Monitoring System for the Wearing of Orthodontic Elastics | NCT04422093

Studies
Monitoring System for the Wearing of Orthodontic Elastics

NCT04422093

Sponsor

University Hospital, Basel, Switzerland

Status

Withdrawn

Last Update Posted

Apr 13, 2025Actual

Enrollment

0Actual

Phase

Not provided

Conditions

Medical Device Complication

Interventions

OrthoKontrol

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2025

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

The device was found to be too bulky, and therefore we decided not to enrol any subjects.

Expanded Access Info

Start Date

Sep 15, 2021Actual

Primary Completion Date

Sep 15, 2023Estimated

Completion Date

Sep 15, 2023Estimated

First Submitted Date

Jun 4, 2020

First Submission Date that Met QC Criteria

Jun 4, 2020

First Posted Date

Jun 9, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 9, 2025

Last Update Posted Date

Apr 13, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
OrthoKontrol	Device	Fixing OrthoKontrol Sensor on multibracket appliance to measure cooperation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
cooperation	read on the sensors how long the patients followed the instructions	6 months

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

11 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

patients with class II malocclusion in treatment with fixed appliances

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Carlalberta Verna	University Center for Dental Medicine, Basel, Switzerland	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Center for Dental Medicine UZB		Basel	Canton of Basel-City	4056	Switzerland

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
20966997	Background	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.
28651764	Background	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.