Orthodontic Appliance ComplicationNCT05213338
Wear-documentation and Orthodontic Appliance Compliance
A study testing Wear-documentation microchip in people with Orthodontic Appliance Complication, run by University of Helsinki at 1 site in Finland.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Orthodontic Appliance Complication
- What is being tested?
- Wear-documentation microchip
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteFinland
- Study dates
- 10 Mar 2022to 15 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- orthodontic treatment with removable appliances planned
Who cannot join
- non-compliance to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the detailed description
Qualitative subjective evaluation of appliance wear comfort and compliance is recorded, in addition to objective wear-time documentations.
- Conditions
- Orthodontic Appliance Complication
- Being tested
- Wear-documentation microchip
- Keywords
- orthodontics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wear-documentation microchipDevice
Microchip embedded in the appliance
| Study group | Role | What they receive |
|---|---|---|
| wear-documentation | Experimental | Theramon Receives: Device: Wear-documentation microchip |
| controls | No intervention | No microchip |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment-time
months
Measured: through study completion, an average of 1 year
Secondary outcomes (1)
Patient satisfaction
qualitative self-evaluation
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2022
- Study start10 Mar 2022
- Primary completion15 Oct 2025
- Study completion15 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Orthodontic Appliance ComplicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Helsinki
- Sponsor type
- University, hospital or other
- Collaborators
- City of Vantaa
- Responsible party
- Principal investigator, Heidi Arponen, University of Helsinki
- Investigators
- Heidi Arponen, PhD, Principal investigator, University of Helsinki
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05213338
- Sponsor's protocol ID
- HUS/3333/2021
- Status last verified
- Jan 2026
- First submitted
- 3 Jan 2022
- Last updated
- 16 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Patient confidentiality prevents
Publications
Arponen H, Aberg T. Wear-time monitoring in functional orthodontic appliances does not enhance patient satisfaction and is not associated with improved treatment duration or occlusal outcomes: A randomized controlled trial. J World Fed Orthod. 2026 Sep 15:S2212-4438(26)00057-3. doi: 10.1016/j.ejwf.2026.08.002. Online ahead of print.
PubMed 42744723
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Thermosensory Wear-documentation on Removable Orthodontic Appliance Compliance
- ClinicalTrials.gov ID
- NCT05213338
- Acronym / sponsor ID
- HUS/3333/2021
- Conditions
- Orthodontic Appliance Complication
- Keywords
- orthodontics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- University of HelsinkiUniversity, hospital or other
- Collaborators
- City of Vantaa
- Study start
- 10 Mar 2022 (actual)
- Primary completion
- 15 Oct 2025 (actual)
- Study completion
- 15 Oct 2025 (actual)
- First posted
- 28 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| wear-documentation | Experimental | Device: Wear-documentation microchipTheramon |
| controls | No intervention | –No microchip |
Who may qualify
- Ages
- 10 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- orthodontic treatment with removable appliances planned
Key exclusion criteria (1 listed)
- non-compliance to participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Wear-documentation microchipMicrochip embedded in the appliance | Device | wear-documentation |
Primary outcome
Treatment-time
Time frame: through study completion, an average of 1 year
months
1 secondary outcome
Patient satisfaction
Time frame: through study completion, an average of 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2026.
- Derived from this study: PubMed 42744723Arponen H, Aberg T. Wear-time monitoring in functional orthodontic appliances does not enhance patient satisfaction and is not associated with improved treatment duration or occlusal outcomes: A randomized controlled trial. J World Fed Orthod. 2026 Sep 15:S2212-4438(26)00057-3. doi: 10.1016/j.ejwf.2026.08.002. Online ahead of print.
- Individual participant dataSharing planned: No. Patient confidentiality prevents
Related trials for Orthodontic Appliance Complication
Recruiting
Bacterial Diversity Study Using 16S rRNA Sequencing of Periodontal Samples From Patients With Orthodontic Retainers
Fixed Orthodontic Retainer, Orthodontic Appliances, Removable
Recruiting
Comparison of MI Paste Plus and Resin Infiltration in White Spot Lesions Following Orthodontic Treatment
White Spot Lesions, Orthodontic Appliance Complication
Recruiting
The Effect of Intraoral Transcutaneous Electrical Nerve Stimulation in Orthodontics Pain
Orthodontic Appliance, Pain
Not yet recruiting
Comparison of a 3-step Bonding System (Transbond™ XT) and a 2-step System (GC Ortho Connect™) on Demineralization Around Maxillary Orthodontic Brackets
Tooth Demineralization, White Spot Lesion
Recruiting
Microbial Adherence, Surface Roughness, Effectiveness and Impact on Patients Between Conventional and 3D Printed Twin Block Appliances
Orthodontic Appliances, Removable, Orthodontic Appliance Complication
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Heidi Arponen, PhD principal investigator
University of Helsinki
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wear-documentation microchip in people with Orthodontic Appliance Complication, run by University of Helsinki at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment-time (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05213338, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2026.