Clinical trial

Clinical and Radiographic Evaluation of Indirect Pulp Capping Using Biodentine and Theracal Light-cured in Primary Molars

Name
R-PED-6-21-6
Description
this study is aimed to conduct tomographic evaluation of reparative dentin bridges formed after indirect pulp capping with Biodentine and Theracal light cured. The null hypothesis of the study is that there will be no difference in the quantity and quality of reparative dentin formation between the tested materials used for the indirect pulp capping
Trial arms
Trial start
2023-01-30
Estimated PCD
2023-10-01
Trial end
2023-10-01
Status
Completed
Phase
Early phase I
Treatment
Biodentine
17 primary second molars of 17 children will be capped with Biodentine
Arms:
Biodentine
Theracal light cured
17 primary second molars of 17 children will be capped with Theracal light cured
Arms:
Theracal light cured
Size
17
Primary endpoint
Thickness of dentin in mm
UP to 9 months postoperatively
Radiodenisty in Hounsfield units
UP to 9 months postoperatively
pulp vitality
UP to 9 months postoperatively
Eligibility criteria
Inclusion Criteria: 1. Each child has bilateral vital cavitated carious lesions in primary molars. 2. Positive vital pulp testing for both hot and cold response; is determined by ethyl chloride in cold pulp testing and heated gutta percha in hot pulp testing. Pain caused by these tests should not persist after the stimulus is removed. 3. Patient and parent cooperation. 4. Accessible isolation for the operated tooth with rubber dam. 5. primary molars with cavitated carious lesion on either occlusal or proximal surface that extend into the dentin . 6. Availability of remaining dentin thickness over the pulp. 7. Normal lamina dura and periodontal ligaments. 8 Absence of external and internal root resorption. Exclusion Criteria: 1. Spontaneous pain, or persistent swelling or fistula. 2. Pain with percussion, presence of abscess and pathological mobility. 3. Uncooperative patient. 4. Progression of caries lesion to pulp and pulp exposure. 5. Presence of periapical lesion as abscess, cyst or granuloma. 6. Unhealthy bony tissues.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 17, 'type': 'ACTUAL'}}
Updated at
2024-05-01

1 organization

2 products

3 indications

Organization
Tanta University
Product
Biodentine
Indication
Pulp Capping
Indication
Biodentine
Indication
Theracal
Product
Theracal