Pulp Capping in Primary Molars Using TheraCal (LC)

Study Overview
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Brief Summary
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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)).

Detailed Description
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Participating primary molars will be randomly allocated to one of the following groups: Indirect pulp capping group or Direct pulp capping group. A light-cured tri-calcium silicate base material (TheraCal (LC) ) will be used in the two groups as a dressing material. Patients will be recruited from the outpatient clinic of the pediatric dentistry department, Faculty of Dentistry Ain Shams University. The participant will be recalled for follow-up assessments at 3, 6,9, and 12 months.

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

Conditions
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Deep Caries, Indirect Pulp Capping, Direct Pulp Capping, Reversible Pulpitis, Decayed Teeth, Vital Pulp Therapy

Intervention / Treatment
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* Drug: Light cured tri-calcium silicate base material


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age: 4-7 years. Free medical history. Complete physical and mental health. Patient cooperation restorable mandibular primary molars Exclusion Criteria: Clinical symptoms or irreversible pulpitis as (spontaneous pain, throbbing pain) Soft tissue swelling, draining fistula or sinus tracts. Tenderness to percussion. Pathological Tooth mobility. Widening of periodontal membrane space

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 7 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Simple parallel randomization was performed by using computerized random numbers
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Indirect Pulp Capping<br>TheraCal (LC) will be applied to affected dentin after excavation of infected dentin | Drug: Light cured tri-calcium silicate base material<br>* TheraCal (LC) (BISCO Inc., Schamburg, IL, USA) was introduced in (2011), are available commercially as flowable cement applicable via syringe<br>* Other names: TheraCal (LC);|
| Experimental: Direct Pulp Capping<br>TheraCal (LC) will be applied to pinpoint pulp exposures (less than 1mm ) in vital pulps surrounded by sound dentin. | Drug: Light cured tri-calcium silicate base material<br>* TheraCal (LC) (BISCO Inc., Schamburg, IL, USA) was introduced in (2011), are available commercially as flowable cement applicable via syringe<br>* Other names: TheraCal (LC);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| recording signs and symptoms through clinical examination | All the primary molars participating in this study will be examined clinically under the illumination of dental unit, percussion and palpation test will be performed to ensure absence of any sign and symptoms of irreversible pulpitis or nectrotic pulp during follow -up period. | one year follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| recording pathological Changes in Radiographic examination | All the primary molars participating in this study will be examined radiographically every (3,6,9,12 months) to ensure the absence of any pathological changes . | one year follow-up | 
| Evaluation of TheraCal (LC) as a pulp capping material | Clinical and radiographic examination will be done to each tooth participating in this study to evaluate the efficiency of TheraCal (LC) when used as a pulp capping material in primary molars . | one year follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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IPC , DPC