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Trial record 75 of 1200 for:    tooth decay

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

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
Deep Caries Drug: biodentine Drug: glass ionomer cement Device: DigoraH optium 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

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Study Type : Interventional  (Clinical Trial)
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 : February 1, 2017
Estimated Primary Completion Date : January 1, 2019
Estimated Study Completion Date : March 1, 2019

Resource links provided by the National Library of Medicine


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 Name: tricalcium silicate

Device: DigoraH optium
digital Xray for follow up
Other Name: 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 Name: Fuji ix

Device: DigoraH optium
digital Xray for follow up
Other Name: digital radiography




Primary Outcome Measures :
  1. postoperative hypersensitivity using yes or no questionnaire [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Biocompatibility of biodentine using digital X-ray [ Time Frame: 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02868918


Locations
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Egypt
Omnia Magdy
Cairo, Egypt, 02
Sponsors and Collaborators
Cairo University
Investigators
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Study Chair: Ahmed Elkhadem, PhD Cairo University

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Responsible Party: Omnia Magdy Moustafa, Assistant lecturer , Conservative Dentistry Department, Faculty of Oral & Dental Medicine Cairo University, Cairo University
ClinicalTrials.gov Identifier: NCT02868918     History of Changes
Other Study ID Numbers: CEBD-CU-2016-08-174
First Posted: August 16, 2016    Key Record Dates
Last Update Posted: October 18, 2018
Last Verified: October 2018

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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

Additional relevant MeSH terms:
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Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases
Methamphetamine
Central Nervous System Stimulants
Physiological Effects of Drugs
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Dopamine Uptake Inhibitors