Clinical and Radiographic Evaluation of Zirconomer Restorative (Zirconomer)

July 21, 2024 updated by: Tamador Ahmed Ibrahim, Cairo University

Clinical and Radiographic Evaluation of Zirconomer Restorative Material Versus a Glass Ionomer Cement in Restoration of Primary Molars A Randomized Clinical Trial

Is zirconomer restorative material more effective than a glass ionomer cement in restoration of primary molars

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This trial seeks to evaluate the clinical and radiographic performance of two materials zirconomer restorative material and glass ionomer cement to achieve better treatment for primary molars.

Study Type

Interventional

Enrollment (Estimated)

24

Phase

  • Not Applicable

Contacts and Locations

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

Study Contact

Study Contact Backup

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

  • Child

Accepts Healthy Volunteers

No

Description

  • Inclusion criteria:

    1. Children having carious primary molars(class1) without pulp exposure and normal radiograph.
    2. Children between age 5 and 7 years.
    3. Both male and female are included.

    4. Cooperative Children.

      Exclusion criteria:

    1. Patients with systemic diseases.
    2. Parent refuse to participate.

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: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Zirconomer Restorative material in primary molar
Arm one zirconomer restorative material (intervention)
Other: zirconia reinforced glass ionomer
Restorative material
Other Names:
  • zirconomer
Active Comparator: Glass Ionomer Cement in primary molar
Arm two Glass Ionomer cement (control)
Other: Glass ionomer cement
Restorative material
Other Names:
  • GIC

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recurrent CariesColor match
Time Frame: 12 MONTHS
Radiographic Visual inspection using Modified United States Public Health Service Ryge criteria USPHS
12 MONTHS

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Color match
Time Frame: 12 MONTHS
visual inspection using Modified United States Public Health Service Ryge criteria USPHS
12 MONTHS
Marginal Discoloration
Time Frame: 12 MONTHS
using visual inspection Modified United States Public Health Service Ryge criteria USPHS
12 MONTHS
Marginal Adaptation
Time Frame: 12 MONTHS
using visual inspection Modified United States Public Health Service Ryge criteria USPHS
12 MONTHS
-Anatomic Form
Time Frame: 12 MONTHS
using visual inspection Modified United States Public Health Service Ryge criteria USPHS
12 MONTHS

Collaborators and Investigators

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

Sponsor

Cairo University

Investigators

  • Study Director: sherien ez zaldein, professor, 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 (Estimated)

October 1, 2024

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

January 3, 2025

Study Registration Dates

First Submitted

January 30, 2024

First Submitted That Met QC Criteria

February 8, 2024

First Posted (Actual)

February 12, 2024

Study Record Updates

Last Update Posted (Actual)

July 23, 2024

Last Update Submitted That Met QC Criteria

July 21, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Evaluation of zirconomer
  • Cairo University (Other Identifier: Cairo University)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

study protocol and statistical analysis

IPD Sharing Time Frame

after one year

IPD Sharing Access Criteria

with other investigator including who will work with systematic review ,will provide the clinical study report with the documents above

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

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.

Clinical Trials on Dental Caries in Children

Clinical Trials on zirconia reinforced glass ionomer

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mongolia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe