NCT04756843

Brief 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
45mo left

Started Nov 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress49%
Nov 2022Jan 2030

First Submitted

Initial submission to the registry

February 8, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 16, 2021

Completed
1.8 years until next milestone

Study Start

First participant enrolled

November 18, 2022

Completed
7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2029

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2030

Last Updated

July 8, 2025

Status Verified

July 1, 2025

Enrollment Period

7 years

First QC Date

February 8, 2021

Last Update Submit

July 4, 2025

Conditions

Dental Crowding

Outcome Measures

Primary Outcomes (1)

  • Treatment time

    Duration of treatment

    Up to 36 months

Secondary Outcomes (2)

  • Treatment burden

    Up to 48 months

  • Alignment of dental arches

    up to 48 months

Study Arms (2)

Early treatment

EXPERIMENTAL

Treatment started in the early mixed dentition phase

Device: Quad-helix

Late treatment

EXPERIMENTAL

Treatment started in the late mixed dentition phase

Device: Quad-helix

Interventions

Quad-helixDEVICE

Fixed orthodontic appliance

Early treatmentLate treatment

Eligibility Criteria

Age6 Years - 14 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Helsinki

Helsinki, Helsinki, FI-00014, Finland

Location

MeSH Terms

Conditions

Crowding

Condition Hierarchy (Ancestors)

Spatial BehaviorBehavior

Study Officials

  • Heidi Arponen, DDS

    University of Helsinki

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

February 8, 2021

First Posted

February 16, 2021

Study Start

November 18, 2022

Primary Completion (Estimated)

December 1, 2029

Study Completion (Estimated)

January 1, 2030

Last Updated

July 8, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations

FI(1)