K08.1
Conditions
Interventions
Group 1: Dynamic navigation of dental implant placement
Sponsors
Mininavident AG
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: • All ethnicities are considered • Partially dentate patients (mandible or maxilla) indicated for one or more dental implants with sufficient teeth in the arch to hold the tray (for marker fixation) registration. • Clinical situation suited for implantation as judged by the examining physician or principal investigator (satisfactory soft and hard tissue conditions and occlusion) • The patient must understand and sign the declaration of informed consent and be able to take part in the planned study program.
Exclusion criteria
Exclusion criteria: Patients with one or several of the following criteria cannot be included in the study: • Patients who are contraindicated generally for dental implant and/or study device • Patients who are not able to bear the risks of the procedure • Patients who are unable to understand and sign the declaration of informed consent • Patients currently taking part in another study for which the endpoints have not yet been reached • Patients suffering from a mental illness and/or who have been diagnosed with depression or are in a vulnerable population group (e.g., prisoners, serious drug addicts, persons with developmental problems) that hampers their ability to provide a declaration of informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| (1a) Effectiveness: Mean deviation (real vs. planned) of largest angle from z-axis. Note 1: 1-sided test, experimental hypothesis: mean deviation < “free hand” performance goal. Note 2: The “free hand” performance is 3.5°, “free hand” performance goal is 3.9° 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 is used as denominator. | — |
Secondary
| Measure | Time frame |
|---|---|
| (2) Mean deviation (real vs. planned) of deviation on apex in XY-direction (mesiodistal and oro-vestibular, 2D horizontal difference) Note 1: absolute values are used Note 2: 1-sided test, experimental hypothesis: mean deviation < “free hand” performance goal Note 3: the “free hand” performance is assumed as 2.3 mm, the “free hand” performance goal is 2.6 mm Notes 4, 5: see notes 3, 4 of primary performance endpoint (3) Mean deviation (real vs. planned) of deviation on basis (shoulder) in XY-direction (mesiodistal and oro-vestibular, 2D horizontal difference) Note 1: absolute values are used Note 2: 1-sided test, experimental hypothesis: mean deviation < “free hand” performance Note 3: the “free hand” performance is assumed as 1.2 mm, the “free hand” performance goal is 1.4 mm Notes 4, 5: see notes 3, 4 of primary performance 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
Germany
Contacts
Public ContactStefan Röhling
Oralchirurgie T1
Outcome results
None listed