 'DEVICE', 'description': 'NeoMTA™ Plus® root and pulp treatment material is a powder/gel system with no resin. The components are an extremely fine powder primarily tricalcium and dicalcium silicate plus a water-based gel.', 'armGroupLabels': ['NeoMTA']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06100', 'city': 'Ankara', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Zafer C Cehreli, DDS, PhD', 'role': 'CONTACT', 'email': 'zcehreli@gmail.com', 'phone': '+903123052289'}, {'name': 'Beste Ozgur, DDS, PhD', 'role': 'CONTACT', 'email': 'besteisbitiren@yahoo.com', 'phone': '+903123052280'}, {'name': 'Zafer C Cehreli, DDS, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Gizem Erbas Unverdi, DDS, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Beste Ozgur, DDS, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Atilla S Atac, DDS, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Hacettepe University', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'centralContacts': [{'name': 'Zafer C Cehreli, Prof', 'role': 'CONTACT', 'email': 'zcehreli@gmail.com', 'phone': '00905353197969'}, {'name': 'Gizem E Unverdi', 'role': 'CONTACT', 'email': 'erbasgizem@yahoo.com', 'phone': '00905052805736'}], 'overallOfficials': [{'name': 'Zafer C Cehreli, DDS,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hacettepe University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hacettepe University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Zafer Cavit Cehreli, DDS, PhD', 'investigatorAffiliation': 'Hacettepe University'}}}}