- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04288791
Evaluation of the Clinical Performance of Reinforced Glass Ionomer Restorations
March 15, 2020 updated by: Nessma Mohamed Mahmoud Sedky, Al-Azhar University
This study is conducted to evaluate the clinical performance of class I reinforced glass ionomer restorations (Zirconomer Improved and Equia Forte Fil)
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Cairo, Egypt
- Al-Azhar University, Faculty of Dentistry for Girls
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 47 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Equia Forte Fil
|
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.
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 .
|
Experimental: Zirconomer Improved
|
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.
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 .
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinical Performance of the restoration
Time Frame: 6 months
|
Success Rate
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 1, 2018
Primary Completion (Actual)
August 1, 2018
Study Completion (Actual)
February 1, 2019
Study Registration Dates
First Submitted
February 26, 2020
First Submitted That Met QC Criteria
February 27, 2020
First Posted (Actual)
February 28, 2020
Study Record Updates
Last Update Posted (Actual)
March 17, 2020
Last Update Submitted That Met QC Criteria
March 15, 2020
Last Verified
March 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC16-033
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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