Ignite Creation Date:
2025-12-25 @ 1:22 AM
Ignite Modification Date:
2025-12-26 @ 1:35 AM
Study NCT ID:
NCT04422093
Status:
WITHDRAWN
Last Update Posted:
2025-04-13
First Post:
2020-06-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Monitoring System for the Wearing of Orthodontic Elastics
Sponsor:
University Hospital, Basel, Switzerland
Organization:
Study Overview
Official Title:
OrthoKontrol - System Zur Überwachung Der Tragedauer Von kieferorthopädischen Gummizügen
Status:
WITHDRAWN
Status Verified Date:
2025-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The device was found to be too bulky, and therefore we decided not to enrol any subjects.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
OK
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: