Clinical Performance of Short Fiber Reinforced Flowable Resin Composite Restorations 2y RCT

January 22, 2021 updated by: Rawda Hesham Abd ElAziz, Cairo University

Clinical Performance of Short Fiber Reinforced Flowable Resin Composite Restorations Versus Conventional Resin Composite Restorations in Posterior Teeth (2y Randomized Clinical Trial)

Clinical performance of short fiber reinforced flowable resin composite restorations versus conventional resin composite restorations will be tested in posterior teeth (2y randomized clinical trial).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

70

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

Study Locations

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

17 years to 55 years (ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with large proximal carious cavities in molars.
  • Pulp asymptomatic vital carious upper or lower molars.
  • Good oral hygiene.

Exclusion Criteria:

  • Presence of signs and symptoms of irreversible pulpitis or pulp necrosis
  • Severe medical complications.
  • Allergic history concerning methacrylates
  • Evidence of parafunctional habits.

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
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Short fiber reinforced flowable resin composite restorations
(everX Flow, GC Europe) + (Gaenial posterior, GC Europe
Other: Short fiber reinforced flowable resin composite restorations
reinforced flowable resin composite
Other Names:
  • Ever X Flow
ACTIVE_COMPARATOR: Conventional resin composite restoration.
(Gaenial posterior, GC Europe)
Other: Conventional resin composite restoration
Microhybrid resin composite
Other Names:
  • Gaenial posterior, GC Europe

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical performance (Alpha is the best score, bravo, charlie the worst score)
Time Frame: Change from baseline at 6, 12 ,18, 24 months

Modified USPHS criteria; . Post operative Hypersensitivity

Secondary caries

Gross fracture

Color match

Cavo-surface marginal discoloration

Marginal integrity

Proximal contact
Change from baseline at 6, 12 ,18, 24 months

Collaborators and Investigators

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

Sponsor

Cairo University

Investigators

  • Principal Investigator: Rawda Hesham, Lecturer at faculty of Dentistry- 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 (ANTICIPATED)

March 1, 2021

Primary Completion (ANTICIPATED)

April 1, 2023

Study Completion (ANTICIPATED)

June 1, 2023

Study Registration Dates

First Submitted

January 19, 2021

First Submitted That Met QC Criteria

January 21, 2021

First Posted (ACTUAL)

January 22, 2021

Study Record Updates

Last Update Posted (ACTUAL)

January 26, 2021

Last Update Submitted That Met QC Criteria

January 22, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CU-1-2021

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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