NL-OMON55890
Completed
Not Applicable
Clinical study of a newly developed bulk fill restorative material suitable for Class II restorations - Study of a bulk fill material for Class II restorations
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- dental research
- Sponsor
- 3M Deutschland GmbH
- Enrollment
- 55
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
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
Outcomes
Primary Outcomes
Not specified
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