Ignite Creation Date:
2025-12-24 @ 9:06 PM
Ignite Modification Date:
2026-01-02 @ 6:24 AM
Study NCT ID:
NCT05829304
Status:
UNKNOWN
Last Update Posted:
2023-04-25
First Post:
2022-12-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Comparative Clinical and Radiographic Study Of Collagen Based Pulpotomy in Cariously Exposed Vital Primary Molars
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'the blinding is not possible (unfortunately) due to the nature of the trial. Trial participants, outcome assessors and statistician will be blinded.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Teeth that will be included in the current trial will be randomly assigned one of the experimental groups using closed white envelopes (simple randomization 1:1 ratio).'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 19}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-06', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2024-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-04-23', 'studyFirstSubmitDate': '2022-12-21', 'studyFirstSubmitQcDate': '2023-04-23', 'lastUpdatePostDateStruct': {'date': '2023-04-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'postoperative pain', 'timeFrame': '3 days', 'description': 'postoperative pain following the placement of restoration by questioning the patient. using numerical pain rating scale Zero means patient have no pain, while 10 represents the most intense pain possible.'}], 'secondaryOutcomes': [{'measure': 'Absence of internal root resorption', 'timeFrame': 'up to 24 week', 'description': 'binary outcome detected with periapical x-ray by parallel technique using XCP film holder'}, {'measure': 'absence of swelling', 'timeFrame': 'up to 24 week', 'description': 'binary outcome detected with periapical x-ray by parallel technique using XCP film holder'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dental Caries in Children']}, 'referencesModule': {'references': [{'pmid': '34393127', 'type': 'BACKGROUND', 'citation': 'Anandan V, Inbanathan J, Saket P, Krishnamoorthy V, Gandhi S, Chandrababu VK. Assessment of Clinical and Radiographic Success Rate of Formocresol-based Pulpotomy versus Collagen-based Pulpotomy: An In Vivo Study. J Contemp Dent Pract. 2021 Jun 1;22(6):680-685.'}]}, 'descriptionModule': {'briefSummary': 'To assess post operative pain and survival rate after collagen based pulpotomy versus MTA pulpotomy in children with vital primary molars.', 'detailedDescription': 'Pulpotomy of vital primary molars is indicated when caries removal results in pulp exposure. Treatment approaches consist of devitalization using formocresol, preservation using ferric sulfate and regeneration using mineral trioxide aggregate of the remaining pulp tissue have been utilized to date. The ideal pulpotomy medicament would be biocompatible and bactericidal, in addition, to promote the healing of the root pulp and be compatible with the physiological process of root resorption.\n\nCollagen, which is available for dental implication, is already sterilized and also reinforced with antibiotic particles to efficiently aid in regeneration and repair without any contaminations. The collagen particles can be sterilized by various methods like irradiation, dry heat, and ethylene oxide, among which irradiation is the most frequently used method as it does not affect the structural stability'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '6 Years', 'minimumAge': '4 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Primary molar tooth not more than one-third of root resorption.\n2. Children with bilateral deep dental caries approximating the pulp in primary molars assessed both clinically and radiographically.\n3. systemically healthy.\n4. cooperative patients who will comply to follow up visits.\n\nExclusion Criteria:\n\n1. Children with medical, physical, or mental conditions.\n2. Primary molars with any congenital deformities.\n3. Previously accessed teeth.\n4. At operative procedure haemorrhage control is unachievable after pulpotomy.'}, 'identificationModule': {'nctId': 'NCT05829304', 'briefTitle': 'A Comparative Clinical and Radiographic Study Of Collagen Based Pulpotomy in Cariously Exposed Vital Primary Molars', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'A Comparative Clinical and Radiographic Study Of Collagen Based Pulpotomy Versus MTA Pulpotomy in Cariously Exposed Vital Primary Molars', 'orgStudyIdInfo': {'id': '251293'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Collagen based pulpotomy', 'description': "Application of rubber dam for isolation, then a standardized pulpotomy procedure will be performed. Remove pulpal tissues to the orifice level. Haemostasis will be achieved by the application of a wet cotton pellet.\n\nGroup I collagen-based Pulpotomy:\n\n1. After complete haemostasis, collagen based pulpotomy will be applied according to the manufacturer's instructions and gently placed over the pulp stumps to a thickness of 2 mm then the rest of the pulp chamber will be filled with glass ionomer cement.\n2. Tooth will be restored with stainless steel crown.", 'interventionNames': ['Other: MTA based pulpotomy', 'Other: Collagen based pulpotomy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'MTA based pulpotomy', 'description': 'Application of rubber dam for isolation, then a standardized pulpotomy procedure will be performed. Remove pulpal tissues to the orifice level. Haemostasis will be achieved by the application of a wet cotton pellet.\n\nGroup II MTA pulpotomy:\n\n1. After complete hemostasis, MTA+ Cerkamed will be manipulated to obtain a putty mix. This mix will be placed over the radicular pulp. condensation of the mix with a moistened cotton pellet, followed by application of glass ionomer cement.\n2. Tooth will then be restored with stainless steel crown.', 'interventionNames': ['Other: MTA based pulpotomy', 'Other: Collagen based pulpotomy']}], 'interventions': [{'name': 'MTA based pulpotomy', 'type': 'OTHER', 'description': 'The principal investigator will carry out all treatment procedures, and the patients will be assigned. It will be as split mouth, both groups A\\&B will be at the same patient.', 'armGroupLabels': ['Collagen based pulpotomy', 'MTA based pulpotomy']}, {'name': 'Collagen based pulpotomy', 'type': 'OTHER', 'description': 'The principal investigator will carry out all treatment procedures, and the patients will be assigned. It will be as split mouth, both groups A\\&B will be at the same patient.', 'armGroupLabels': ['Collagen based pulpotomy', 'MTA based pulpotomy']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Sherouk Elsayed, bachelor', 'role': 'CONTACT', 'email': 'sherouk.elsayed@dentistry.cu.edu.eg', 'phone': '+201005544373'}, {'name': 'passant nagi, lecturer', 'role': 'CONTACT', 'email': 'passant.nagi@dentistry.cu.edu.eg', 'phone': '+201280557107'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'sherouk atef elsayed', 'class': 'OTHER'}, 'collaborators': [{'name': 'Cairo University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'A comparative Clinical and Radiographic Study Of Collagen based Pulpotomy Versus MTA Pulpotomy in Cariously Exposed Vital Primary Molars', 'investigatorFullName': 'sherouk atef elsayed', 'investigatorAffiliation': 'Cairo University'}}}}