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Evaluation of Biodentine Versus Glass Ionomer Cement in Treatment of Very Deep Carious Lesions

Deep Caries Clinical Trial

Official title:
Clinical and Radiographical Evaluation of New Bioactive Dentine Substitute (Biodentine) Versus Glass Ionomer Cement in Treatment of Very Deep Carious Lesions -Randomized Clinical Trial

Clinical Trial Summary

The aim of this study is to compare the effect of new bioactive dentine substitute (Biodentine) versus glass ionomer cement in very deep carious lesions clinically and radiographically using digital radiography in the terms of postoperative pain and biocompatibility to the pulp.

Clinical Trial Description

Roles and responsibilities: - Omnia Magdy Moustafa (O.M.) Operator, data entry & corresponding author; Assistant lecturer , - Mohmed Riad Farid (M.R.) Main supervisor, data monitoring & auditing; Professor, Conservative Dentistry - Rasha Raffat (R.R.) Co-supervisor, data entry & auditing; Lecturer, Conservative Dentistry Department - Amir Hafez Ibrahim (A.H.), *Mohamed Refaat El-Bialy (M.E.) (A.H) Lecturer, Conservative Dentistry Department, Faculty of Oral & Dental Medicine Cairo University,(M.E.) Assistant lecturer , Conservative Dentistry Department, Faculty of Oral & Dental Medicine Cairo University outcome assessors and data collection. - Omar Shalaan (O.S.) Demonstrator, Conservative Dentistry Department, Faculty of Oral & Dental Medicine Cairo University, for baseline data collection, recruitment, sequence generation, allocation concealment, patient retention and taking participants consents. Interventions: - Pre-operative clinical assessment : 1. Thermal testing using Refrigerant spray 2. percussion test 3. Palpation and clinical examination 4. peri-apical radiographs using digital radiograph - Caries removal procedure: Local anesthesia will be given to the patient then complete isolation to the tooth using rubber dame the operator O.M. will open the enamel Then in caries removal from the walls carbon-steel rose-head bur. Finally the deeper caries will be removed using spoon excavator - Intervention : Biodentine™ (Septodont, St. Maur-des-Fossés, France) The material will be applied according to manufacturer instructions - Comparator: GC Fuji IX GP (GC America Inc, Alsip, IL, USA) The material will be applied according to manufacturer instructions - Final restoration application: Filtek™ Z250 Universal Restorative (3M Canada, London, Ontario Canada) -Adhesive system: Scotchbond Universal Etchant (3M ESPE, St. Paul MN, USA) & Single Bond Universal adhesive (3M ESPE, St. Paul MN, USA). - The material will be applied according to manufacturer instruction ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02868918
Study type Interventional
Source Cairo University
Contact
Status Completed
Phase Phase 3
Start date February 1, 2018
Completion date March 1, 2019
View Details
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