NCT01649531
Active, not recruiting
Not Applicable
Two Implants Versus One Implant With a Cantilever - a Randomized Controlled Clinical Trial
ConditionsDental Implants
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Dental Implants
- Sponsor
- University of Zurich
- Enrollment
- 36
- Locations
- 1
- Primary Endpoint
- radiographic bone level
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
The aim of the present study is to test whether there is a difference in the marginal bone level change between implants with and without cantilevers.
Investigators
Eligibility Criteria
Inclusion Criteria
- •male and female patients 18 years to 80 years of age
- •no general medical condition which represents a contraindication to implant treatment
- •two adjacent missing teeth in the maxilla or mandible in positions of premolars and molars
- •at least one tooth present adjacent to the edentulous space
- •indication for implant treatment is given
- •at least 8 mm of vertical bone height in the mandible allowing for the placement of a 6 mm implant (2 mm safety distance to inferior alveolar nerve)
- •at least 4 mm of vertical bone height in the maxilla
- •signed informed consent after being informed
Exclusion Criteria
- •smoking of more than 15 cigarettes a day (clinical studies show an increased failure rate of implants in heavy smokers)
- •poor oral hygiene after hygienic phase (Plaque Index over 30 %)
- •active periodontal disease
- •pregnancy or breastfeeding at date of inclusion
Outcomes
Primary Outcomes
radiographic bone level
Time Frame: 5 years
The primary endpoint of the study is the radiographic bone level 5 years after insertion.The bone level represents an indicator of the osseointegration and biological success of the implant.
Secondary Outcomes
- Radiographic bone level(1, 3, 7, 10 years)
- rate of technical complication(1, 3, 5, 7, 10 years)
- rate of biological complications(1, 3, 5, 7, 10 years)
- Soft tissue changes(1, 3, 5, 7, 10 years)
- Implant survival and success(1, 3, 5, 7, 10 years)
- Patient morbidity(1, 3, 5, 7, 10 years)
Study Sites (1)
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