Back to results

Early Orthodontic Treatment of Dental Crowding

Primary Purpose

Dental Crowding

Status

Recruiting

Phase

Not Applicable

Locations

Finland

Study Type

Interventional

Intervention

Quad-helix

About this trial

This is an interventional treatment trial for Dental Crowding

Eligibility Criteria

6 Years - 14 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University of HelsinkiRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Early treatment

Late treatment

Arm Description

Treatment started in the early mixed dentition phase

Treatment started in the late mixed dentition phase

Outcomes

Primary Outcome Measures

Treatment time

Duration of treatment

Secondary Outcome Measures

Treatment burden

Number of orthodontic appliances used

Alignment of dental arches

Occlusal end result of the treatment

Full Information

NCT ID

NCT04756843

First Posted

February 8, 2021

Last Updated

February 14, 2023

Sponsor

University of Helsinki

Collaborators

City of Vantaa

1. Study Identification

Unique Protocol Identification Number

NCT04756843

Brief Title

Early Orthodontic Treatment of Dental Crowding

Official Title

Early Versus Late Orthodontic Treatment of Dental Crowding - a Randomised Controlled Trial

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Recruiting

Study Start Date

November 18, 2022 (Actual)

Primary Completion Date

December 2029 (Anticipated)

Study Completion Date

January 2030 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Helsinki

Collaborators

City of Vantaa

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dental Crowding

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Early treatment

Arm Type

Experimental

Arm Description

Treatment started in the early mixed dentition phase

Arm Title

Late treatment

Arm Type

Experimental

Arm Description

Treatment started in the late mixed dentition phase

Intervention Type

Device

Intervention Name(s)

Quad-helix

Intervention Description

Fixed orthodontic appliance

Primary Outcome Measure Information:

Title

Treatment time

Description

Duration of treatment

Time Frame

Up to 36 months

Secondary Outcome Measure Information:

Title

Treatment burden

Description

Number of orthodontic appliances used

Time Frame

Up to 48 months

Title

Alignment of dental arches

Description

Occlusal end result of the treatment

Time Frame

up to 48 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Years

Maximum Age & Unit of Time

14 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Heidi Arponen, DDS

Phone

358 9 4711

heidi.arponen@helsinki.fi

First Name & Middle Initial & Last Name or Official Title & Degree

Thomas Åberg, DDS

thomas.aberg@sipoo.fi

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Heidi Arponen, DDS

Organizational Affiliation

University of Helsinki

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Helsinki

City

Helsinki

ZIP/Postal Code

FI-00014

Country

Finland

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Heidi Arponen, DDS

heidi.arponen@helsinki.fi

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Early Orthodontic Treatment of Dental Crowding

We'll reach out to this number within 24 hrs