Glass Hybrid Versus Composite Restorations of Non-carious Cervical Lesions

Not Applicable

Completed

• Conditions: Dental Cervical Non-carious Lesion
• Interventions: Other: Equia Forte; Other: Filtek Supreme XT/Clearfil SE Bond

• Registration Number: NCT02631161
• Lead Sponsor: Charite University, Berlin, Germany

Brief Summary

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

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 Timeline

• Study Start: 2015-12
• Study First Submitted: 2015-12-07
• Study First Submitted QC: 2015-12-11
• Study First Posted: 2015-12-16
• Primary Completion: 2021-02-01
• Study Completion: 2021-02-01
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-16
• Last Update Posted: 2021-06-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 88

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
EQUIA forte	Equia Forte	Dental non-carious cervical restorations are being restored with a glass hybrid restorative system (Medical product: EQUIA forte).
Filtek Supreme XT/Clearfil SE Bond	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).

Primary Outcome Measures

Name	Time	Method
Number of restorations with a re-intervention per all restorations	36 months	Number of all restorations with a re-intervention being required per all placed restorations (events/sample)

Secondary Outcome Measures

Name	Time	Method
Costs for initial and retreatment	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
Restoration score	36 months	score according to FDI criteria

Trial Locations

Locations (1)

Charité Centrum für Zahn-, Mund- und Kieferheilkunde, Abteilung für Zahnerhaltungskunde und Präventivzahnmedizin; 🇩🇪 Berlin, Germany