K02
Conditions
Interventions
Group 1: Restoration of a carious lesion or replacement of a defect restoration in the posterior region with an established bulkfill restorative.
Group 2: Restoration of a carious lesion or replacemen
Sponsors
3M Deutschland GmbH 3M Oral Care
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Subject is between 18 and 75 years of age 2. Subject is in good general health (ASAa 1 or 2) 3. Subject does not have known allergies against any study substances 4. Subject is in need of a Class II restoration on at least 2 teeth 5. Both study teeth must have no increased tooth mobility (not more than 0-I). 6. Periodontal probing depth is =5.5 mm (CPITN explorer). 7. Both study teeth must have no signs of pulpitis, 8. Teeth with pulp exposure during treatment are excluded. 9. Study teeth are vital. 10. Level of oral hygiene is sufficient (PBI= 30%) 11. In case study restorations are in antagonistic contact with each other: each study restoration has at least one antagonistic occlusal contact to natural tooth substance 12. Subject does not suffer from bruxism (i.e. wears a mouth guard or should wear a mouth guard) or from traumatic malocclusion 13. Each study restoration has at least one proximal contact and is stress bearing. 14. Subject does not have excessive dietary or environmental exposure to acids or suffer from eating disorders (BEWE Index 0-I) 15. Subject is not pregnant or breast feeding at the time of placement of the restoration. 16. Subject volunteers to participate in the study and is available for recalls during the 3 years’ study duration (optional: 5y) 17. Subject does not participate in any other study at time of restoration placement.
Exclusion criteria
Exclusion criteria: 1. Subject is not in good general health (ASA >2) 2. Subject does have known allergies against any study substances 3. Study teeth have increased tooth mobility (more than I). 4. Periodontal probing depth is greater than 5.5 mm (CPITN explorer). 5. One or both study teeth show signs of pulpitis, 6. Pulp exposure happens during restorative treatment during caries removal. 7. Study teeth are not vital or are endodontically treated. 8. Level of oral hygiene is not sufficient (PBI>30%) 9. In case study restorations are in antagonistic contact with each other: the study restorations have no antagonistic occlusal contact to natural tooth substance 10. Subject suffers from bruxism (i.e. wears a mouth guard or should wear a mouth guard) or from traumatic malocclusion 11. Subject does have excessive dietary or environmental exposure to acids or suffers from eating disorders (BEWE Index>I) 12. Study restorations have no proximal contact or are not stress bearing. 13. Subject is pregnant or breast feeding at the time of placement of the restoration. 14. Subject has not given written informed consent to participate and be available for the next 3 years. 15. Subject does participate in another study at time of restoration placement.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation of the restoration quality and clinical performance based on the FDI criteria (marginal integrity, marginal discoloration, fracture, wear, color match, hypersensitivities) at baseline and after 6 months as well as 1, 2 and 3 years. | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluation of restoration survival based on recording of the respective FDI Criteria at the baseline, 6 months and 1, 2 and 3 year recalls and Kaplan Meier Survival Analysis after 3 years | — |
Countries
Germany
Contacts
Public ContactMarianne Federlin
Universitätsklinikum Regensburg Poliklinik für Zahnerhaltung und Parodontologie
Outcome results
None listed