Evaluation of two different implant designs used for single tooth replacement and bridge reconstructions
- Conditions
- K08.1Loss of teeth due to accident, extraction or local periodontal disease
- Registration Number
- DRKS00007877
- Lead Sponsor
- Klinik für Zahnärztliche Prothetik
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 33
• The subjects should be more than 18 years old.
• The subject should be systemically healthy and have good compliance.
• The subject should be in need of an implant supported partial denture (bridge) or implant supported single tooth restorations in the posterior region.
• Alcohol or drug abuse.
• Psychiatric problems.
• Infectious disease, heart disease or disease of the circulatory system, metabolic disease, bone metabolism disorders, disturbance of the hematopoetic system, hematological disorders, wound healing disturbances, disorders of the endocrine system (i.e. uncontrolled diabetes), pregnancy, or local contraindications (i.e. tumors, ulcers etc) for dental surgery.
• The subject is not able to give her/his informed consent to participate.
• Not enough bone width or height for proper implant installation.
• The need of bone augmentation before implant installation to obtain a prosthetically correct implantation transversally.
• Any disorders in the planned implant area such as previous tumors, chronic bone disease, or previous irradiation.
• Severe bruxism.
Immediate insertion (e.g. placement of the implant immediately after extraction) will not be an exclusion criterion.
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The main hypothesis is to test whether or not the mean marginal bone resorption for SICmax oral implants is comparable to that of SICace oral implants after an observation period of 1, 3, and 5 years. Bone resorption will be evaluated with radiographical examinations which will be performed using a standardized method direct after implantation, after the delivery of the final prosthesis, as well as 1, 3 and 5 years postoperatively.
- Secondary Outcome Measures
Name Time Method The secondary objective is the evaluation of the Time-to-Failure-Event (implant loss). Here, the Event-Free-Survival is of interest.