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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Resin Modified Calcium Silicate | Experimental | light-cured resin-modified calcium silicate-filled base/ liner material designed for direct and indirect pulp capping |
|
| Light Cured Calcium Hydroxide | Active Comparator | gold standard for pulp capping, It allows for the formation of a reparative dentine bridge through cellular differentiation, extracellular matrix secretion and subsequent mineralization. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Calcium silicate liner | Drug | new light-cured resin-modified calcium silicate-filled base/ liner material designed for direct and indirect pulp capping |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Calcium hydroxide liner | Drug | Calcium hydroxide is the gold standard for pulp capping, allows for the formation of a reparative dentin bridge |
|
| 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 |