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

Study Overview
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Brief Summary
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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.

Detailed Description
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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 : Thermal testing using Refrigerant spray percussion test Palpation and clinical examination 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

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

Conditions
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Deep Caries

Intervention / Treatment
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* Drug: biodentine
* Drug: glass ionomer cement
* Device: DigoraH optium


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients male or female older than 18 y in good general health A minimum of 1 deep carious lesion penetrating three-quarters or more into the dentine as identified with the periapical (PA) radiograph; Clinically according to International Caries Detection and Assessment System (ICDAS II) score 4 Clinical symptoms of reversible pulpitis Positive pulp response to electric pulp test or thermal stimulation No PA changes viewed on PA radiograph Exclusion Criteria: Clinical symptoms of irreversible pulpitis requiring endodontic treatment Presence of fistulas or swelling Mobile teeth or tenderness to percussion Anterior teeth with aesthetic concerns Pregnant women, in view of requirements for radiographs Patients younger than 18 y Patients unable to give consent

Ages Eligible for Study
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Minimum Age: 18 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: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: biodentine<br>bioactive dentin substitute used to act like natural dentin in insulating the pulp against external stimuli intervention | Drug: biodentine<br>* tricalcium silicate cement used to replace the carious dentin<br>* Other names: tricalcium silicate;Device: DigoraH optium<br>* digital Xray for follow up<br>* Other names: digital radiography;|
| Active Comparator: glass ionomer cement<br>high viscosity glass ionomer used as a base material comparator other name : - fuji ix | Drug: glass ionomer cement<br>* high viscosity glass ionomer used as a base material<br>* Other names: Fuji ix;Device: DigoraH optium<br>* digital Xray for follow up<br>* Other names: digital radiography;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative hypersensitivity using yes or no questionnaire |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biocompatibility of biodentine using digital X-ray |  | 6 months |