Evaluation of the Clinical Performance of Reinforced Glass Ionomer Restorations

NCT ID: NCT04288791

Last Updated: 2020-03-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-01

Study Completion Date

2019-02-01

Brief Summary

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

Detailed Description

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Conditions

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Dental Caries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Equia Forte Fil

Group Type EXPERIMENTAL

Equia Forte Fil

Intervention Type OTHER

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

Intervention Type OTHER

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 .

Zirconomer Improved

Group Type EXPERIMENTAL

Equia Forte Fil

Intervention Type OTHER

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

Intervention Type OTHER

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 .

Interventions

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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.

Intervention Type OTHER

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 .

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

47 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Al-Azhar University

OTHER

Sponsor Role lead

Responsible Party

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Nessma Mohamed Mahmoud Sedky

Principle Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Al-Azhar University, Faculty of Dentistry For Girls

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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REC16-033

Identifier Type: -

Identifier Source: org_study_id

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