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| Name | Class |
|---|---|
| GC Europe | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EQUIA forte | Experimental | Dental non-carious cervical restorations are being restored with a glass hybrid restorative system (Medical product: EQUIA forte). |
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| Filtek Supreme XT/Clearfil SE Bond | Active Comparator | Dental non-carious cervical restorations are being restored with a composite resin based material/Adhesive combination (Medical product: Filtek Supreme XT/Clearfil SE Bond). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Equia Forte | Other | Restoration of cavities with a Glasshybrid material (Equia Forte) |
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sebastian Paris, Prof. Dr. | Abteilung für Zahnerhaltung und Präventivzahnmedizin, Charité Berlin | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Charité Centrum für Zahn-, Mund- und Kieferheilkunde, Abteilung für Zahnerhaltungskunde und Präventivzahnmedizin | Berlin | 14197 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34817964 | Derived | 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. | |
| 33979577 | Derived | 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. |
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| Filtek Supreme XT/Clearfil SE Bond |
| Other |
Restoration of cavities with a composite resin based material after placing an adhesive |
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| recorded initially and, if required, each re-treatment appointment, over the total trial period (i.e. expected 36 months) |