Wear-documentation and Orthodontic Appliance Compliance

January 14, 2026 updated by: Heidi Arponen, University of Helsinki

Effect of Thermosensory Wear-documentation on Removable Orthodontic Appliance Compliance

This randomized controlled trial aims to evaluate whether thermosensory wear-time documentation improves patient compliance of removable orthodontic appliances treated in a public health care clinic. The patients are children and adolescents.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Qualitative subjective evaluation of appliance wear comfort and compliance is recorded, in addition to objective wear-time documentations.

Study Type

Interventional

Enrollment (Actual)

52

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Vantaa, Finland, 01600
        • City of Vantaa

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 15 years (Child)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • orthodontic treatment with removable appliances planned

Exclusion Criteria:

  • non-compliance to participate in the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: wear-documentation
Theramon
Device: Wear-documentation microchip
Microchip embedded in the appliance
No Intervention: controls
No microchip

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment-time
Time Frame: through study completion, an average of 1 year
months
through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient satisfaction
Time Frame: through study completion, an average of 1 year
qualitative self-evaluation
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Helsinki

Collaborators

City of Vantaa

Investigators

  • Principal Investigator: Heidi Arponen, PhD, University of Helsinki

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 10, 2022

Primary Completion (Actual)

October 15, 2025

Study Completion (Actual)

October 15, 2025

Study Registration Dates

First Submitted

January 3, 2022

First Submitted That Met QC Criteria

January 15, 2022

First Posted (Actual)

January 28, 2022

Study Record Updates

Last Update Posted (Estimated)

January 16, 2026

Last Update Submitted That Met QC Criteria

January 14, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • HUS/3333/2021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Patient confidentiality prevents

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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