Early Orthodontic Treatment of Dental Crowding | NCT04756843

Studies
Early Orthodontic Treatment of Dental Crowding

NCT04756843

Sponsor

University of Helsinki

Status

Active, not recruiting

Last Update Posted

Jul 8, 2025Actual

Enrollment

60Estimated

Phase

Not Applicable

Conditions

Dental Crowding

Interventions

Quad-helix

Countries

Finland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2025

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 18, 2022Actual

Primary Completion Date

Dec 2029Estimated

Completion Date

Jan 2030Estimated

First Submitted Date

Feb 8, 2021

First Submission Date that Met QC Criteria

Feb 11, 2021

First Posted Date

Feb 16, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 4, 2025

Last Update Posted Date

Jul 8, 2025Actual

Name	Class
City of Vantaa	OTHER_GOV

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Quad-helix	Device	Fixed orthodontic appliance	Early treatment Late treatment

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Years

Maximum Age

14 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Heidi Arponen, DDS	University of Helsinki	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Helsinki		Helsinki	Helsinki	FI-00014	Finland

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D013037	Spatial Behavior
D001519	Behavior