Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 5:03 AM
Ignite Modification Date:
2025-12-25 @ 5:03 AM
NCT ID:
NCT02868918
Brief 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
Study:
NCT02868918
Study Brief:
Protocol Section:
NCT02868918