Fixed versus removable implant-supported reconstructions in the edentulous jaw: a randomized controlled clinical study.
- Conditions
- K08.1Loss of teeth due to accident, extraction or local periodontal disease
- Registration Number
- DRKS00021083
- Lead Sponsor
- niversität Zürich, Zentrum für Zahnmedizin, Klinik für Rekonstruktive Zahnmedizin
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 32
• Signed informed consent form
• Male and female patients with at least 18 years of age
• At least one edentulous jaw in need of a new reconstruction
• Fixed reconstruction feasible / advisable (to be evaluated at Visit 2: secondary inclusion criterion)
• Presence of an adequate quantity of bone for the placement of dental implants in the position of the canines and lateral incisors (implant dimension: 4.2x 8mm) and in the posterior area (4.2 x 6mm) (smaller dehiscence or fenestration defects are allowed) (to be evaluated at Visit 4: tertiary inclusion criterion)
• Known or suspected non-compliance, drug or alcohol abuse
• Active periodontal disease
• Medical history in which any elective oral surgical intervention would be contraindicated
• Heavy smoking (>10 cigarettes/day)
• Women who are pregnant or breast feeding at date of inclusion
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary outcome of the study is the incidence of technical complications occurring 5 years after baseline.
- Secondary Outcome Measures
Name Time Method Secondary endpoints will be assessed at each follow-up visit (6 months, 1 year, 3 years and 5 years after baseline).<br>- Biological complications (using clinical measurements)<br>- Marginal bone level (using x-rays)<br>- Patient reported outcomes (PROMs)<br>- Maintenance of the prostheses or need for further interventions