NCT04911400

Brief Summary

The purpose of this study is to evaluate the effects of adding elastics to orthodontic retainers on the stability of class III correction and whether it reduces the need for jaw surgery.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
7mo left

Started Jul 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
enrolling by invitation

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 Progress90%
Jul 2020Jan 2027

Study Start

First participant enrolled

July 22, 2020

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

May 9, 2021

Completed
25 days until next milestone

First Posted

Study publicly available on registry

June 3, 2021

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2026

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2027

Expected
Last Updated

August 13, 2024

Status Verified

August 1, 2024

Enrollment Period

5.4 years

First QC Date

May 9, 2021

Last Update Submit

August 10, 2024

Conditions

Class III MalocclusionUnderbite

Keywords

Class III MalocclusionOrthodontic retention

Outcome Measures

Primary Outcomes (1)

  • Difference in overjet of participants in the 2 study arms

    Measurement of overjet

    5 years

Secondary Outcomes (9)

  • Need for jaw surgery

    5 years

  • Difference in upper jaw position

    5 years

  • Difference in lower jaw position

    5 years

  • Difference in upper-lower jaw relationship

    5 years

  • Difference in upper incisor angulation

    5 years

  • +4 more secondary outcomes

Study Arms (2)

Upper-lower clear plastic retainers + Class III elastics

EXPERIMENTAL

Upper-lower clear plastic retainers + Class III elastics

Other: Upper-lower clear plastic retainers + Class III elastics

Upper-lower clear plastic retainers

ACTIVE COMPARATOR

Upper-lower clear plastic retainers

Other: Upper-lower clear plastic retainers

Interventions

Upper-lower clear plastic retainers + Class III elasticsOTHER

Addition of Class III elastics to clear plastic retainers

Upper-lower clear plastic retainers + Class III elastics
Upper-lower clear plastic retainersOTHER

Upper-lower clear plastic retainers

Upper-lower clear plastic retainers

Eligibility Criteria

Age12 Years - 16 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Patients that completed their orthodontic treatment for the management of their skeletal class III with upper jaw retrusion that was treated with Class III orthopaedic appliances, followed by full fixed appliances.
  • No congenital anomalies or craniofacial syndromes
  • No other orthodontic treatment
  • No medical history that effects growth

You may not qualify if:

  • Congenital anomalies or craniofacial syndromes
  • Other orthodontic treatment
  • Medical history that effects growth

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Chatswood Orthodontics

Chatswood, New South Wales, 2067, Australia

Location

Sydney Dental Hospital

Surry Hills, New South Wales, 2010, Australia

Location

Related Publications (1)

  • Owens D, Watkinson S, Harrison JE, Turner S, Worthington HV. Orthodontic treatment for prominent lower front teeth (Class III malocclusion) in children. Cochrane Database Syst Rev. 2024 Apr 10;4(4):CD003451. doi: 10.1002/14651858.CD003451.pub3.

    PMID: 38597341DERIVED

MeSH Terms

Conditions

Malocclusion, Angle Class III

Condition Hierarchy (Ancestors)

MalocclusionTooth DiseasesStomatognathic Diseases

Study Officials

  • Oyku Dalci, DDS, PhD

    Sydney Local Health District, The University of Sydney

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 9, 2021

First Posted

June 3, 2021

Study Start

July 22, 2020

Primary Completion

January 1, 2026

Study Completion (Estimated)

January 1, 2027

Last Updated

August 13, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations

AU(2)