Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2025-12-26 @ 12:40 AM
Study NCT ID:
NCT04710160
Status:
UNKNOWN
Last Update Posted:
2021-08-05
First Post:
2021-01-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical and Radiographic Evaluation in Pulpotomy of Primary Molars Using Protooth Vs. MTA
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C086631', 'term': 'mineral trioxide aggregate'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-08', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2022-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-08-04', 'studyFirstSubmitDate': '2021-01-12', 'studyFirstSubmitQcDate': '2021-01-13', 'lastUpdatePostDateStruct': {'date': '2021-08-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-01-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10-22', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical evaluation including postoperative pain , pain on percussion or palpation will be measured using VAS', 'timeFrame': '12 months', 'description': 'Post-operative pain following pulpotomy treatment will be measured.\n\nA pain chart using visual analogue scale (VAS) will be used to record the patients\' pain levels. The VAS (0-10 scale) consists of a line anchored by two extremes "No pain" and "the worst pain". Patients will be asked to choose the mark that represented their level of pain from 0 to 10. Pain level will be assigned as follow:\n\n0, "no pain" 1-3, "mild pain" 4-6, "moderate pain" 7-10, "severe pain" Using the VAS chart, the patient will choose and record the most appropriate pain rating according to the pain intensity endured.'}], 'secondaryOutcomes': [{'measure': 'Radiographic evaluation following the Pulpotomy treatment will be measured', 'timeFrame': '12 months', 'description': 'Binary assessment of the radiographs taken after the treatment ( if there is any radiolucent or widening in the lamina sure nor evidence of internal/external pathologic root resorption)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pulpotomy , Primary molars , Protooth , MTA'], 'conditions': ['Clinical Evaluation Including Pain and Swelling']}, 'descriptionModule': {'briefSummary': 'The aim of the study is to evaluate the clinical and radiographic success in pulpotomy using novel fast-setting calcium silicate cement (Protooth) versus MTA in exposed primary molars.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '8 Years', 'minimumAge': '4 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Complete physical and mental health, with no confounding history of systemic disease and/or use of special local or systemic drugs\n* No allergic reactions recorded in patient history\n* Having primary molar teeth in one jaw, having deep caries and vital pulp.\n* No history of spontaneous pain, pathologic mobility, draining sinus tract, redness or swelling of vestibule\n* Normal gingival and periodontal condition, with no sensitivity to vestibular palpation, and no pain on percussion test\n\n * Radiographic criteria:\n* No sign of radiolucency in periapical or furcation area\n* No widening of PDL space or loss of lamina dura continuity\n* No evidence of internal/external pathologic root resorption\n\nExclusion Criteria:\n\n* Lack of informed consent by the child patient's parent\n* Lack of informed consent by the child patient's parent\n* Unable to attend follow-up visits.\n* Refusal of participation."}, 'identificationModule': {'nctId': 'NCT04710160', 'briefTitle': 'Clinical and Radiographic Evaluation in Pulpotomy of Primary Molars Using Protooth Vs. MTA', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Clinical and Radiographic Evaluation in Pulpotomy of Primary Molars Using Novel Fast-setting Calcium Silicate Cement (Protooth) Versus Mineral Trioxide Aggregate (MTA): A Pilot Study', 'orgStudyIdInfo': {'id': 'Pedo193'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Novel fast setting calcium silicate ( Protooth)', 'description': 'In the form of powder and liquid to be mixed together to form paste.', 'interventionNames': ['Drug: Novel fast-setting calcium silicate cement (Protooth)']}, {'type': 'EXPERIMENTAL', 'label': 'MTA', 'description': 'In form of powder to be mixed with saline to form paste.', 'interventionNames': ['Drug: Novel fast-setting calcium silicate cement (Protooth)']}], 'interventions': [{'name': 'Novel fast-setting calcium silicate cement (Protooth)', 'type': 'DRUG', 'otherNames': ['mineral trioxide aggregate (MTA )'], 'description': 'In form of power and liquid to be mixed together to form a paste.', 'armGroupLabels': ['MTA', 'Novel fast setting calcium silicate ( Protooth)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11553', 'city': 'Cairo', 'state': 'El Manial', 'country': 'Egypt', 'contacts': [{'name': 'Adel Elbardissy, Professor', 'role': 'CONTACT', 'email': 'adelbardissy@dentistry.cu.edu.eg', 'phone': '01271289999'}, {'name': 'Passant Nagy, Doctorat', 'role': 'CONTACT', 'email': 'passant.nagi@dentistry.cu.edu.eg', 'phone': '01280557107'}], 'facility': 'Faculty of Dentsitry , Cairo University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'Adel Elbardissy, professor', 'role': 'CONTACT', 'email': 'adelbardissy@dentistry.cu.edu.eg', 'phone': '01271289999'}, {'name': 'Passant Nagy, Doctorat', 'role': 'CONTACT', 'email': 'passant.nagi@dentistry.cu.edu.eg', 'phone': '0128557107'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'principle investigator', 'investigatorFullName': 'Nashwa Ossama Ahmed Elshaer', 'investigatorAffiliation': 'Cairo University'}}}}