A Phase 4 interventional study of Biodentine and Theracal light cured in Pulp Caping, Biodentine and Theracal, sponsored by Tanta University. Completed at 1 site in Egypt. Open to participants aged 4 Years to 7 Years. Per ClinicalTrials.gov, last updated 2024-05-01.
Sponsored by Tanta University · Phase 4, Interventional, and Treatment
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
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
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Exclusion Criteria:
17 primary second molars of 17 children will be capped with Biodentine.
Drug: Biodentine
17 primary second molars of 17 children will be capped with Theracal light cured
Drug: Theracal light cured
17 primary second molars of 17 children will be capped with Biodentine
17 primary second molars of 17 children will be capped with Theracal light cured
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
Time frame: 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
Time frame: 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
Time frame: UP to 9 months postoperatively
Plan to share: Yes — The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Supporting information: Study protocol
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This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
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Tanta University