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

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ClinicalTrials.gov Identifier: NCT02868918
Recruitment Status : Active, not recruiting
First Posted : August 16, 2016
Last Update Posted : October 18, 2018
Sponsor:
Information provided by (Responsible Party):
Omnia Magdy Moustafa, Cairo University

Tracking Information
First Submitted Date  ICMJE August 6, 2016
First Posted Date  ICMJE August 16, 2016
Last Update Posted Date October 18, 2018
Actual Study Start Date  ICMJE February 1, 2017
Estimated Primary Completion Date January 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 15, 2016)
postoperative hypersensitivity using yes or no questionnaire [ Time Frame: 6 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02868918 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 15, 2016)
Biocompatibility of biodentine using digital X-ray [ Time Frame: 6 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of Biodentine Versus Glass Ionomer Cement in Treatment of Very Deep Carious Lesions
Official Title  ICMJE Clinical and Radiographical Evaluation of New Bioactive Dentine Substitute (Biodentine) Versus Glass Ionomer Cement in Treatment of Very Deep Carious Lesions -Randomized Clinical Trial
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
Condition  ICMJE Deep Caries
Intervention  ICMJE
  • Drug: biodentine
    tricalcium silicate cement used to replace the carious dentin
    Other Name: tricalcium silicate
  • Drug: glass ionomer cement
    high viscosity glass ionomer used as a base material
    Other Name: Fuji ix
  • Device: DigoraH optium
    digital Xray for follow up
    Other Name: digital radiography
Study Arms  ICMJE
  • Experimental: biodentine
    bioactive dentin substitute used to act like natural dentin in insulating the pulp against external stimuli intervention
    Interventions:
    • Drug: biodentine
    • Device: DigoraH optium
  • Active Comparator: glass ionomer cement
    high viscosity glass ionomer used as a base material comparator other name : - fuji ix
    Interventions:
    • Drug: glass ionomer cement
    • Device: DigoraH optium
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: October 16, 2018)
120
Original Estimated Enrollment  ICMJE
 (submitted: August 15, 2016)
50
Estimated Study Completion Date  ICMJE March 1, 2019
Estimated Primary Completion Date January 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02868918
Other Study ID Numbers  ICMJE CEBD-CU-2016-08-174
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Omnia Magdy Moustafa, Cairo University
Study Sponsor  ICMJE Cairo University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Ahmed Elkhadem, PhD Cairo University
PRS Account Cairo University
Verification Date October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP