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

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.

Study Overview

• Status: Completed
• Conditions: Deep Caries
• Intervention / Treatment: Drug: biodentine; Device: DigoraH optium; Drug: glass ionomer cement

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 Type: Interventional
• Enrollment (Actual): 120
• Phase: Phase 3

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 02
    • Omnia Magdy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Study Chair: Ahmed Elkhadem, PhD, Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2018
• Primary Completion (Actual): January 1, 2019
• Study Completion (Actual): March 1, 2019

Study Registration Dates

• First Submitted: August 6, 2016
• First Submitted That Met QC Criteria: August 15, 2016
• First Posted (Estimate): August 16, 2016

Study Record Updates

• Last Update Posted (Actual): September 15, 2022
• Last Update Submitted That Met QC Criteria: September 14, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Demineralization; Tooth Diseases; Dental Caries
• Other Study ID Numbers: CEBD-CU-2016-08-174

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No