Clinical Performance of Zirconia Reinforced GI Versus Conventional Viscous GI in Geriatric Patients

February 5, 2024 updated by: Doaa Mohammed Mohammed Abdou, Cairo University

Clinical Evaluation of Zirconia Reinforced Versus Conventional Viscous Glass Ionomer in Posterior Restorations of Geriatric Patients: Randomized Controlled Trial

This study is conducted to evaluate the clinical performance of Zirconomer Improved GI restoration compared to Conventional viscous GI restoration in geriatric patients with Posterior carious lesions in class I or II cavities

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study will be conducted to determine the clinical performance of the Zirconia reinforced glass ionomer restorations ( Zirconomer improved) under stress bearing posterior area (class I or claa II cavities) in geriatric population in comparison to Conventional viscous glass ionomer restorations (Ketac molar quick Aplicap) using the modified United States Public Health Service (USPHS) criteria

P: Geriatric Patients with posterior Caries lesions I: Zirconia reinforced GI (Zirconomer Improved) C: Conventional viscous GI, (Ketac Molar quick Aplicap) O: The Clinical performance of the Glass Ionomer restorations Using USPHS Criteria

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Giza, Egypt, 12573
        • Doaa Abdou

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Age range 60-80 years
  • Geriatric patients with Class I or II Posterior carious lesions.
  • Males or Females.
  • Pulp asymptomatic vital carious posterior teeth.
  • Co-operative patients approving to participate in the trial.

Exclusion Criteria:

  • Age range less than 60 years.
  • Disabilities.
  • Deep extensive carious cavities that may lead to fracture of the tooth or pulpal affection.
  • Teeth with signs and symptoms of irreversible pulpitis or pulp necrosis.
  • Heavy smoking.
  • Lack of compliance.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: zirconomer improved
zirconia reinforced glass ionomer restoration
Drug: Zirconomer Improved
glass ionomer restoration reinforced with nano-zirconia particles to improve strength and esthetics
Other Names:
  • zirconia reinforced GI
Active Comparator: ketac molar quick aplicap
conventional viscous glass ionomer restoration
Drug: Ketac Molar quick Aplicap
highly viscous glass ionomer with improved mechanical properties than the conventional GI
Other Names:
  • KMQ aplicap

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical performance
Time Frame: 1 year
clinical performance of the Glass Ionomer restorations using modified USPHS criteria
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2021

Primary Completion (Actual)

September 1, 2022

Study Completion (Actual)

October 1, 2022

Study Registration Dates

First Submitted

March 4, 2020

First Submitted That Met QC Criteria

March 4, 2020

First Posted (Actual)

March 6, 2020

Study Record Updates

Last Update Posted (Actual)

February 6, 2024

Last Update Submitted That Met QC Criteria

February 5, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Zirconia GI Conventional GI

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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