Light Cured Resin Modified Calcium Silicate Versus Light Cured Calcium Hydroxide in Indirect Pulp Treatment of Primary Molars

Study Overview
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Brief Summary
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The objective of this study is to explore if light cured resin modified Calcium silicate could result in better clinical and radiographic success if compared to light cured Calcium hydroxide when used in indirect pulp capping treatment in primary molars.

Detailed Description
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To evaluate clinical and radiographic success of resin modified calcium silicate in comparison to light cured calcium hydroxide as indirect pulp capping materials in primary molars. P: Children aged (4-7 years) with deep carious lesions in lower primary second molars indicated for indirect pulp treatment. I: Indirect pulp treatment using light cured resin modified Calcium Silicate (TheraCal). C: Indirect pulp treatment using light cured Calcium Hydroxide. O: clinical and radiographic success.

Official Title
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Clinical and Radiographic Evaluation of Light Cured Resin Modified Calcium Silicate Versus Light Cured Calcium Hydroxide in Indirect Pulp Treatment of Primary Molars

Conditions
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Deep Carious Lesion, Indirect Pulp Treatment

Intervention / Treatment
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* Drug: Calcium silicate liner
* Drug: Calcium hydroxide liner


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Medically free children. Age range from 4-7 years. Presence of lower second primary molars with deep carious occlusal lesion. No history of spontaneous pain (reversible pulpitis). Clinically: Absence of swelling, sinus, fistula, pain on percussion and tooth mobility. Radiographically: Absence of radiolucent lesions at furcation or periapical region and absence of internal or external root resorption. Exclusion Criteria: Uncooperative children. Any unmet previous criterion.

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
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Resin Modified Calcium Silicate<br>light-cured resin-modified calcium silicate-filled base/ liner material designed for direct and indirect pulp capping | Drug: Calcium silicate liner<br>* new light-cured resin-modified calcium silicate-filled base/ liner material designed for direct and indirect pulp capping<br>|
| Active Comparator: Light Cured Calcium Hydroxide<br>gold standard for pulp capping, It allows for the formation of a reparative dentine bridge through cellular differentiation, extracellular matrix secretion and subsequent mineralization. | Drug: Calcium hydroxide liner<br>* Calcium hydroxide is the gold standard for pulp capping, allows for the formation of a reparative dentin bridge<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative pain | Pain questionnaire (binary yes/no) | 1 month | 
| Postoperative pain | Pain questionnaire (binary yes/no) | 3 months | 
| Postoperative pain | Pain questionnaire (binary yes/no) | 6 months | 
| Postoperative pain | Pain questionnaire (binary yes/no) | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Swelling | Visual examination by the operator (binary yes/no) | 1 month | 
| Swelling | Visual examination by the operator (binary yes/no) | 3 months | 
| Swelling | Visual examination by the operator (binary yes/no) | 6 months | 
| Swelling | Visual examination by the operator (binary yes/no) | 12 months | 
| Sinus or fistula | Visual examination by the operator (binary yes/no) | 1 month | 
| Sinus or fistula | Visual examination by the operator (binary yes/no) | 3 months | 
| Sinus or fistula | Visual examination by the operator (binary yes/no) | 6 months | 
| Sinus or fistula | Visual examination by the operator (binary yes/no) | 12 months | 
| Tooth mobility | back of the mirror to check mobility (binary yes/no) | 1 month | 
| Tooth mobility | back of the mirror to check mobility (binary yes/no) | 3 months | 
| Tooth mobility | back of the mirror to check mobility (binary yes/no) | 6 months | 
| Tooth mobility | back of the mirror to check mobility (binary yes/no) | 12 months | 
| pain on percussion | back of the mirror to check pain on percussion (binary yes/no) | 1 month | 
| pain on percussion | back of the mirror to check pain on percussion (binary yes/no) | 3 months | 
| pain on percussion | back of the mirror to check pain on percussion (binary yes/no) | 6 months | 
| pain on percussion | back of the mirror to check pain on percussion (binary yes/no) | 12 months | 
| Occurrence of radiolucent lesions at furcation or periapical region | (binary yes/no) | 1 months | 
| Occurrence of radiolucent lesions at furcation or periapical region | (binary yes/no) | 3 months | 
| Occurrence of radiolucent lesions at furcation or periapical region | (binary yes/no) | 6 months | 
| Occurrence of radiolucent lesions at furcation or periapical region | (binary yes/no) | 12 months | 
| widening in the periodontal membrane space | (binary yes/no) | 1 month | 
| widening in the periodontal membrane space | (binary yes/no) | 3 months | 
| widening in the periodontal membrane space | (binary yes/no) | 6 months | 
| widening in the periodontal membrane space | (binary yes/no) | 12 months | 
| presence of internal or external root resorption | (binary yes/no) | 1 month | 
| presence of internal or external root resorption | (binary yes/no) | 3 months | 
| presence of internal or external root resorption | (binary yes/no) | 6 months | 
| presence of internal or external root resorption | (binary yes/no) | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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resin modified calcium silicate, indirect pulp treatment, primary molars