Clinical Performance of Short Fiber Reinforced Resin Modified Glass Ionomer Restorations in Cervical Carious Teeth (1y Randomized Clinical Trial)

February 19, 2024 updated by: Rawda Hesham Abd ElAziz, Cairo University

Clinical Performance of Short Fiber Reinforced Resin Modified Glass Ionomer Restorations Versus Resin Modified Glass Ionomer Restorations in Cervical Carious Teeth (1y Randomized Clinical Trial)

This research proposal is introduced to clinically test short fiber reinforced glass ionomer material from GC Europe due to gap of knowledge present in this area. It is characterized by higher flexural strength compared to resin modified glass ionomer (RMGIC). Additionally, the short fibers provided effective toughening of the RMGIC matrix by a fiber bridging mechanism.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

80

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, 11331
        • Faculty of Dentistry

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

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Patients with untreated cervical carious lesions
  • Patients with normal occlusion
  • Vital teeth with carious cervical lesion with asymptomatic vital pulp.
  • Teeth with no or minimum mobility.
  • Teeth with normal occlusion.
  • Teeth with surrounding healthy gingiva and supporting-structures.

Exclusion Criteria:

  • Patients who are unable to return for recall appointments
  • Presence of abnormal oral, medical or mental conditions.
  • Patients with severe medical diseases.
  • Patients with xerostomia
  • Patients with parafunctional habits.

  • Teeth with signs and symptoms of irreversible pulpitis or pulp necrosis.

    • Severe periodontal problems.
    • Non carious cervical lesions.

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: Single Group Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Short fiber reinforced resin modified glass ionomer restorations (GC Europe)
Procedure: restoration of cervical carious teeth
restoration of carious cervical lesions by glass ionomer
Active Comparator: Resin modified glass ionomer restoration. (Fugi II LC, GC Europe)
Procedure: restoration of cervical carious teeth
restoration of carious cervical lesions by glass ionomer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Marginal integrity score
Time Frame: [Time Frame: Baseline, 6 months, 12 months]
Modified USPHS criteria with Alpha, Bravo and Charlie scores (Categorical)
[Time Frame: Baseline, 6 months, 12 months]

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Marginal discoloration, Color match, Gross fracture scores
Time Frame: [Time Frame: Baseline, 6 months, 12 months]
Modified USPHS criteria with Alpha, Bravo and Charlie scores (Categorical)
[Time Frame: Baseline, 6 months, 12 months]
Change in Secondary caries scores
Time Frame: [Time Frame: Baseline, 6 months, 12 months]
Modified USPHS criteria with Alpha and Charlie scores (Categorical)
[Time Frame: Baseline, 6 months, 12 months]
Change in Post operative Hypersensitivity
Time Frame: [Time Frame: Baseline, 7 days, 6 months]
Modified USPHS criteria with Alpha and Charlie scores (Categorical)
[Time Frame: Baseline, 7 days, 6 months]

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

Study Start (Actual)

March 1, 2022

Primary Completion (Actual)

April 1, 2023

Study Completion (Actual)

December 28, 2023

Study Registration Dates

First Submitted

December 15, 2023

First Submitted That Met QC Criteria

December 28, 2023

First Posted (Actual)

December 29, 2023

Study Record Updates

Last Update Posted (Actual)

February 20, 2024

Last Update Submitted That Met QC Criteria

February 19, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CEBD 5/2022

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.

Clinical Trials on Cervical Caries

Clinical Trials on restoration of cervical carious teeth

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Belgium

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe