NCT02868918

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Cairo University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed 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

Conditions

• Deep Caries

Interventions

Type	Name	Description
DRUG	biodentine	tricalcium silicate cement used to replace the carious dentin
DRUG	glass ionomer cement	high viscosity glass ionomer used as a base material
DEVICE	DigoraH optium	digital Xray for follow up

Timeline

• Start date: 2018-02-01
• Primary completion: 2019-01-01
• Completion: 2019-03-01
• First posted: 2016-08-16
• Last updated: 2022-09-15

Locations

1 site across 1 country: Egypt

Regulatory

• FDA-regulated drug study
• FDA-regulated device study