NCT05213338

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 3, 2022

Completed
25 days until next milestone

First Posted

Study publicly available on registry

January 28, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

March 10, 2022

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2025

Completed
Last Updated

January 16, 2026

Status Verified

January 1, 2026

Enrollment Period

3.6 years

First QC Date

January 3, 2022

Last Update Submit

January 14, 2026

Conditions

Orthodontic Appliance Complication

Keywords

orthodontics

Outcome Measures

Primary Outcomes (1)

  • Treatment-time

    months

    through study completion, an average of 1 year

Secondary Outcomes (1)

  • Patient satisfaction

    through study completion, an average of 1 year

Study Arms (2)

wear-documentation

EXPERIMENTAL

Theramon

Device: Wear-documentation microchip

controls

NO INTERVENTION

No microchip

Interventions

Wear-documentation microchipDEVICE

Microchip embedded in the appliance

wear-documentation

Eligibility Criteria

Age10 Years - 15 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • orthodontic treatment with removable appliances planned

You may not qualify if:

  • non-compliance to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

City of Vantaa

Vantaa, 01600, Finland

Location

Study Officials

  • Heidi Arponen, PhD

    University of Helsinki

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator, DDS

Study Record Dates

First Submitted

January 3, 2022

First Posted

January 28, 2022

Study Start

March 10, 2022

Primary Completion

October 15, 2025

Study Completion

October 15, 2025

Last Updated

January 16, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Patient confidentiality prevents

Locations

FI(1)