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NCT04288791 Clinical Trial

Evaluation of the Clinical Performance of Reinforced Glass Ionomer Restorations

Dental Caries Clinical Trial

Official title:
Evaluation of the Clinical Performance of Reinforced Glass Ionomer Restorations

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04288791
Other study ID # REC16-033
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 1, 2018
Est. completion date February 1, 2019

Study information
Verified date March 2020
Source Al-Azhar University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study is conducted to evaluate the clinical performance of class I reinforced glass ionomer restorations (Zirconomer Improved and Equia Forte Fil)

Recruitment information / eligibility
Status Completed
Enrollment 20
Est. completion date February 1, 2019
Est. primary completion date August 1, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 47 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Other:
• 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.
• Zirconomer Improved
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 .

Locations
Country Name City State
Egypt Al-Azhar University, Faculty of Dentistry For Girls Cairo

Sponsors (1)
Lead Sponsor Collaborator
Al-Azhar University

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary Clinical Performance of the restoration Success Rate 6 months
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