Ignite Creation Date:
2025-12-24 @ 1:20 PM
Ignite Modification Date:
2026-02-12 @ 3:44 AM
Study NCT ID:
NCT04902495
Status:
RECRUITING
Last Update Posted:
2024-04-05
First Post:
2020-06-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical and Radiographic Evaluation of Pulpotomies in Primary Molars Using Tricalcium Silicate Cements
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C506393', 'term': 'tricalcium silicate'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 61}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-01-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2024-12-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-04', 'studyFirstSubmitDate': '2020-06-30', 'studyFirstSubmitQcDate': '2021-05-20', 'lastUpdatePostDateStruct': {'date': '2024-04-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-05-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-11-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'visual examination', 'timeFrame': '12 months', 'description': 'Clinical examination.Data will be recorded in terms of clinical signs of success.Clinical failure was determined by the subjective symptoms as explained by the participants and objective signs as recorded during clinical examination.'}, {'measure': 'Radiographic Success', 'timeFrame': '12 months', 'description': 'RX examination,Radiographic evaluation if success was performed according evidence of perirradicular or furcation pathosis or pathology root resorption.'}], 'secondaryOutcomes': [{'measure': 'Radicular Radiolucency', 'timeFrame': '12 months', 'description': 'RX examination,Radiographic evaluation if success was performed according evidence of perirradicular or furcation pathosis.'}, {'measure': 'Internal Resorption', 'timeFrame': '12 months', 'description': 'RX examination,Radiographic evaluation if success was performed according evidence of pathology root resorption.'}, {'measure': 'External Resorption', 'timeFrame': '12 months', 'description': 'RX examination,Radiographic evaluation if success was performed according evidence of pathology root resorption.'}, {'measure': 'Furcation Radiolucency', 'timeFrame': '12 months', 'description': 'RX examination,Radiographic evaluation if success was performed according evidence of perirradicular or furcation pathosis.'}, {'measure': 'Symptoms of pain', 'timeFrame': '12 months', 'description': 'Clinical examination,The patient will be recalled for control . Data will be recorded in terms of presence of symptoms, clinical and radiographic signs of success / failure, vertical and lateral percussion, periodontal probing and periapical and bitewing be implemented following the same methodology as in the initial evaluation.Clinical failure was determined by the subjective symptoms as explained by the participants.'}, {'measure': 'Swelling', 'timeFrame': '12 months', 'description': 'Clinical examination . Clinical failure was determined by the subjective symptoms as explained by the participants and objective signs as recorded during clinical examination including swelling.'}, {'measure': 'Fistulation', 'timeFrame': '12 months', 'description': 'Clinical and RX examination,The patient will be recalled for control .Clinical failure was determined by the subjective symptoms as explained by the participants and objective signs as recorded during clinical examination including abscess.'}, {'measure': 'Pathological Mobility', 'timeFrame': '12 months', 'description': 'Clinical examination,The patient will be recalled for control.Clinical failure was determined by the subjective symptoms as explained by the participants and objective signs as recorded during clinical examination including mobility.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Primary Molar Pulpotomy']}, 'descriptionModule': {'briefSummary': 'The objective of the study is to evaluate the success rate of pulpotomies in temporary molars using different types of hemostats and pulp coating materials based on tricalcium silicates, in patients who have attended the Dental Clinic of the International University of Catalonia (UIC).', 'detailedDescription': 'This prospective randomized clinical trial study has been approved by the\n\nScientific Committee in January of 2017 and by Ethics Committee (END-ECL- 2017-01) . It will be conducted in patients needing a vital pulp\n\ntherapy treatment at the Pediatric Dentistry Department of Universitat Internacional de Catalunya (Sant Cugat del Vallés, Barcelona, Spain). The necessary statistical sample size assuming an alpha risk of 0.05, a beta risk of 0.05 and a power of 95% sample, the required sample obtained by group resulted in 52. Given an estimate upwards of 20% of drop-outs in controls, the final size results in 62.4 (63 cases per group).\n\nThe data collection will be recollected using Excel program. Statgraphics Centurion XV software (StatPoint Technologies, Inc., Warrenton, VA, USA) will be used for statistical analysis. The chi-square test will be used and logistic regression analysis of the results will be performed to assess differences between groups with a significance level of P \\<0.05.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '9 Years', 'minimumAge': '4 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Responsible patients or parents or guardians who demonstrate that they understand the study and are willing to participate, as evidenced by signing the voluntary informed consent and receiving a signed and dated copy of the informed consent form.\n* Children under 18 years of age with informed parental consent, correctly understood.\n* Patient understands and is willing to comply with all study procedures and restrictions.\n* Absence of clinical and radiographic evidence of pulp degeneration such as excessive bleeding, internal and / or external root resorption, destruction of the furcation.\n* Asymptomatic and vital primary molars whose pulp exposure occurred during caries removal.\n\nExclusion Criteria:\n\n* Patients with systemic pathologies (diabetes, inmunosuppresed or any clinically significant or relevant oral abnormality).\n* Previous history of allergic reaction to local anesthesics or to the different constituents of the pulp agents to be studied.\n* Pulp diagnosis of irreversible pulpits or pulp necrosis, root resorption, root fractures, pathological mobility, spontaneous pain, impossibility of restoration, and if pulpotomy is not the treatment of choice.'}, 'identificationModule': {'nctId': 'NCT04902495', 'briefTitle': 'Clinical and Radiographic Evaluation of Pulpotomies in Primary Molars Using Tricalcium Silicate Cements', 'organization': {'class': 'OTHER', 'fullName': 'Universitat Internacional de Catalunya'}, 'officialTitle': 'Clinical and Radiographic Evaluation of Pulpotomies in Primary Molars Using Tricalcium Silicate Cements.', 'orgStudyIdInfo': {'id': 'UIC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pulp Dressing MTA Angelus', 'description': 'pulp therapy', 'interventionNames': ['Other: MTA HP Repair']}, {'type': 'EXPERIMENTAL', 'label': 'Pulp Dressing MTA Pro Root', 'description': 'pulp therapy', 'interventionNames': ['Other: MTA Pro Root']}, {'type': 'EXPERIMENTAL', 'label': 'Pulp Dressing Biodentine', 'description': 'pulp therapy', 'interventionNames': ['Other: Biodentine']}], 'interventions': [{'name': 'MTA Pro Root', 'type': 'OTHER', 'description': 'pulp therapy', 'armGroupLabels': ['Pulp Dressing MTA Pro Root']}, {'name': 'MTA HP Repair', 'type': 'OTHER', 'description': 'pulp therapy', 'armGroupLabels': ['Pulp Dressing MTA Angelus']}, {'name': 'Biodentine', 'type': 'OTHER', 'description': 'pulp therapy', 'armGroupLabels': ['Pulp Dressing Biodentine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08195', 'city': 'Sant Cugat del Vallès', 'state': 'Barcelona', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Francisco Guinot Jimeno, DDS, MsC', 'role': 'CONTACT', 'email': 'fguinot79@hotmail.com', 'phone': '0034 93 5045000'}, {'name': 'Francisco Guinot Jimeno, DDS, MsC', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'ANA VELOSO DURAN, DDS, MsC', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Universitat Internacional de Catalunya', 'geoPoint': {'lat': 41.47063, 'lon': 2.08611}}], 'centralContacts': [{'name': 'Francisco Guinot Jimeno, DDS, MsC', 'role': 'CONTACT', 'email': 'fguinot79@hotmail.com', 'phone': '0034 93 504 50 00'}, {'name': 'ANA VELOSO DURAN, DDS, MsC', 'role': 'CONTACT', 'email': 'ana_veloso13@hotmail.com', 'phone': '0034 93 504 50 00'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitat Internacional de Catalunya', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of the pediatric dentistry department.', 'investigatorFullName': 'Francisco Guinot-Jimeno', 'investigatorAffiliation': 'Universitat Internacional de Catalunya'}}}}