Prospective clinical study to evaluate the clinical performance of immediately placed Astra DS Prime Taper implants:A monocenter study
Recruiting
- Conditions
- K08.1Loss of teeth due to accident, extraction or local periodontal disease
- Registration Number
- DRKS00025234
- Lead Sponsor
- Goethe Universität Frankfurt, Zentrum der Zahn-, Mund- und Kieferheilkunde (Carolinum), Zahnärztliches Universitäts-Institut gGmbH, Poliklinik für Zahnärztliche Chirurgie und Implantologie
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 25
Inclusion Criteria
Males and females with an age of 18 to 69 years
- Planned single tooth replacement in maxilla (15-25 FDI) allowing the placement of a single implant
- Subject shall have a stable occlusal relationship
- Patient has been informed of the follow-up visits and is willing to return to the clinical center for these follow-up visits
- Subjects must have voluntarily signed the informed consent form before any study related action
Exclusion Criteria
- Systemic disease that would interfere with dental implant therapy (e.g. uncontrolled diabetes, osteoporosis)
- Bone metabolism disorders or medication (steroids, bisphosphonate)
-Pregnant or breastfeeding women
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Health of periimplant tissue measured as:<br>- Bleeding on probing (BOP)<br>- Mucosal recession (MR)<br>- probing depth (PD)<br>- Clinical attachment level (CAL))<br>- Volume changes of the periimplant soft tissue<br><br>Follow-up times: final prosthetic restoration, 6, 12 and 24 months after the final prosthetic restoration.
- Secondary Outcome Measures
Name Time Method impact of the treatment protocol on the periimplant soft and hart tissue