Early Orthodontic Treatment of Dental Crowding

July 4, 2025 updated by: Heidi Arponen, University of Helsinki

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Helsinki, Finland, FI-00014
        • University of Helsinki

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 14 years (Child)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Early treatment
Treatment started in the early mixed dentition phase
Device: Quad-helix
Fixed orthodontic appliance
Experimental: Late treatment
Treatment started in the late mixed dentition phase
Device: Quad-helix
Fixed orthodontic appliance

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment time
Time Frame: Up to 36 months
Duration of treatment
Up to 36 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment burden
Time Frame: Up to 48 months
Number of orthodontic appliances used
Up to 48 months
Alignment of dental arches
Time Frame: up to 48 months
Occlusal end result of the treatment
up to 48 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Helsinki

Collaborators

City of Vantaa

Investigators

  • Principal Investigator: Heidi Arponen, DDS, University of Helsinki

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 18, 2022

Primary Completion (Estimated)

December 1, 2029

Study Completion (Estimated)

January 1, 2030

Study Registration Dates

First Submitted

February 8, 2021

First Submitted That Met QC Criteria

February 11, 2021

First Posted (Actual)

February 16, 2021

Study Record Updates

Last Update Posted (Estimated)

July 8, 2025

Last Update Submitted That Met QC Criteria

July 4, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HUS/3102/2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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