Ignite Creation Date:
2025-12-26 @ 12:17 PM
Ignite Modification Date:
2026-01-01 @ 12:16 AM
Study NCT ID:
NCT05937100
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-05-30
First Post:
2023-06-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
New Vital Pulpotomy Medications in Primary Molars
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C031025', 'term': 'formocresol'}, {'id': 'C506393', 'term': 'tricalcium silicate'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'the observer and the recipients will be blinded to the study group to avoid bias (double blind randomized controlled trial)'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 48}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2025-08-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-25', 'studyFirstSubmitDate': '2023-06-30', 'studyFirstSubmitQcDate': '2023-07-07', 'lastUpdatePostDateStruct': {'date': '2025-05-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-07-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'clinically successful pulpotomy', 'timeFrame': '18 months', 'description': '1. Pain symptom - free teeth on percussion as well as during mastication.\n2. Absence of pathological tooth mobility.\n3. Absence of swelling of pulpal origin.\n4. . Absence of sinus tract.'}, {'measure': 'radiographically successful pulpotomy', 'timeFrame': '18 months', 'description': '1. No internal or external root resorption.\n2. No periapical or furcation radiolucency.\n3. No widening of periodontal ligament space.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hyaluronic Acid - Biodentine - Pulpotomy'], 'conditions': ['Carious Exposure of Pulp']}, 'descriptionModule': {'briefSummary': 'Evaluate clinically and radiographically the effect of biodentine and hyaluronic acid (HA) versus formocresol (FC) as pulpotomy medications in primary molars.', 'detailedDescription': 'Split mouth randomized controlled clinical trial. This study will be conducted on 96 teeth from 48 children in age group 4-7 years and have bilateral lower primary molars indicated for vital pulpotomy procedure. for:\n\n1. Clinical evaluation of biodentine, hyaluronic acid and formocresol groups according to presence of failure criteria at different follow up periods.\n2. Radiographic evaluation of biodentine, hyaluronic acid and formocresol groups according to presence of failure criteria at different follow up periods.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '7 Years', 'minimumAge': '4 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* -Clinical criteria\n\n 1. Restorable mandibular primary molars with deep carious lesions.\n 2. Absence of gingival swelling or sinus tract.\n 3. Absence of spontaneous pain\n 4. Absence of pain on percussion. B-Radiographic Criteria: Absence of\n\n <!-- -->\n\n 1. Discontinuity of lamina dura\n 2. Internal root resorption.\n 3. External root resorption.\n 4. inter-radicular or periapical bone destruction (radiolucency)\n\nExclusion Criteria:\n\n1. Excessive bleeding during pulp amputation.\n2. Non vital/necrotic teeth.\n3. Any sort of medical history contraindicating the pulp treatment.\n4. Teeth approximate exfoliation\n5. Patient's guardians are not intending to be part of the study.\n6. Retreatment of previously pulpotomy treated molar -"}, 'identificationModule': {'nctId': 'NCT05937100', 'briefTitle': 'New Vital Pulpotomy Medications in Primary Molars', 'organization': {'class': 'OTHER', 'fullName': 'Mansoura University'}, 'officialTitle': 'Clinical and Radiographic Evaluation of Hyaluronic Acid and Biodentine as Vital Pulpotomy Medications in Primary Molars: Randomized Controlled Clinical Trial', 'orgStudyIdInfo': {'id': 'A0103023PP'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'control: Formocresol', 'description': 'Teeth will be treated by using squeezed sterile cotton pellet with 20% formcresol for 1 minute then removed and pulp stumps will be dressed with a layer of zinc oxide-eugenol (ZOE) paste.', 'interventionNames': ['Drug: Formocresol']}, {'type': 'EXPERIMENTAL', 'label': 'Group A : (Biodentine)', 'description': "The biodentine mix will be prepared according to the manufacturer's instructions and condensed lightly with a condenser on the pulp stumps, and allowed to set.", 'interventionNames': ['Drug: Biodentine']}, {'type': 'EXPERIMENTAL', 'label': 'Group B : (Hyaluronic acid gel)', 'description': 'Hyaluronic acid gel will be compressed against the amputated pulp for 5 minutes. Then the pulp stumps will be dressed with a layer of zinc oxide-eugenol (ZOE) paste.', 'interventionNames': ['Drug: Hyaluronic acid gel']}], 'interventions': [{'name': 'Formocresol', 'type': 'DRUG', 'description': 'Molars will be anesthetized by local anesthesia. The rubber dam will be used for isolation. Caries will be removed by large spoon excavator. When pulpal exposure occurs, deroofing of the pulp chamber will be achieved then pulpal tissue will be amputated using sharp excavator. Hemostasis will be obtained by applying pressure with saline moist cotton pellet. If bleeding has not stopped within 5 min, tooth will be excluded from the study.Teeth will be treated by using squeezed sterile cotton pellet with 20% formcresol for 1 minute', 'armGroupLabels': ['control: Formocresol']}, {'name': 'Biodentine', 'type': 'DRUG', 'description': "Molars will be anesthetized by local anesthesia. The rubber dam will be used for isolation. Caries will be removed by large spoon excavator. When pulpal exposure occurs, deroofing of the pulp chamber will be achieved then pulpal tissue will be amputated using sharp excavator. Hemostasis will be obtained by applying pressure with saline moist cotton pellet. If bleeding has not stopped within 5 min, tooth will be excluded from the study.The biodentine mix will be prepared according to the manufacturer's instructions and condensed lightly with a condenser on the pulp stumps", 'armGroupLabels': ['Group A : (Biodentine)']}, {'name': 'Hyaluronic acid gel', 'type': 'DRUG', 'description': 'Molars will be anesthetized by local anesthesia. The rubber dam will be used for isolation. Caries will be removed by large spoon excavator. When pulpal exposure occurs, deroofing of the pulp chamber will be achieved then pulpal tissue will be amputated using sharp excavator. Hemostasis will be obtained by applying pressure with saline moist cotton pellet. If bleeding has not stopped within 5 min, tooth will be excluded from the study.Hyaluronic acid gel will be compressed against the amputated pulp for 5 minutes.', 'armGroupLabels': ['Group B : (Hyaluronic acid gel)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35511', 'city': 'Al Mansurah', 'country': 'Egypt', 'facility': 'Dentistry', 'geoPoint': {'lat': 31.03637, 'lon': 31.38069}}], 'overallOfficials': [{'name': 'Weaam I El-tantawy', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'assistant lecturer ,Faculty of Dentistry, Mansoura University B.D.S (2016)'}, {'name': 'Nadia M Farrag', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Professor ,Faculty of Dentistry, Mansoura University'}, {'name': 'Hossam E Hammouda', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Lecturer, Faculty of Dentistry, Mansoura University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mansoura University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'assistant lecturer at pediatric department-Mansoura University', 'investigatorFullName': 'Weaam ibrahiem eltantawy', 'investigatorAffiliation': 'Mansoura University'}}}}