Ignite Creation Date:
2025-12-24 @ 6:25 PM
Ignite Modification Date:
2026-01-04 @ 10:29 AM
Study NCT ID:
NCT05425368
Status:
UNKNOWN
Last Update Posted:
2022-06-21
First Post:
2022-06-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparing Two Indirect Pulp Capping Agents for Permanent Teeth
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C024633', 'term': 'silver diamine fluoride'}, {'id': 'C086631', 'term': 'mineral trioxide aggregate'}, {'id': 'D000068437', 'term': 'Pemetrexed'}], 'ancestors': [{'id': 'D006147', 'term': 'Guanine'}, {'id': 'D007042', 'term': 'Hypoxanthines'}, {'id': 'D011688', 'term': 'Purinones'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D005971', 'term': 'Glutamates'}, {'id': 'D024342', 'term': 'Amino Acids, Acidic'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D000600', 'term': 'Amino Acids, Dicarboxylic'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Two blinded (patient, radiographic assessor of results)'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-08-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2023-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-06-15', 'studyFirstSubmitDate': '2022-06-14', 'studyFirstSubmitQcDate': '2022-06-15', 'lastUpdatePostDateStruct': {'date': '2022-06-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dentin bridge formation', 'timeFrame': '6 months', 'description': 'Dentin bridge formation will be measured in millimeters on standardized digital radiographs taken by Digital Radiographic examination'}], 'secondaryOutcomes': [{'measure': 'Postoperative pain', 'timeFrame': '1 week', 'description': 'Postoperative pain will be assessed by questioning the patient or the guardian whether there is postoperative pain or not, Binary (yes or no)'}, {'measure': 'Absence of sinus or fistula', 'timeFrame': '3 months', 'description': 'Intraoral Visual examination will be carried out to assess if there is a sinus or fistula, Binary (present/absent)'}, {'measure': 'Absence of sinus or fistula', 'timeFrame': '6 months', 'description': 'Intraoral Visual examination will be carried out to assess if there is a sinus or fistula, Binary (present/absent)'}, {'measure': 'radiographic success', 'timeFrame': '6 months', 'description': 'Absence of any adverse radiographic findings (Periodontal membrane space widening, bone resorption, pulp stones will be assessed if present or absent by digital radiographic examination, Binary (present or absent)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['partial caries removal', 'indirect pulp capping', 'fluorides'], 'conditions': ['Deep Caries']}, 'descriptionModule': {'briefSummary': 'Aim of the study:\n\nTo evaluate clinical and radiographic success rates of silver diamine fluoride versus mineral trioxide aggregate as indirect pulp capping agents in deeply carious young first permanent molars.', 'detailedDescription': 'Indirect pulp treatment has become a common maneuver in vital pulp therapy in recent years and is a procedure performed in teeth with deep carious lesions approximating the pulp but without any signs or symptoms of irreversible pulpal changes.\n\nSilver Diamine Fluoride is used to arrest caries lesions in primary teeth but according to the AAPD,2021 more research is needed on the use of SDF to arrest caries lesions in permanent teeth.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '14 Years', 'minimumAge': '9 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient and parent showing cooperation and compliance.\n* Children 9-14 years old\n* Vital deeply carious young first permanent molar(s) with complete root formation\n* Asymptomatic teeth or without clinical symptoms of spontaneous pain\n* Both genders will be included.\n\nExclusion Criteria:\n\n* Children unable to return for recall visits.\n* Any clinical signs of irreversible pulpitis or pulp necrosis (spontaneous pain, pain on percussion, abscess, sinus).\n* Any radiographic sign of irreversible pulp pathologies or pulp necrosis (periapical radiolucency, internal or external root resorption)'}, 'identificationModule': {'nctId': 'NCT05425368', 'briefTitle': 'Comparing Two Indirect Pulp Capping Agents for Permanent Teeth', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Clinical and Radiographic Evaluation of Silver Diamine Fluoride Versus Mineral Trioxide Aggregate as Indirect Pulp Capping Agents in Deeply Carious Young Permanent Molars Randomized Controlled Clinical Trial', 'orgStudyIdInfo': {'id': 'Indirect pulp capping'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'silver diamine fluoride group', 'description': 'partial caries removal will be carried out then Silver Diamine Fluoride will be applied as indirect pulp capping agent and rubbed for 1 minute followed by Glass ionomer filling', 'interventionNames': ['Drug: Silver diamine fluoride']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'mineral trioxide aggregate group', 'description': 'partial caries removal will be carried out then mineral trioxide aggregate will be placed as indirect pulp capping agent followed by glass ionomer filling', 'interventionNames': ['Drug: Mineral trioxide aggregate']}], 'interventions': [{'name': 'Silver diamine fluoride', 'type': 'DRUG', 'otherNames': ['SDF'], 'description': 'First permanent molars in this group will receive 38% silver diamine fluoride as an indirect pulp capping material.', 'armGroupLabels': ['silver diamine fluoride group']}, {'name': 'Mineral trioxide aggregate', 'type': 'DRUG', 'otherNames': ['MTA'], 'description': 'First permanent molars in this group will receive mineral trioxide aggregate as an indirect pulp capping material.', 'armGroupLabels': ['mineral trioxide aggregate group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Marwa Ahmed Ahmed Zaghloul', 'role': 'CONTACT', 'email': 'marwa_zaghloul@dentistry.cu.edu.eg', 'phone': '+201002798304'}, {'name': 'Randa Youssef Abd Al Gawad', 'role': 'CONTACT', 'email': 'randa.youssef@dentistry.cu.edu.eg'}], 'overallOfficials': [{'name': 'Manal Ahmed El Sayed', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Professor of Pediatric Dentistry and Dental Public Health, Faculty of Dentistry, Cairo University'}, {'name': 'Randa Youssef Abd Al Gawad', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Professor of Pediatric Dentistry and Dental Public Health, Faculty of Dentistry, Cairo University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Marwa Ahmed Ahmed Zaghloul', 'investigatorAffiliation': 'Cairo University'}}}}