Glass Hybrid Versus Composite Restorations of Non-carious Cervical Lesions

NCT ID: NCT02631161

Last Updated: 2021-06-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

88 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-31

Study Completion Date

2021-02-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Dental Cervical Non-carious Lesion

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

EQUIA forte

Dental non-carious cervical restorations are being restored with a glass hybrid restorative system (Medical product: EQUIA forte).

Group Type EXPERIMENTAL

Equia Forte

Intervention Type OTHER

Restoration of cavities with a Glasshybrid material (Equia Forte)

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).

Group Type ACTIVE_COMPARATOR

Filtek Supreme XT/Clearfil SE Bond

Intervention Type OTHER

Restoration of cavities with a composite resin based material after placing an adhesive

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Equia Forte

Restoration of cavities with a Glasshybrid material (Equia Forte)

Intervention Type OTHER

Filtek Supreme XT/Clearfil SE Bond

Restoration of cavities with a composite resin based material after placing an adhesive

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

50 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

GC Europe

INDUSTRY

Sponsor Role collaborator

Charite University, Berlin, Germany

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Falk Schwendicke

PD Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Sebastian Paris, Prof. Dr.

Role: STUDY_DIRECTOR

Abteilung für Zahnerhaltung und Präventivzahnmedizin, Charité Berlin

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Charité Centrum für Zahn-, Mund- und Kieferheilkunde, Abteilung für Zahnerhaltungskunde und Präventivzahnmedizin

Berlin, , Germany

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Germany

References

Explore related publications, articles, or registry entries linked to this study.

Gostemeyer G, Seifert T, Jeggle-Engbert LM, Paris S, Schwendicke F. Glass Hybrid Versus Nanocomposite for Restoration of Sclerotic Non-carious Cervical Lesions: 18-Month Results of a Randomized Controlled Trial. J Adhes Dent. 2021 Dec 3;23(6):487-496. doi: 10.3290/j.jad.b2287831.

Reference Type DERIVED
PMID: 34817964 (View on PubMed)

Schwendicke F, Muller A, Seifert T, Jeggle-Engbert LM, Paris S, Gostemeyer G. Glass hybrid versus composite for non-carious cervical lesions: Survival, restoration quality and costs in randomized controlled trial after 3 years. J Dent. 2021 Jul;110:103689. doi: 10.1016/j.jdent.2021.103689. Epub 2021 May 9.

Reference Type DERIVED
PMID: 33979577 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

GHyComp

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.