Back to resultsEvaluation of the Clinical Performance of Reinforced Glass Ionomer Restorations
Primary Purpose
Dental Caries
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Equia Forte Fil
Zirconomer Improved
Sponsored by
About this trial
This is an interventional treatment trial for Dental Caries
Eligibility Criteria
Inclusion Criteria:
- Normal occlusal relation with normal dentition.
- Absence of pain from the tooth to be restored.
- Absence of any active periodontal and pulpal diseases from the tooth to be restored.
- Medium-sized (buccolingually and mesio-distally) occlusal carious lesions extending into dentin.
Exclusion Criteria:
- Patients with a history of tooth sensitivity.
- Patients with bruxism.
- Defective restorations adjacent or opposing to the tooth.
- Abutment teeth used for fixed or removable prosthesis.
- Patients who refused to sign the consent form.
- Inability to return to recall appointments
Sites / Locations
- Al-Azhar University, Faculty of Dentistry For Girls
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Equia Forte Fil
Zirconomer Improved
Arm Description
Outcomes
Primary Outcome Measures
Clinical Performance of the restoration
Success Rate
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04288791
Brief Title
Evaluation of the Clinical Performance of Reinforced Glass Ionomer Restorations
Official Title
Evaluation of the Clinical Performance of Reinforced Glass Ionomer Restorations
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
June 1, 2018 (Actual)
Primary Completion Date
August 1, 2018 (Actual)
Study Completion Date
February 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Al-Azhar University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study is conducted to evaluate the clinical performance of class I reinforced glass ionomer restorations (Zirconomer Improved and Equia Forte Fil)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Caries
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Equia Forte Fil
Arm Type
Experimental
Arm Title
Zirconomer Improved
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Equia Forte Fil
Intervention Description
Glass hybrid innovation achieved through the introduction of ultrafine, highly reactive glass particles dispersed with conventional GI. The restoration is coated with Equia Forte coat which incorporates multi-functional monomer producing a tougher resin matrix. This system is designed as alternative of amalgam in posterior teeth.
Intervention Type
Other
Intervention Name(s)
Zirconomer Improved
Intervention Description
Zirconia reinforced GI, Glass Polyalkenoate restoration; it is designed to exhibit high strength where the glass component of this GI undergoes finely controlled micronization to achieve optimum particle size and characteristics .
Primary Outcome Measure Information:
Title
Clinical Performance of the restoration
Description
Success Rate
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
47 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Normal occlusal relation with normal dentition.
Absence of pain from the tooth to be restored.
Absence of any active periodontal and pulpal diseases from the tooth to be restored.
Medium-sized (buccolingually and mesio-distally) occlusal carious lesions extending into dentin.
Exclusion Criteria:
Patients with a history of tooth sensitivity.
Patients with bruxism.
Defective restorations adjacent or opposing to the tooth.
Abutment teeth used for fixed or removable prosthesis.
Patients who refused to sign the consent form.
Inability to return to recall appointments
Facility Information:
Facility Name
Al-Azhar University, Faculty of Dentistry For Girls
City
Cairo
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Evaluation of the Clinical Performance of Reinforced Glass Ionomer Restorations
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