Tooth loss
Conditions
Interventions
Straumann® Falcon 
Sponsors
Institut Straumann AG
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Patients with the following criteria can be included in the study:· The patient of either sex must be =18 years old.· Partially edentulous patients requiring a dental implant, with a suitable clinical situation as judged by the examining physician or principal investigator (e.g., satisfactory soft and hard tissue conditions and occlusion).· The patient must understand and sign the informed consent form and be able to participate in the planned study program.
Exclusion criteria
Exclusion criteria: Exclusion criteriaPatients with one or several of the following criteria cannot be included in the study:Fully edentulous patients.Patients who do not have a minimum of 3 adjacent teeth for accurate positioning of the digital tray, and another tooth for the accuracy check (distant of a minimum of 30 mm from the marker position).Patient where dental implant treatment is contraindicated, as referred in the dental implant instructions for use.Matching any of the contraindications listed in the Instruction for use of Straumann® Falcon.Pregnant women and women planning to get pregnant during the study conduct.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1a) Effectiveness· Mean deviation (real vs. planned) of the angle from Z-axis.Note 1: 1-sided test, alpha level 0.025, experimental hypothesis: mean deviation < free hand NI criterion.Note 2: Based on square root transformed values [unit sqrt(°)], the free hand performance is 2.27, free hand performance goal is 2.34. The mean deviation on original scale will be estimated via back-transformation of mean of transformed values. On this scale, the free hand performance is 5.2°, free hand performance goal is 5.5°.Note 3: Since angles (and other distance measures) are right skewed, the mean deviation will be estimated via back transformation of mean of transformed values.Note 4: square root transformation will be applied, but final decision on transformation will be made in statistical analysis plan.(1b) Safety· Proportion of patients with device related SAE (SADE) until discharge.Note: the denominator is the number of patients in ITT analysis set. In addition, the number of patients in mITT isused as denominator. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary parameters to be measured in this study include the following:(2) Mean deviation (real vs. planned) of deviation on the apex in XY-direction (mesiodistal and bucco-oral, 2D horizontal difference).Note 1: absolute values are used.Note 2: 1-sided test, alpha level 0.025, experimental hypothesis: mean deviation < free hand performance goal.Note 3: based on square root transformed values [unit sqrt(mm)], the free hand performance is assumed as 1.42, the free hand performance goal is 1.48.Notes 4, 5: see notes 3, 4 of primary effectiveness endpoint.(3) Mean deviation (real vs. planned) of deviation on the basis (shoulder) in XY-direction (mesiodistal and bucco-oral, 2D horizontal difference).Note 1: absolute values are used.Note 2: 1-sided test, alpha level 0.025, experimental hypothesis: mean deviation < free hand performance.Note 3: based on square root transformed values [unit sqrt(mm)], the free hand performance is assumed as 1.07, the free hand performance goal is 1.13.The mean deviation on original scale will be estimated via back-transformation of mean of transformed values. On this scale, the free hand performance is 1.2 mm, free hand performance goal is 1.3 mm.Notes 4, 5: see notes 3, 4 of primary effectiveness endpoint.Note 6: this endpoint is relevant for sample size estimation, because the difference of deviation between investigated method and free hand performance is expected to be the smallest. | — |
Countries
Belgium, Italy, Netherlands, Switzerland
Contacts
Public ContactM Wojcik
Institut Straumann AG
Outcome results
None listed