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Clinical trial

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

ID
Name
14422022585603
Description
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.
Trial arms
Trial start
2023-09-01
Estimated PCD
2024-06-01
Trial end
2024-09-01
Status
Not yet recruiting
Phase
Early phase I
Treatment
Premixed Bio-ceramic MTA
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
Arms:
Premixed Bio-ceramic MTA
Other names:
Neoputty
Calcium hydroxide
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
Arms:
Calcium hydroxide
Other names:
Dycal, Hydcal
Size
40
Primary endpoint
Immediate Postoperative pain
one week
Eligibility criteria
Inclusion Criteria: * Patients who have young permanent molars with deep carious lesions. * Restorable young permanent molars with no clinical symptoms of irreversible pulpitis. * 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. Exclusion Criteria: * Medically compromised patients who have systemic disease. * Uncooperative patients who refuse treatment * Permanent molars that were previously restored * Children whose parents or caregivers refuse to participate in the study.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized controlled trial', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 40, 'type': 'ESTIMATED'}}
Updated at
2023-08-01

1 organization

2 products

1 indication

Organization
Cairo University
Product
Bio-ceramic MTA
Indication
Indirect Pulp Capping
Product
Calcium hydroxide