Evaluation of the Clinical Performance of Reinforced Glass Ionomer Restorations
1 other identifier
interventional
20
1 country
1
Brief Summary
This study is conducted to evaluate the clinical performance of class I reinforced glass ionomer restorations (Zirconomer Improved and Equia Forte Fil)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2018
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2019
CompletedFirst Submitted
Initial submission to the registry
February 26, 2020
CompletedFirst Posted
Study publicly available on registry
February 28, 2020
CompletedMarch 17, 2020
March 1, 2020
2 months
February 26, 2020
March 15, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Clinical Performance of the restoration
Success Rate
6 months
Study Arms (2)
Equia Forte Fil
EXPERIMENTALZirconomer Improved
EXPERIMENTALInterventions
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 .
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Al-Azhar University, Faculty of Dentistry For Girls
Cairo, Egypt
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principle Investigator
Study Record Dates
First Submitted
February 26, 2020
First Posted
February 28, 2020
Study Start
June 1, 2018
Primary Completion
August 1, 2018
Study Completion
February 1, 2019
Last Updated
March 17, 2020
Record last verified: 2020-03