Monitoring System for the Wearing of Orthodontic Elastics

Withdrawn

• Conditions: Medical Device Complication

• Registration Number: NCT04422093
• Lead Sponsor: University Hospital, Basel, Switzerland

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.

Study Timeline

• Study First Submitted: 2020-06-04
• Study First Submitted QC: 2020-06-04
• Study First Posted: 2020-06-09
• Study Start: 2021-09-15
• Primary Completion: 2023-09-15
• Study Completion: 2023-09-15
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-09
• Last Update Posted: 2025-04-13

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: 42

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
cooperation	6 months	read on the sensors how long the patients followed the instructions

Trial Locations

Locations (1)

University Center for Dental Medicine UZB; 🇨🇭 Basel, Basel Stadt, Switzerland