Study Stopped
The device was found to be too bulky, and therefore we decided not to enrol any subjects.
Monitoring System for the Wearing of Orthodontic Elastics
OK
OrthoKontrol - System Zur Überwachung Der Tragedauer Von kieferorthopädischen Gummizügen
1 other identifier
observational
N/A
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Sep 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 4, 2020
CompletedFirst Posted
Study publicly available on registry
June 9, 2020
CompletedStudy Start
First participant enrolled
September 15, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 15, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
September 15, 2023
CompletedApril 13, 2025
April 1, 2025
2 years
June 4, 2020
April 9, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
comfort of the device
The wearing comfort for the patient is ok/not ok
6 months
Handling of the device
The handling for the therapist is ok/not ok
6 months
Secondary Outcomes (1)
cooperation
6 months
Interventions
Fixing OrthoKontrol Sensor on multibracket appliance to measure cooperation
Eligibility Criteria
patients with class II malocclusion in treatment with fixed appliances
You may qualify if:
- Multibracket appliances (fixed braces) in both jaws
- Need for intermaxillary elastics on at least one side
- Minimum motor skills
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Center for Dental Medicine UZB
Basel, Canton of Basel-City, 4056, Switzerland
Related Publications (4)
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.
PMID: 20966997BACKGROUNDAl-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.
PMID: 28651764BACKGROUNDHuanca 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.
PMID: 31143922BACKGROUNDSchott 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.
PMID: 20963543BACKGROUND
Study Officials
- PRINCIPAL INVESTIGATOR
Carlalberta Verna
University Center for Dental Medicine, Basel, Switzerland
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 4, 2020
First Posted
June 9, 2020
Study Start
September 15, 2021
Primary Completion
September 15, 2023
Study Completion
September 15, 2023
Last Updated
April 13, 2025
Record last verified: 2025-04