Indirect Pulp Capping Using Biodentine and Theracal Light-cured in Primary Molars

Study Overview
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Brief Summary
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this study is aimed to conduct tomographic evaluation of reparative dentin bridges formed after indirect pulp capping with Biodentine and Theracal light cured. The null hypothesis of the study is that there will be no difference in the quantity and quality of reparative dentin formation between the tested materials used for the indirect pulp capping

Detailed Description
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Many materials have been used in indirect pulp capping for primary dentition. An ideal pulp capping material is to be successful when it is biocompatible, radiopaque, maintain good seal, protect the pulp against bacterial invasion in both long and short run, release sustained amounts of calcium ions, act as reservoir for calcium hydroxide and stimulate reparative dentin formation through inducing the pulp cells to form odontoblasts. Theracal light cured is a light-cured resin modified calcium silicate (RMCS) used as an indirect pulp capping material. It releases more calcium ions than Mineral trioxide aggregate or dycal inducing reparative dentin and dentin bridge formation.Theracal light cured showed better sealing ability and less microleakage than Mineral trioxide aggregate and Biodentine

Official Title
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Clinical and Radiographic Evaluation of Indirect Pulp Capping Using Biodentine and Theracal Light-cured in Primary Molars

Conditions
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Pulp Caping, Biodentine, Theracal

Intervention / Treatment
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* Drug: Biodentine
* Drug: Theracal light cured


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Each child has bilateral vital cavitated carious lesions in primary molars. Positive vital pulp testing for both hot and cold response; is determined by ethyl chloride in cold pulp testing and heated gutta percha in hot pulp testing. Pain caused by these tests should not persist after the stimulus is removed. Patient and parent cooperation. Accessible isolation for the operated tooth with rubber dam. primary molars with cavitated carious lesion on either occlusal or proximal surface that extend into the dentin . Availability of remaining dentin thickness over the pulp. Normal lamina dura and periodontal ligaments. 8 Absence of external and internal root resorption. Exclusion Criteria: Spontaneous pain, or persistent swelling or fistula. Pain with percussion, presence of abscess and pathological mobility. Uncooperative patient. Progression of caries lesion to pulp and pulp exposure. Presence of periapical lesion as abscess, cyst or granuloma. Unhealthy bony tissues.

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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No

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Biodentine<br>17 primary second molars of 17 children will be capped with Biodentine. | Drug: Biodentine<br>* 17 primary second molars of 17 children will be capped with Biodentine<br>|
| Active Comparator: Theracal light cured<br>17 primary second molars of 17 children will be capped with Theracal light cured | Drug: Theracal light cured<br>* 17 primary second molars of 17 children will be capped with Theracal light cured<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Thickness of dentin in mm | Cone-beam computed tomography(CBCT) scan will be used after placing the capping material once at the start immediately postoperative after restoration and at the end of follow up period after 9 months to evaluate the Thickness of dentin in mm | UP to 9 months postoperatively | 
| Radiodenisty in Hounsfield units | Cone-beam computed tomography(CBCT) scan will be used after placing the capping material once at the start immediately postoperative after restoration and at the end of follow up period after 9 months to evaluate the Radiodenisty in Hounsfield units | UP to 9 months postoperatively | 
| pulp vitality | The teeth in each group will be examined clinically after restoration and at the end of the follow up period using vitality tests. Treatment is considered to be successful when pulp remains vital with no signs of pain, no evidence of tooth mobility, normal tooth color, normal gingival health and presence of the restoration intact | UP to 9 months postoperatively |