K08
Conditions
Interventions
Group 1: 3M™ RelyX™ Universal for luting of the fiber post
1.treatment visit approx. 1h: Preparation of post space and insertion of fiber post 3M™RelyX™ Fiber Post 3D using luting agent 3M™ RelyX™ U
Sponsors
Solventum
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1 Subject is at least 18 or older at time of consent. 2 Subject is able to provide their own informed consent. 3 Subject is willing to return for follow-up examination for at least 5 years 4 Subject needs an indirect crown or 3-unit bridge restoration 5 Subject has a tooth with one or less cavity walls of the anatomical crown remaining 6 Subject’s tooth has a residual root canal thickness at the orifice of more than 1 mm 7 Subject’s tooth is symptom free with a root canal filling without a radiologically visible periapical lesion. 8 Subject’s tooth has the possibility to prep a 2 mm ferrule 9 Subject’s tooth has a minimum of 8 mm post length within the root canal, with a minimum of 4 mm apical root canal filling 10 Subject’s tooth has no or treated periodontitis with maximum probing depth of 4 mm and no bleeding on probing 11 Subject’s tooth mobility is not more than score II 12 Subject’s tooth has at least one antagonist tooth 13 Patient is willing to pay for a full ceramic restoration (single crown: lithium disilicate, bridge: zirconia)
Exclusion criteria
Exclusion criteria: 1 Subject has a known allergies to acrylate-based materials or hydroperoxide 2 Subject is enrolled in another clinical trial at the time of screening that would interfere with this study 3 Subject’s tooth is aimed to serve as telescopic crown abutment. 4 Subjects is in the opinion of the Investigator unsuitable for enrollment in this study for reasons not specified in the exclusion criteria 5 Subject does not sign the informed consent form
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint will be the retention rate of the glass-fiber post (post in situ) at 2 years. | — |
Secondary
| Measure | Time frame |
|---|---|
| Retention rate of the glass-fiber post (post in situ) at 6 months, 1 year, 3 years (optional), 4 years, (optional), and 5 years (optional) | — |
Countries
Germany
Contacts
Public ContactGuido Sterzenbach
Charité-Universitätsmedizin Berlin
Outcome results
None listed