dental research filling of dental cavities restoration of caries lesions
Conditions
Interventions
The intervention of the study is treatment of a Class II restoration with a new
bulk fill material.
Sponsors
3M Deutschland GmbH
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Subject is between 18 and 70 years of age - Subject is in good general health and can be classified as ASA 1 or 2 - Subject is in need of at least one Class II restoration without cusp replacement. The restoration can be a replacement of a failed existing restoration - Study teeth must have a good prognosis for the next 3 years (no increased tooth mobility, periodontal probing depth is * 5 mm, no signs of pulpitis, no pulp exposure during treatment, study teeth are vital, level of oral hygiene is sufficient) - Each study restoration has at least one proximal contact and is stress bearing - Subject volunteers to participate in the study and is available for recalls during the 3 years study duration
Exclusion criteria
Exclusion criteria: - Subject does have known allergies against any study substances - Study teeth with bad prognosis (increased tooth mobility, periodontal probing depth is > 5 mm, signs of pulpitis, pulp exposure during treatment, non-vital teeth, level of oral hygiene is insufficient) - Subject undergoing treatment for bruxism, traumatic malocclusion, or erosion - Study teeth with pulp exposure - Subject being pregnant or breast feeding - Subject participating in other dental studies that might interfere with this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation of restoration survival based on the FDI Criteria. | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluation of restoration quality based on the FDI Criteria and evaluation of potential adverse effects. | — |
Countries
Netherlands
Outcome results
None listed