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

Phase 3

Completed

• Conditions: Deep Caries
• Interventions: Drug: biodentine; Drug: glass ionomer cement; Device: DigoraH optium

• Registration Number: NCT02868918
• Lead Sponsor: Cairo University

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 Timeline

• Study First Submitted: 2016-08-06
• Study First Submitted QC: 2016-08-15
• Study First Posted: 2016-08-16
• Study Start: 2018-02-01
• Primary Completion: 2019-01-01
• Study Completion: 2019-03-01
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-14
• Last Update Posted: 2022-09-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

1. Patients male or female older than 18 y in good general health
2. 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
3. Clinical symptoms of reversible pulpitis
4. Positive pulp response to electric pulp test or thermal stimulation
5. No PA changes viewed on PA radiograph

Exclusion Criteria

1. Clinical symptoms of irreversible pulpitis requiring endodontic treatment
2. Presence of fistulas or swelling
3. Mobile teeth or tenderness to percussion
4. Anterior teeth with aesthetic concerns
5. Pregnant women, in view of requirements for radiographs
6. Patients younger than 18 y
7. Patients unable to give consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
biodentine	biodentine	bioactive dentin substitute used to act like natural dentin in insulating the pulp against external stimuli intervention
biodentine	DigoraH optium	bioactive dentin substitute used to act like natural dentin in insulating the pulp against external stimuli intervention
glass ionomer cement	glass ionomer cement	high viscosity glass ionomer used as a base material comparator other name : - fuji ix
glass ionomer cement	DigoraH optium	high viscosity glass ionomer used as a base material comparator other name : - fuji ix

Primary Outcome Measures

Name	Time	Method
postoperative hypersensitivity using yes or no questionnaire	6 months

Secondary Outcome Measures

Name	Time	Method
Biocompatibility of biodentine using digital X-ray	6 months

Trial Locations

Locations (1)

Omnia Magdy; 🇪🇬 Cairo, Egypt