Glass Hybrid Versus Composite Restorations of Non-carious Cervical Lesions

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Dental Cervical Non-carious Lesion

Intervention / Treatment
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* Other: Equia Forte
* Other: Filtek Supreme XT/Clearfil SE Bond


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EQUIA forte<br>Dental non-carious cervical restorations are being restored with a glass hybrid restorative system (Medical product: EQUIA forte). | Other: Equia Forte<br>* Restoration of cavities with a Glasshybrid material (Equia Forte)<br>|
| Active Comparator: Filtek Supreme XT/Clearfil SE Bond<br>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<br>* Restoration of cavities with a composite resin based material after placing an adhesive<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of restorations with a re-intervention per all restorations | 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 | score according to FDI criteria | 36 months | 
| Costs for initial and retreatment | 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) |