Wear-documentation and Orthodontic Appliance Compliance

NCT ID: NCT05213338

Last Updated: 2026-01-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-10

Study Completion Date

2025-10-15

Brief Summary

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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

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

Conditions

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Orthodontic Appliance Complication

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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wear-documentation

Theramon

Group Type EXPERIMENTAL

Wear-documentation microchip

Intervention Type DEVICE

Microchip embedded in the appliance

controls

No microchip

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Wear-documentation microchip

Microchip embedded in the appliance

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* orthodontic treatment with removable appliances planned

Exclusion Criteria

* non-compliance to participate in the study
Minimum Eligible Age

10 Years

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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City of Vantaa

OTHER_GOV

Sponsor Role collaborator

University of Helsinki

OTHER

Sponsor Role lead

Responsible Party

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Heidi Arponen

Principal investigator, DDS

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Heidi Arponen, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Helsinki

Locations

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City of Vantaa

Vantaa, , Finland

Site Status

Countries

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Finland

Other Identifiers

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HUS/3333/2021

Identifier Type: -

Identifier Source: org_study_id

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