Clinical Evaluation of Glass Ionomer With Glass Hybrid Technology Versus Conventional High Viscosity Glass Ionomer in Class I Cavities of High Caries Risk Patients

August 2, 2016 updated by: Mohamed Refaat El-Bialy, Cairo University

Clinical Evaluation of Glass Ionomer With Glass Hybrid Technology Versus Conventional High Viscosity Glass Ionomer in Class I Cavities of High Caries Risk Patients: Randomized Controlled Trial

PICOTS:

P: High Caries Risk Patients with bilateral class I cavities. I: Glass Ionomer with Glass Hybrid Technology. C: Conventional High Viscosity Glass Ionomer. O: Clinical performance (Functional properties Biological properties) using (World Dental Federation) Fédération dentaire internationale (FDI) criteria for dental restorations.

T: 1 year. S: Randomized controlled Trial (split mouth design). Research question:In high caries risk patients with class I cavities will glass ionomer with glass hybrid technology has similar clinical performance as conventional high viscosity glass ionomer

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

31

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 Locations

  • Egypt
      • Cairo, Egypt, 11553
        • faculty of oral and dental medicine, Cairo university

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

19 years to 50 years (Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Bilateral class I carious lesions in their occlusal pits and fissures.
  • High caries risk patients who has 1 or more cavitated lesion with risk factor declared by Caries Management By Risk Assessment (CAMBRA)
  • Co-operative patients approving to participate in the trial.

Exclusion Criteria:

  • Disabilities.
  • Systemic diseases or severe medically compromised.
  • Lack of compliance.
  • Evidence of severe bruxism, clenching or temporomandibular joint disorders

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
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Glass Ionomer with Glass Hybrid technology
Intervention
Other: Glass ionomer with glass hybrid technology
Dental restorative material
Other Names:
  • GC EQUIA Forte
Active Comparator: Conventional high viscosity Glass Ionomer
Comparator
Other: Conventional high viscosity glass ionomer
Dental restorative material
Other Names:
  • GC EQUIA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Clinical performance using FDI criteria for dental restorations (functional properties and biological properties)
Time Frame: 1 year
1 year

Collaborators and Investigators

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

Sponsor

Cairo University

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

Primary Completion (Anticipated)

September 1, 2018

Study Registration Dates

First Submitted

August 1, 2016

First Submitted That Met QC Criteria

August 2, 2016

First Posted (Estimate)

August 5, 2016

Study Record Updates

Last Update Posted (Estimate)

August 5, 2016

Last Update Submitted That Met QC Criteria

August 2, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CEBD-CU-2016-08-178

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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