MalocclusionNCT06464003
Orthodontic Screening in Public Healthcare
An observational study of Malocclusion and Compliance, Patient, run by University of Helsinki at 2 sites in Finland.
Trial summary
The aim of the study is to examine orthodontic screening practises in public health care. Read more about this study
- Who is it for?
- Ages 6 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Malocclusion, Compliance, Patient
- What is being tested?
- Questionnaire
- How many people
- 350 participants
- Where
- 2 sitesFinland
- Study dates
- 6 Jun 2024to 6 Jun 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 6 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Unselected population sample study
Who may be able to join
- residence in the wellbeing services county catchment area
- willingness to participate in the study
Who cannot join
- Age under 6 years or over 16 years
- insufficient language skills to be able to understand the questionnaire
Trial locations and contacts
2 sites in 1 country.
Finland2 sites
University of Helsinki
Helsinki, FI-00014
Vantaa and Kerava wellbeing services county
Vantaa, 01030
About this study
Official title: Orthodontic Screening and Treatment Need in Public Health Care
The aim of the study is to examine orthodontic screening practises in public health care.
Read the detailed description
The study aims to assess repeatability of malocclusion evaluation in orthodontic treatment need screening in a publicly funded clinic. The objective treatment need is compared with subjective need for orthodontic treatment.
- Conditions
- Malocclusion, Compliance, Patient
- Being tested
- Questionnaire
- Medical subject headings
- Malocclusion, Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
Malocclusion impact questionnaire
| Study group | Role | What they receive |
|---|---|---|
| Treatment need | Individuals with objective treatment need Receives: Other: Questionnaire | |
| No treatment need | Individuals with no objectively determined treatment need Receives: Other: Questionnaire | |
| Controls | Random sample of individuals Receives: Other: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment need
Orthodontic treatment need
Measured: Baseline
Secondary outcomes (1)
Subjective evaluation
A questionnaire enquiring subjective evaluation of the treatment need and impact of malocclusion on oral heath related quality of life
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2024
- Study start6 Jun 2024
- Primary completion6 Jun 2026 (estimated)
- Study completion6 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalocclusionStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Helsinki
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Heidi Arponen, University of Helsinki
- Investigators
- Heidi Arponen, Study director, University of Helsinki
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06464003
- Sponsor's protocol ID
- UHelsinki
- Status last verified
- Jun 2026
- First submitted
- 6 Jun 2024
- Last updated
- 17 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Orthodontic Screening and Treatment Need in Public Health Care
- ClinicalTrials.gov ID
- NCT06464003
- Acronym / sponsor ID
- UHelsinki
- Conditions
- Malocclusion, Compliance, Patient
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- University of HelsinkiUniversity, hospital or other
- Study start
- 6 Jun 2024 (actual)
- Primary completion
- 6 Jun 2026 (estimated)
- Study completion
- 6 Jun 2026 (estimated)
- First posted
- 18 Jun 2024 (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.
The aim of the study is to examine orthodontic screening practises in public health care.
Detailed description
The study aims to assess repeatability of malocclusion evaluation in orthodontic treatment need screening in a publicly funded clinic. The objective treatment need is compared with subjective need for orthodontic treatment.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Treatment need | – | Other: QuestionnaireIndividuals with objective treatment need |
| No treatment need | – | Other: QuestionnaireIndividuals with no objectively determined treatment need |
| Controls | – | Other: QuestionnaireRandom sample of individuals |
Who may qualify
- Ages
- 6 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Unselected population sample study
Key inclusion criteria (2 listed)
- residence in the wellbeing services county catchment area
- willingness to participate in the study
Key exclusion criteria (2 listed)
- Age under 6 years or over 16 years
- insufficient language skills to be able to understand the questionnaire
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 |
|---|---|---|
| QuestionnaireMalocclusion impact questionnaire | Other | Controls, No treatment need, Treatment need |
Primary outcome
Treatment need
Time frame: Baseline
Orthodontic treatment need
1 secondary outcome
Subjective evaluation
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2026.
- Individual participant dataSharing planned: No
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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 study director
University of Helsinki
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Malocclusion and Compliance, Patient, run by University of Helsinki at 2 sites 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 2 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
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 need (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Jun 2026.