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CompletedNCT04288791Updated Mar 17, 2020

Evaluation of the Clinical Performance of Reinforced Glass Ionomer Restorations

An interventional study of Equia Forte Fil and Zirconomer Improved in Dental Caries, sponsored by Al-Azhar University. Completed at 1 site in Egypt. Open to participants aged 20 Years to 47 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-03-17.

Sponsored by Al-Azhar University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 8 months after the study started (first participant enrolled Jun 2018, registered Feb 2020).
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
20 Years to 47 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Dental Caries

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03

In context

Dental Caries

1,107 studies on the registry are indexed under Dental Caries; 197 are open to participants now.

This study's enrollment of 20 is below the median of 60 across 915 interventional studies indexed under Dental Caries.

Browse Dental Caries studies →

Lead sponsor

Al-Azhar University is the lead sponsor of 505 studies on the registry; 167 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 47 Years
Sexes eligible
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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
20 participants (actual)

Study arms

  • Experimental
    Equia Forte Fil

    Other: Equia Forte Fil · Other: Zirconomer Improved

  • Experimental
    Zirconomer Improved

    Other: Equia Forte Fil · Other: Zirconomer Improved

Interventions

  • OtherEquia 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.

  • OtherZirconomer 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 .

06

What researchers measure

Primary outcomes

  1. Clinical Performance of the restoration

    Success Rate

    Time frame: 6 months

07

Study locations

1 site
  • Al-Azhar University, Faculty of Dentistry For Girls
    Cairo, Egypt
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 17, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04288791
Lead sponsor
Al-Azhar University
Responsible party
Nessma Mohamed Mahmoud Sedky (Principle Investigator, Al-Azhar University) — Principal investigator
First posted
Feb 28, 2020
Start date
Jun 1, 2018
Primary completion
Aug 1, 2018
Completion
Feb 1, 2019
Last update
Mar 17, 2020

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.

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