Medical Device Complication
Conditions
Brief summary
The aim of the study is to validate a novel sensor intended to measure the wearing time of orthodontic elastics in patients with multibracket appliances. The newly developped sensor will be tested in 42 patients over a period of 6 months
Detailed description
Fixed multibracket appliances are used to correct tooth and jaw malocclusions. Usually, elastics are inserted between the upper and lower jaws to adjust the position of the jaws in relation to each other. The wearing time of the elastics determines the duration of the treatment and the quality of the treatment results. While micro-sensors are increasingly used for removable appliances to monitor patient compliance, there is still no such possibility for fixed appliances. This gap is to be closed with the planned 'OrthoKontrol' (intraoral mini-sensor). This is intended to measure and record the wearing time of the elastics.
Interventions
DEVICEOrthoKontrol
Fixing OrthoKontrol Sensor on multibracket appliance to measure cooperation
Sponsors
University Hospital, Basel, Switzerland
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
11 Years to No maximum
Inclusion criteria
* Multibracket appliances (fixed braces) in both jaws * Need for intermaxillary elastics on at least one side * Minimum motor skills
Exclusion criteria
* Patients with general diseases * Patients with inflammatory oral diseases * Patients with physical disabilities, which make it impossible to cooperate * Independent insertion of the elastics is not possible * Patients with impaired judgment Pregnant women
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| comfort of the device | 6 months | The wearing comfort for the patient is ok/not ok |
| Handling of the device | 6 months | The handling for the therapist is ok/not ok |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| cooperation | 6 months | read on the sensors how long the patients followed the instructions |
Countries
Switzerland
Outcome results
None listed