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Active, not recruitingNCT04756843Updated Jul 8, 2025

Early Orthodontic Treatment of Dental Crowding

An interventional study of Quad-helix in Dental Crowding, sponsored by University of Helsinki. Active, not recruiting at 1 site in Finland. Open to participants aged 6 Years to 14 Years. Per ClinicalTrials.gov, last updated 2025-07-08.

Sponsored by University of Helsinki · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
6 Years to 14 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Dental Crowding

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03

In context

Crowding

88 studies on the registry are indexed under Crowding; 22 are open to participants now.

This study's planned enrollment of 60 is above the median of 36 across 74 interventional studies indexed under Crowding.

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Lead sponsor

University of Helsinki is the lead sponsor of 133 studies on the registry; 19 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Years to 14 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Dental developmental stage of mixed dentition
  • Crowding on both dental arches
  • Skeletal discrepancy not suspected

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    Early treatment

    Treatment started in the early mixed dentition phase

    Device: Quad-helix

  • Experimental
    Late treatment

    Treatment started in the late mixed dentition phase

    Device: Quad-helix

Interventions

  • DeviceQuad-helix

    Fixed orthodontic appliance

06

What researchers measure

Primary outcomes

  1. Treatment time

    Duration of treatment

    Time frame: Up to 36 months

Secondary outcomes

  1. Treatment burden

    Number of orthodontic appliances used

    Time frame: Up to 48 months

  2. Alignment of dental arches

    Occlusal end result of the treatment

    Time frame: up to 48 months

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 8, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04756843
Collaborators
City of Vantaa
Responsible party
Heidi Arponen (Principal investigator, University of Helsinki) — Principal investigator
First posted
Feb 16, 2021
Start date
Nov 18, 2022
Primary completion
Dec 2029 (estimated)
Completion
Jan 2030 (estimated)
Last update
Jul 8, 2025

Study contacts

Heidi Arponen, DDS
principal investigator · University of Helsinki

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.

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Discussion

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