Evaluation of the Clinical Performance of Reinforced Glass Ionomer Restorations

Sponsor

Al-Azhar University (Other)

Overall Status

Completed

CT.gov ID

NCT04288791

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

2.5

Patients Per Site Per Month

Study Details

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)

Condition or Disease	Intervention/Treatment	Phase
Dental Caries	Other: Equia Forte Fil Other: Zirconomer Improved	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Evaluation of the Clinical Performance of Reinforced Glass Ionomer Restorations

Actual Study Start Date :

Jun 1, 2018

Actual Primary Completion Date :

Aug 1, 2018

Actual Study Completion Date :

Feb 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Equia Forte Fil	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. 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 .
Experimental: Zirconomer Improved	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. 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 .

Arm

Intervention/Treatment

Experimental: Equia Forte Fil

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.

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 .

Experimental: Zirconomer Improved

Other: Equia Forte Fil

Other: Zirconomer Improved

Outcome Measures

Primary Outcome Measures

Clinical Performance of the restoration [6 months]
Success Rate

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 47 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Al-Azhar University, Faculty of Dentistry For Girls	Cairo		Egypt

Sponsors and Collaborators

Al-Azhar University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Nessma Mohamed Mahmoud Sedky, Principle Investigator, Al-Azhar University

ClinicalTrials.gov Identifier:

NCT04288791

Other Study ID Numbers:

REC16-033

First Posted:

Feb 28, 2020

Last Update Posted:

Mar 17, 2020

Last Verified:

Mar 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Dental Caries

Study Results

No Results Posted as of Mar 17, 2020