OrthoKontrol - System Zur Überwachung Der Tragedauer Von kieferorthopädischen Gummizügen
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Medical Device Complication
- Sponsor
- University Hospital, Basel, Switzerland
- Enrollment
- 42
- Locations
- 1
- Primary Endpoint
- comfort of the device
- Status
- Withdrawn
- Last Updated
- last year
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
comfort of the device
Time Frame: 6 months
The wearing comfort for the patient is ok/not ok
Handling of the device
Time Frame: 6 months
The handling for the therapist is ok/not ok
Secondary Outcomes
- cooperation(6 months)