Clinical study of a newly developed bulk fill restorative material suitable for Class II restorations
- Conditions
- dental researchfilling of dental cavitiesrestoration of caries lesions
- Registration Number
- NL-OMON55890
- Lead Sponsor
- 3M Deutschland GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 55
- 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
- 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Evaluation of restoration survival based on the FDI Criteria.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Evaluation of restoration quality based on the FDI Criteria and evaluation of<br /><br>potential adverse effects.</p><br>