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

Sponsor
Cairo University (Other)
Overall Status
Unknown status
CT.gov ID
NCT02868918
Collaborator
(none)
120
Enrollment
1
Location
2
Arms
24.9
Anticipated Duration (Months)
4.8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 3

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 Design

Study Type:
Interventional
Actual Enrollment :
120 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Health Services Research
Official Title:
Clinical and Radiographical Evaluation of New Bioactive Dentine Substitute (Biodentine) Versus Glass Ionomer Cement in Treatment of Very Deep Carious Lesions -Randomized Clinical Trial
Actual Study Start Date :
Feb 1, 2017
Anticipated Primary Completion Date :
Jan 1, 2019
Anticipated Study Completion Date :
Mar 1, 2019

Arms and Interventions

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

    Drug: glass ionomer cement
    high viscosity glass ionomer used as a base material
    Other Names:
  • Fuji ix

    • Device: DigoraH optium
    digital Xray for follow up
    Other Names:
  • digital radiography

    		•

    Outcome Measures

    Primary Outcome Measures

    1. postoperative hypersensitivity using yes or no questionnaire [6 months]

    Secondary Outcome Measures

    1. Biocompatibility of biodentine using digital X-ray [6 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Omnia Magdy Cairo Egypt 02

    Sponsors and Collaborators

    • Cairo University

    Investigators

    • Study Chair: Ahmed Elkhadem, PhD, Cairo University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Omnia Magdy Moustafa, Assistant lecturer , Conservative Dentistry Department, Faculty of Oral & Dental Medicine Cairo University, Cairo University
    ClinicalTrials.gov Identifier:
    NCT02868918
    Other Study ID Numbers:
    • CEBD-CU-2016-08-174
    First Posted:
    Aug 16, 2016
    Last Update Posted:
    Oct 18, 2018
    Last Verified:
    Oct 1, 2018
    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
    Additional relevant MeSH terms:
    Dental Caries

    Study Results

    No Results Posted as of Oct 18, 2018