Ignite Creation Date:
2025-12-25 @ 12:14 AM
Ignite Modification Date:
2025-12-25 @ 10:16 PM
Study NCT ID:
NCT05928858
Status:
UNKNOWN
Last Update Posted:
2023-08-01
First Post:
2023-06-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Clinical And Radiographic Evaluation Of Premixed Bio-ceramic MTA In Indirect Pulp Capping Of Young Permanent Molars
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D002126', 'term': 'Calcium Hydroxide'}, {'id': 'C025702', 'term': 'Dycal'}], 'ancestors': [{'id': 'D006878', 'term': 'Hydroxides'}, {'id': 'D000468', 'term': 'Alkalies'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017610', 'term': 'Calcium Compounds'}, {'id': 'D000838', 'term': 'Anions'}, {'id': 'D007477', 'term': 'Ions'}, {'id': 'D004573', 'term': 'Electrolytes'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized controlled trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-09', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2024-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-07-28', 'studyFirstSubmitDate': '2023-06-24', 'studyFirstSubmitQcDate': '2023-06-24', 'lastUpdatePostDateStruct': {'date': '2023-08-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-07-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Immediate Postoperative pain', 'timeFrame': 'one week', 'description': 'post operative pain by Verbal analogue scale.It is a 10 cm long horizontal line with points labeled from 0 to 10 where (0) indicates no pain, (1-3) mild pain, (4-6) moderate pain, and (7-10) severe pain.'}], 'secondaryOutcomes': [{'measure': 'The thickness of newly formed dentin', 'timeFrame': '3,6,9,12 month', 'description': 'The thickness of newly formed dentin will be assessed in Mm through Digora software'}, {'measure': 'Soft tissue pathology', 'timeFrame': '3,6,9,12 month', 'description': 'Swelling, sinus tract, fistula, mobility and pain on percussion will be assessed by clinical examination either present or not (binary)'}, {'measure': 'Radiographic changes', 'timeFrame': '3,6,9,12 month', 'description': 'Radiolucency at the periapical or furcation area and Internal or external root resorption will be assessed through a digital periapical intraoral radiograph either present or not ( Binary)'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['neoputty', 'premixed bioceramic MTA', 'young permanent teeth', 'calcium hydroxide'], 'conditions': ['Indirect Pulp Capping']}, 'descriptionModule': {'briefSummary': 'The present study aims to evaluate the clinical and radiographic success of premixed bio-ceramic MTA versus calcium hydroxide in indirect pulp capping of young permanent molars.', 'detailedDescription': "Researchers are still in search of an ideal material for pulp capping, and they evaluated numerous dental materials. For many decades, calcium hydroxide has been the 'gold standard' material for maintaining pulp vitality. Both clinically and histologically, it has been found to produce satisfactory results in indirect and direct pulp capping because it can stimulate the formation of tertiary dentine by the pulp and it has antimicrobial properties.\n\nDue to the drawbacks of calcium hydroxide, several materials have been developed, such as NeoPUTTY which is premixed bio-ceramic Mineral Trioxide Aggregate (MTA) that triggers hydroxyapatite. Its firm, non-tacky consistency, wash-out resistance, and bioactivity make it a pediatric dentists' preferred material for every pulp need. It also delivers ready-to-use material for immediate placement with zero waste, saving cost and chair time."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '6 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who have young permanent molars with deep carious lesions.\n* Restorable young permanent molars with no clinical symptoms of irreversible pulpitis.\n* Permanent molars with no clinical or radiographic signs of pulp necrosis including swelling, fistula, pain on percussion,pathologic tooth mobility, thickening of the periodontal ligament space, radiolucency at the periapical area.\n\nExclusion Criteria:\n\n* Medically compromised patients who have systemic disease.\n* Uncooperative patients who refuse treatment\n* Permanent molars that were previously restored\n* Children whose parents or caregivers refuse to participate in the study.'}, 'identificationModule': {'nctId': 'NCT05928858', 'briefTitle': 'Clinical And Radiographic Evaluation Of Premixed Bio-ceramic MTA In Indirect Pulp Capping Of Young Permanent Molars', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Clinical And Radiographic Evaluation Of Premixed Bio-ceramic Mineral Trioxide Aggregate Versus Calcium Hydroxide In Indirect Pulp Capping Of Young Permanent Molars: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '14422022585603'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Premixed Bio-ceramic MTA', 'description': 'Partial caries removal will be carried out then Premixed Bio-ceramic MTA will be applied as indirect pulp capping agent followed by Glass ionomer filling and composite restoration', 'interventionNames': ['Drug: Premixed Bio-ceramic MTA']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Calcium hydroxide', 'description': 'Partial caries removal will be carried out then calcium hydroxide will be applied as indirect pulp capping agent followed by Glass ionomer filling and composite restoration', 'interventionNames': ['Drug: Calcium hydroxide']}], 'interventions': [{'name': 'Premixed Bio-ceramic MTA', 'type': 'DRUG', 'otherNames': ['Neoputty'], 'description': 'Partial caries removal will be carried out then Premixed Bio-ceramic MTA will be applied as indirect pulp capping agent followed by Glass ionomer filling and composite restoration', 'armGroupLabels': ['Premixed Bio-ceramic MTA']}, {'name': 'Calcium hydroxide', 'type': 'DRUG', 'otherNames': ['Dycal, Hydcal'], 'description': 'Partial caries removal will be carried out then calcium hydroxide will be applied as indirect pulp capping agent followed by Glass ionomer filling and composite restoration', 'armGroupLabels': ['Calcium hydroxide']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Aya Ad Hamza, Phd', 'role': 'CONTACT', 'email': 'aya.adel@dentistry.cu.edu.eg', 'phone': '01062315566'}, {'name': 'Sara Ah Mahmoud, Professor', 'role': 'CONTACT'}], 'overallOfficials': [{'name': 'Aya Ad Hamza, Phd', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cairo University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'IPD can be shared with citation to the investigator but not personal data of the patients to protect confidentiality.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant lecturer', 'investigatorFullName': 'Aya Adel Abd El-Hafez Osman Hamza', 'investigatorAffiliation': 'Cairo University'}}}}