Dental CrowdingNCT04756843
Early Orthodontic Treatment of Dental Crowding
A study testing Quad-helix in people with Dental Crowding, run by University of Helsinki at 1 site in Finland.
Trial summary
Aim of the study is to compare treatment duration and effects of orthodontic treatment of dental crowding between treatments started at different stages of mixed dentition phase. The randomized controlled trial study will be conducted in a public health care center. Read more about this study
- Who is it for?
- Ages 6 to 14 years
- Conditions the study is for
- Dental Crowding
- What is being tested?
- Quad-helix
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFinland
- Study dates
- 18 Nov 2022to Jan 2030
- Phase
- Interventional
- 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 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Dental developmental stage of mixed dentition
- Crowding on both dental arches
- Skeletal discrepancy not suspected
Who cannot join
- National criteria for publicly funded treatment not met by the severity of the malocclusion
- Other malocclusions
- Angle Class III relationship of the molars
- Malocclusion related to a syndrome
- Non-compliance to orthodontic treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Early Versus Late Orthodontic Treatment of Dental Crowding - a Randomised Controlled Trial
Aim of the study is to compare treatment duration and effects of orthodontic treatment of dental crowding between treatments started at different stages of mixed dentition phase. The randomized controlled trial study will be conducted in a public health care center.
- Conditions
- Dental Crowding
- Being tested
- Quad-helix
- Medical subject headings
- Crowding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quad-helixDevice
Fixed orthodontic appliance
| Study group | Role | What they receive |
|---|---|---|
| Early treatment | Experimental | Treatment started in the early mixed dentition phase Receives: Device: Quad-helix |
| Late treatment | Experimental | Treatment started in the late mixed dentition phase Receives: Device: Quad-helix |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment time
Duration of treatment
Measured: Up to 36 months
Secondary outcomes (2)
Treatment burden
Number of orthodontic appliances used
Measured: Up to 48 months
Alignment of dental arches
Occlusal end result of the treatment
Measured: up to 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2021
- Study start18 Nov 2022
- Primary completionDec 2029 (estimated)
- Study completionJan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental CrowdingStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
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, DDS, Principal investigator, University of Helsinki
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04756843
- Sponsor's protocol ID
- HUS/3102/2020
- Status last verified
- Jul 2025
- First submitted
- 8 Feb 2021
- Last updated
- 8 Jul 2025
- 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 8 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Versus Late Orthodontic Treatment of Dental Crowding - a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT04756843
- Acronym / sponsor ID
- HUS/3102/2020
- Conditions
- Dental Crowding
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of HelsinkiUniversity, hospital or other
- Collaborators
- City of Vantaa
- Study start
- 18 Nov 2022 (actual)
- Primary completion
- Dec 2029 (estimated)
- Study completion
- Jan 2030 (estimated)
- First posted
- 16 Feb 2021 (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.
Aim of the study is to compare treatment duration and effects of orthodontic treatment of dental crowding between treatments started at different stages of mixed dentition phase. The randomized controlled trial study will be conducted in a public health care center.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early treatment | Experimental | Device: Quad-helixTreatment started in the early mixed dentition phase |
| Late treatment | Experimental | Device: Quad-helixTreatment started in the late mixed dentition phase |
Who may qualify
- Ages
- 6 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Dental developmental stage of mixed dentition
- Crowding on both dental arches
- Skeletal discrepancy not suspected
Key exclusion criteria (5 listed)
- National criteria for publicly funded treatment not met by the severity of the malocclusion
- Other malocclusions
- Angle Class III relationship of the molars
- Malocclusion related to a syndrome
- Non-compliance to orthodontic treatment
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 |
|---|---|---|
| Quad-helixFixed orthodontic appliance | Device | Early treatment, Late treatment |
Primary outcome
Treatment time
Time frame: Up to 36 months
Duration of treatment
2 secondary outcomes
Treatment burden
Time frame: Up to 48 months
Alignment of dental arches
Time frame: up to 48 months
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 8 Jul 2025.
- Individual participant dataSharing planned: No
Related trials for Dental Crowding
Active, not recruitingObservational study
Accuracy and Time Efficiency of AI Versus Manual Segmentation in Adult Crowding Using Aligner Software
Dental Crowding
Active, not recruiting
Treatment of the Mandibular Dental Crowding With and Without Corticotomy Surgery
Dental Research, Orthodontics
RecruitingObservational study
Exploration of the Utility of Dental-dedicated MRI for Dentistry
Dental Crowding, Dental Occlusion, Traumatic
Not yet recruiting
Orthodontic Treatment Outcomes of Self Ligating System Compared to Clear Aligner System
Angle Class I Maloclussion, Dental Crowding
RecruitingObservational study
Validity of Ashley Howe's Analysis for the Prediction of the Extraction Treatment Decision in Orthodontic Patients at the Permanent Dentition Stage
Dental Crowding
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, DDS 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 Quad-helix in people with Dental Crowding, 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 3 inclusion and 5 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 8 Jul 2025. 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?
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 time (time frame: Up to 36 months). 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 8 Jul 2025.