Monitoring System for the Wearing of Orthodontic Elastics

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2021-09-15

Study Completion Date

2023-09-15

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Medical Device Complication

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Interventions

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OrthoKontrol

Fixing OrthoKontrol Sensor on multibracket appliance to measure cooperation

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

11 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No