CClinicalTrials.gg
Sign In
WithdrawnNCT04422093OKUpdated Apr 13, 2025

Monitoring System for the Wearing of Orthodontic Elastics

An observational study in Medical Device Complication, sponsored by University Hospital, Basel, Switzerland. Withdrawn at 1 site in Switzerland. Open to participants aged 11 Years and older. Per ClinicalTrials.gov, last updated 2025-04-13.

Sponsored by University Hospital, Basel, Switzerland · Observational

Why this study was withdrawn
The device was found to be too bulky, and therefore we decided not to enrol any subjects.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
0
Ages
11 Years and older
Sex
All
01

Study 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

Read the 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.

02

Conditions studied

  • Medical Device Complication
03

In context

Lead sponsor

University Hospital, Basel, Switzerland is the lead sponsor of 968 studies on the registry; 191 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
11 Years and older
Sexes eligible
All
Sampling method
Non-probability sample

Study population

patients with class II malocclusion in treatment with fixed appliances

Inclusion criteria

  • Multibracket appliances (fixed braces) in both jaws
  • Need for intermaxillary elastics on at least one side
  • Minimum motor skills

Exclusion criteria

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
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
0 participants (actual)
Patient registry
No

Interventions

  • DeviceOrthoKontrol

    Fixing OrthoKontrol Sensor on multibracket appliance to measure cooperation

06

What researchers measure

Primary outcomes

  1. comfort of the device

    The wearing comfort for the patient is ok/not ok

    Time frame: 6 months

  2. Handling of the device

    The handling for the therapist is ok/not ok

    Time frame: 6 months

Secondary outcomes

  1. cooperation

    read on the sensors how long the patients followed the instructions

    Time frame: 6 months

07

Study locations

1 site
  • University Center for Dental Medicine UZB
    Basel, Basel Stadt 4056, Switzerland
08

References and documents

Publications

  • Mizrahi E. Risk management in clinical practice. Part 7. Dento-legal aspects of orthodontic practice. Br Dent J. 2010 Oct 23;209(8):381-90. doi: 10.1038/sj.bdj.2010.926. PubMed 20966997 ↗
  • Al-Moghrabi D, Salazar FC, Pandis N, Fleming PS. Compliance with removable orthodontic appliances and adjuncts: A systematic review and meta-analysis. Am J Orthod Dentofacial Orthop. 2017 Jul;152(1):17-32. doi: 10.1016/j.ajodo.2017.03.019. PubMed 28651764 ↗
  • Huanca Ghislanzoni L, Ameur S, Antonarakis GS, Kiliaridis S. Headgear compliance as assessed by a temperature-sensitive recording device: a prospective clinical study. Eur J Orthod. 2019 Nov 15;41(6):641-645. doi: 10.1093/ejo/cjz036. PubMed 31143922 ↗
  • Schott TC, Goz G. Applicative characteristics of new microelectronic sensors Smart Retainer(R) and TheraMon(R) for measuring wear time. J Orofac Orthop. 2010 Sep;71(5):339-47. doi: 10.1007/s00056-010-1019-3. Epub 2010 Oct 21. English, German. PubMed 20963543 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 13, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04422093
Lead sponsor
University Hospital, Basel, Switzerland
Responsible party
Sponsor
First posted
Jun 9, 2020
Start date
Sep 15, 2021
Primary completion
Sep 15, 2023 (estimated)
Completion
Sep 15, 2023 (estimated)
Last update
Apr 13, 2025

Study contacts

Carlalberta Verna
principal investigator · University Center for Dental Medicine, Basel, Switzerland

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies from this sponsor

University Hospital, Basel, Switzerland

Start the discussion