Glass Hybrid Versus Composite Restorations of Non-carious Cervical Lesions

Charité University Medicine Berlin

Status: Completed

Conditions: Dental Cervical Non-carious Lesion

Treatments: Other: Equia Forte; Other: Filtek Supreme XT/Clearfil SE Bond

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02631161

GHyComp

Details and patient eligibility

About

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.

Full 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.

Enrollment: 88 patients

Sex: All

Ages: 50 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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88 participants in 2 patient groups

EQUIA forte

Experimental group

Description:

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

Treatment:

Other: Equia Forte

Filtek Supreme XT/Clearfil SE Bond

Active Comparator group

Description:

Dental non-carious cervical restorations are being restored with a composite resin based material/Adhesive combination (Medical product: Filtek Supreme XT/Clearfil SE Bond).

Treatment:

Other: Filtek Supreme XT/Clearfil SE Bond