Clinical trial NCT04422093: Monitoring System for the Wearing of Orthodontic Elastics
Official title: OrthoKontrol - System Zur Überwachung Der Tragedauer Von kieferorthopädischen Gummizügen
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Medical Device Complication
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2020-06-09
Enrollment: 0
Sex: ALL
Minimum age (years): 11
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with class II malocclusion in treatment with fixed appliances

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.

Eligibility criteria: 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

Primary outcomes:
measure: comfort of the device
timeFrame: 6 months
measure: Handling of the device
timeFrame: 6 months
Secondary outcomes:
measure: cooperation
timeFrame: 6 months
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University Center for Dental Medicine UZB
state: Basel Stadt
Study officials:
affiliation: University Center for Dental Medicine, Basel, Switzerland
name: Carlalberta Verna
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.