Randomized controlled trial to compare the clinical performance of two self-adhesive resin cements when used with a fiber post and core build-up in endodontically treated teeth
- Conditions
- K08Other disorders of teeth and supporting structures
- Registration Number
- DRKS00028965
- Lead Sponsor
- 3M Deutschland GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 72
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)
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
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary endpoint will be the retention rate of the glass-fiber post (post in situ) at 2 years.
- Secondary Outcome Measures
Name Time Method 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)