Monitoring System for the Wearing of Orthodontic Elastics

Medical Device Complication Clinical Trial

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Official title:

OrthoKontrol - System Zur Überwachung Der Tragedauer Von kieferorthopädischen Gummizügen

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04422093
• Other study ID #: OrthoKontrol
• Status: Recruiting
• Start date: September 15, 2021
• Est. completion date: September 15, 2023

Study information

• Verified date: December 2022
• Source: University Hospital, Basel, Switzerland
• Contact: Carlalberta Verna
• Phone: +410612672641
• Email: carlalberta.verna[@]unibas.ch
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 42
• Est. completion date: September 15, 2023
• Est. primary completion date: September 15, 2023
• Gender: All
• Age group: 11 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Medical Device Complication

Intervention

Device:
• OrthoKontrol
Fixing OrthoKontrol Sensor on multibracket appliance to measure cooperation

Locations

Country	Name	City	State
Switzerland	University Center for Dental Medicine UZB	Basel	Basel Stadt

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	comfort of the device	The wearing comfort for the patient is ok/not ok	6 months
Primary	Handling of the device	The handling for the therapist is ok/not ok	6 months
Secondary	cooperation	read on the sensors how long the patients followed the instructions	6 months