Conservative Pulp Therapy of Primary Molars Using TheraCAL

Study Overview
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Brief Summary
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The study is a clinical trial that assesses the clinical and radiographic success rates of 3 conservative pulp therapy treatments in primary molars compared to conventional pulpotomy using a bioactive dual cured calcium silicate cement (TheraCAL PT).

Detailed Description
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Participating Children will be recruited from the outpatient's clinic of pediatric dentistry department , Faculty of Dentistry Ain Shams University and will be allocated to one of the following groups; Indirect pulp capping, direct pulp capping, partial pulpotomy or pulpotomy. TheraCAL PT, a dual cured tricalcium silicate cement will be used in all groups as the pulp capping material. Children will be followed every 6 months for a period of 1 year to evaluate clinical and radiographic success.

Official Title
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Indirect Pulp Capping, Direct Pulp Capping, Partial Pulpotomy, Pulpotomy of Primary Molars Using TheraCal; A Clinical Trial

Conditions
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Reversible Pulpitis

Intervention / Treatment
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* Drug: Dual cured resin modified tricalcium silicate cement


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Four to six years old healthy children Cooperative (frankle scale + and ++) With at least one vital and restorable primary molar with deep caries. Exclusion Criteria: History of spontaneous pain, swelling, or sinus tract Pathological mobility pain on percussion Furcation or periapical radiolucency Internal or external pathological root resorption Widening of periodontal membrane space Discontinuity of lamina dura.

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 6 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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: indirect pulp capping<br>TheraCAL PT will be applied to affected dentin covering the pup. | Drug: Dual cured resin modified tricalcium silicate cement<br>* A resin based, dual cured tricalcium silicate based cement<br>* Other names: TheraCal PT;|
| Experimental: Direct pulp Capping<br>TheraCAL PT will be applied to pinpoint pulp exposures surrounded by sound dentin. | Drug: Dual cured resin modified tricalcium silicate cement<br>* A resin based, dual cured tricalcium silicate based cement<br>* Other names: TheraCal PT;|
| Experimental: Partial Pulpotomy<br>Pulp exposure will be enlarged to a depth of 1-3 mm by a sterile round diamond bur, and then TheraCAL PT will applied after hemostasis. | Drug: Dual cured resin modified tricalcium silicate cement<br>* A resin based, dual cured tricalcium silicate based cement<br>* Other names: TheraCal PT;|
| Experimental: pulpotomy<br>complete removal of coronal pulp tissue will be attempted if bleeding persisted after attempting Partial pulpotomy for exposures that are not eligible for DPC. TheraCAL PT will be applied thereafter, after achieving hemostasis. | Drug: Dual cured resin modified tricalcium silicate cement<br>* A resin based, dual cured tricalcium silicate based cement<br>* Other names: TheraCal PT;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Visual and tactile clinical examination | Teeth will examined for any clinical signs of irreversible pulpitis or pulp necrosis | every 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Dental Periapical Radiographic examination | Teeth will be examined for any radiographic signs of pulp necrosis | every 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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indirect pulp capping, direct pulp capping, partial pulpotomy, pulpotomy, TheraCal, primary molars