K02.9
Conditions
Interventions
Group 1: 3M™ Filtek™ Universal Restorative (Class III and IV)
1. Restoration placement 60 min: preparation of tooth and restoration according instructions of use, photographic documentation
2. Baselin
Sponsors
Solventum
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Subject is at least 18 years or older at time of consent. 2. Subject and the subject’s legally designated representative (if applicable) is able to provide their own informed consent. 3. Subject is willing to return for follow-up examination for at least 2 years 4. Subject needs at least either one class III or one class IV restoration 5. Subjects study teeth must have a good prognosis for the next 3 years (e.g., 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 with PBI = 30%) 6. Subject meets the Level-I or Level-II classification criteria of the American Society of Anesthesiologists (ASA) Physical Status Classification System For Dental Patient Care
Exclusion criteria
Exclusion criteria: 1. Subjects tooth needs a repair of an already existing class III or class IV restoration 2. Subject has a known allergies to acrylate-based materials 3. Subject is enrolled in another clinical trial at the time of screening that would interfere with this study 4. Subject is experiencing sensitivity and pain of affected tooth 5. Pulpal exposure of tooth 6. Subject undergoing any orthodontic treatment 7. Subject is, in the opinion of the Investigator, unsuitable for enrollment in this study for reasons not specified in the exclusion criteria (e.g., acid erosion or dietary concerns, severe bruxism with loss of vertical height) 8.Subject cannot withhold the use of bleaching or tooth whitening products besides whitening toothpaste (e.g. carbamide peroxide or hydrogen peroxide gels, strips, trays, or in-office bleaching) during the study period
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Survival rates of class III and class IV restorations at 2 years. | — |
Secondary
| Measure | Time frame |
|---|---|
| Survival rates at 6 months and 1 year, the esthetic, functional and biological parameters per FDI criteria and annual failure rates. | — |
Countries
Germany
Contacts
Public ContactCornelia Frese
Universitätsklinikum Heidelberg
Outcome results
None listed