Clinical trial

Histological and Radiographic Evaluation of the Effects of Direct Pulp Capping Agent on Human Pulp Tissue

Name
2264
Description
This in- vivo study was conducted to evaluate the response of human pulp tissue following direct pulp capping using four different pulp capping agents in premolars scheduled for extraction in patients undergoing orthodontic treatment.
Trial arms
Trial start
2024-04-01
Estimated PCD
2024-06-01
Trial end
2024-07-01
Status
Recruiting
Phase
Early phase I
Treatment
Biodentine
DIRECT PULP CAPPINGWILL BE DONE USING BIODENTINE
Arms:
BIODENTINE
Mineral Tri-Oxide Aggregate
DIRECT PULP CAPPINGWILL BE DONE USING MTA
Arms:
MINERAL TRIOXIDE AGGREGATE
Other names:
MTA
THERACAL LC
DIRECT PULP CAPPINGWILL BE DONE USING THERACAL LC
Arms:
THERACAL LC
TRISTRONTIUM ALUMINATE
DIRECT PULP CAPPINGWILL BE DONE USING TRISTRONTIUM ALUMINATE
Arms:
TRISTRONTIUM ALUMINATE
Size
40
Primary endpoint
RADIOGRAPHIC EVALUATION OF FOUR DIRECT PULP CAPPING MATERIALS ON HUMAN PULP TISSUE
90 DAYS
HISTOLOGICAL EVALUATION OF FOUR DIRECT PULP CAPPING MATERIALS ON HUMAN PULP TISSUE
90 DAYS
Eligibility criteria
INCLUSION CRITERIA: * CARIES-free, undamaged mature maxillary and mandibular premolars that were planned for extraction for orthodontic reasons. * Teeth that show no reaction to percussion. * Teeth with no previous restorations. * Teeth that show vitality, when checked with an electric pulp tester. * Teeth that show no signs of caries or periapical pathology when examined * radiographically. * Fully erupted teeth, that allowed proper application of rubber dam. EXCLUSION CRITERIA: * caries are present * Teeth with signs and symptoms of irreversible pulpitis, such as nighttime severe pain * or spontaneous pain. * Teeth that show sensitivity to hot and/or cold. * Radiographic examination reveals any signs of caries, periapical pathology, * internal/external root resorption, furcal radiolucency/ inter-radicular bone destruction * and/or calcifications in the pulp chamber or canals. * Medically compromised patient. * Pregnant patient.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 40, 'type': 'ESTIMATED'}}
Updated at
2024-05-30

1 organization

4 products

1 indication

Product
Biodentine
Indication
Pulpitis