Wear-documentation and Orthodontic Appliance Compliance | NCT05213338

Studies
Wear-documentation and Orthodontic Appliance Compliance

NCT05213338

Sponsor

University of Helsinki

Status

Completed

Last Update Posted

Jan 16, 2026Actual

Enrollment

52Actual

Phase

Not Applicable

Conditions

Orthodontic Appliance Complication

Interventions

Wear-documentation microchip

Countries

Finland

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

Jan 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 10, 2022Actual

Primary Completion Date

Oct 15, 2025Actual

Completion Date

Oct 15, 2025Actual

First Submitted Date

Jan 3, 2022

First Submission Date that Met QC Criteria

Jan 15, 2022

First Posted Date

Jan 28, 2022Actual

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

Jan 14, 2026

Last Update Posted Date

Jan 16, 2026Actual

Name	Class
City of Vantaa	OTHER_GOV

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

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.

Detailed Description

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

52Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
wear-documentation	Experimental	Theramon	Device: Wear-documentation microchip
controls	No Intervention	No microchip

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Wear-documentation microchip	Device	Microchip embedded in the appliance	wear-documentation

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

orthodontic treatment with removable appliances planned

Exclusion Criteria:

non-compliance to participate in the study

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

10 Years

Maximum Age

15 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Heidi Arponen, PhD	University of Helsinki	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
City of Vantaa		Vantaa		01600	Finland

IPD Sharing Statement Module

Plan to Share IPD

Description

Patient confidentiality prevents

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided