Glass Hybrid Versus Composite Restorations of Non-carious Cervical Lesions

June 16, 2021 updated by: Falk Schwendicke, Charite University, Berlin, Germany

Randomized Controlled Trial on Glass Hybrid Versus Composite Restorations of Non-carious Cervical Lesions

A glass hybrid restorative system (EQUIA forte) clinically compared to a composite resin based material (Clearfil SE Bond, Filtek Supreme XT) for the treatment of dental non-carious cervical lesions.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a prospective, randomized, monocenter parallel group study on restoration of tooth with non-carious cervical restorations. Each patient receives cervical restoration(s) either with glass hybrid EQUIA forte or with composite resin/adhesive combination Filtek Supreme XT/Clearfil SE Bond in anterior/posterior tooth region. Restorations will be provided by one experienced operator. One of two independent examiners will evaluate the restorations at baseline (1 week after placement), and after 18, and 36 months according to the FDI criteria. Reliability of examination will be assessed on a random sample of 30 restorations.

Study Type

Interventional

Enrollment (Actual)

88

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

  • Germany
      • Berlin, Germany, 14197
        • Charité Centrum für Zahn-, Mund- und Kieferheilkunde, Abteilung für Zahnerhaltungskunde und Präventivzahnmedizin

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

50 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • indication of a restorative treatment for a sclerotic non-carious cervical lesion
  • lesions should be accessible for treatment and visual-tactile re-evaluation
  • sufficient moisture control should be possible
  • cervical margins should be located in dentin whereas the coronal margin should be located in enamel

Exclusion Criteria:

  • allergy/hypersensitivity against any of the used materials
  • participants should not be systematically ill, disabled, pregnant or participating in another study

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: EQUIA forte
Dental non-carious cervical restorations are being restored with a glass hybrid restorative system (Medical product: EQUIA forte).
Other: Equia Forte
Restoration of cavities with a Glasshybrid material (Equia Forte)
Active Comparator: Filtek Supreme XT/Clearfil SE Bond
Dental non-carious cervical restorations are being restored with a composite resin based material/Adhesive combination (Medical product: Filtek Supreme XT/Clearfil SE Bond).
Other: Filtek Supreme XT/Clearfil SE Bond
Restoration of cavities with a composite resin based material after placing an adhesive

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of restorations with a re-intervention per all restorations
Time Frame: 36 months
Number of all restorations with a re-intervention being required per all placed restorations (events/sample)
36 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Restoration score
Time Frame: 36 months
score according to FDI criteria
36 months
Costs for initial and retreatment
Time Frame: recorded initially and, if required, each re-treatment appointment, over the total trial period (i.e. expected 36 months)
Costs incurred for staff and material for initial and re-treatments
recorded initially and, if required, each re-treatment appointment, over the total trial period (i.e. expected 36 months)

Collaborators and Investigators

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

Sponsor

Charite University, Berlin, Germany

Collaborators

GC Europe

Investigators

  • Study Director: Sebastian Paris, Prof. Dr., Abteilung für Zahnerhaltung und Präventivzahnmedizin, Charité Berlin

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)

December 1, 2015

Primary Completion (Actual)

February 1, 2021

Study Completion (Actual)

February 1, 2021

Study Registration Dates

First Submitted

December 7, 2015

First Submitted That Met QC Criteria

December 11, 2015

First Posted (Estimate)

December 16, 2015

Study Record Updates

Last Update Posted (Actual)

June 18, 2021

Last Update Submitted That Met QC Criteria

June 16, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • GHyComp

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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