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Clinical trial

Radiographic and Clinical Evaluation of Indirect and Direct Pulp Capping in Primary Molars Using TheraCal (LC)

ID
Name
FDASU-RECIM041919
Description
A randomized clinical trial that aims to evaluate clinical and radiographic success rates of indirect pulp capping and direct pulp capping in primary molars with reversible pulpitis using a light-cured tri-calcium silicate base material (TheraCal (LC)).
Trial arms
Trial start
2019-09-01
Estimated PCD
2021-11-30
Trial end
2021-12-15
Status
Completed
Phase
Early phase I
Treatment
Light cured tri-calcium silicate base material
TheraCal (LC) (BISCO Inc., Schamburg, IL, USA) was introduced in (2011), are available commercially as flowable cement applicable via syringe
Arms:
Direct Pulp Capping, Indirect Pulp Capping
Other names:
TheraCal (LC)
Size
40
Primary endpoint
recording signs and symptoms through clinical examination
one year follow-up
Eligibility criteria
Inclusion Criteria: 1. Age: 4-7 years. 2. Free medical history. 3. Complete physical and mental health. 4. Patient cooperation 5. restorable mandibular primary molars Exclusion Criteria: 1. Clinical symptoms or irreversible pulpitis as (spontaneous pain, throbbing pain) 2. Soft tissue swelling, draining fistula or sinus tracts. 3. Tenderness to percussion. 4. Pathological Tooth mobility. 5. Widening of periodontal membrane space
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Simple parallel randomization was performed by using computerized random numbers', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'maskingDescription': 'The participants and the outcome assessor were blinded. The primary investigator blinding was impossible', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 40, 'type': 'ACTUAL'}}
Updated at
2023-02-03

1 organization

1 product

4 indications

Organization
Ain Shams University
Product
Light cured tri-calcium silicate
Indication
Dental Caries
Indication
Indirect Pulp Capping
Indication
Direct Pulp Capping
Indication
Pulpitis