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Active, not recruitingNCT04911400Updated May 8, 2026

Effects of Class III Elastics on Stability of Orthopaedic Class III Correction

An interventional study of Upper-lower clear plastic retainers + Class III elastics and Upper-lower clear plastic retainers in Class III Malocclusion and Underbite, sponsored by Sydney Local Health District. Active, not recruiting at 2 sites in Australia. Open to participants aged 12 Years to 16 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-08.

Sponsored by Sydney Local Health District · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 9 months after the study started (first participant enrolled Jul 2020, registered May 2021).
Phase
Not applicable
Study type
Interventional
Enrollment
42
Allocation
Randomized
Ages
12 Years to 16 Years
Sex
All
01

Study 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.

Read the detailed description

Over the years many types of appliances have been recommended for retaining Class III correction in growing children such as intermaxillary splints, class III activator, Frankel 3, Class III twin block, continued use of face-mask and chin-cup. However, currently none of these are in routine use and there is no evidence on the long term effectiveness of any retention protocol for class III correction.

One of the most commonly used retainers following orthodontic treatment is clear plastic retainers. There are no studies that investigated whether using class III elastics in combination with clear plastic retainers improves the stability of class III correction and reduces the need for later jaw surgery.

02

Conditions studied

  • Class III Malocclusion
  • Underbite

Keywords

  • Class III Malocclusion
  • Orthodontic retention
03

In context

Malocclusion, Angle Class III

57 studies on the registry are indexed under Malocclusion, Angle Class III; 11 are open to participants now.

This study's planned enrollment of 42 is above the median of 32 across 53 interventional studies indexed under Malocclusion, Angle Class III.

Browse Malocclusion, Angle Class III studies →

Lead sponsor

Sydney Local Health District is the lead sponsor of 5 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Years to 16 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • Congenital anomalies or craniofacial syndromes
  • Other orthodontic treatment
  • Medical history that effects growth
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
42 participants (estimated)

Study arms

  • Experimental
    Upper-lower clear plastic retainers + Class III elastics

    Upper-lower clear plastic retainers + Class III elastics

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

  • Active comparator
    Upper-lower clear plastic retainers

    Upper-lower clear plastic retainers

    Other: Upper-lower clear plastic retainers

Interventions

  • OtherUpper-lower clear plastic retainers + Class III elastics

    Addition of Class III elastics to clear plastic retainers

  • OtherUpper-lower clear plastic retainers

    Upper-lower clear plastic retainers

06

What researchers measure

Primary outcomes

  1. Difference in overjet of participants in the 2 study arms

    Measurement of overjet

    Time frame: 5 years

Secondary outcomes

  1. Need for jaw surgery

    Need for surgery assessed by a panel of orthodontists

    Time frame: 5 years

  2. Difference in upper jaw position

    The difference in SNA angle measured on cephalometric radiographs between groups

    Time frame: 5 years

  3. Difference in lower jaw position

    The difference in SNB angle measured on cephalometric radiographs between groups

    Time frame: 5 years

  4. Difference in upper-lower jaw relationship

    The difference in ANB angle measured on cephalometric radiographs between groups

    Time frame: 5 years

  5. Difference in upper incisor angulation

    The difference in upper incisor angle measured on cephalometric radiographs between groups

    Time frame: 5 years

  6. Difference in lower incisor angulation

    The difference in lower incisor angle measured on cephalometric radiographs between groups

    Time frame: 5 years

  7. Compliance and ease of use of both retention regimens

    Questionnaire on the frequency and ease of use of both retainer regimens will be used

    Time frame: 5 years

  8. Effect of elastics on alignment retention

    Little's irregularity index will be used to compare both groups

    Time frame: 5 years

  9. Periodontal health, including recession around the incisors

    Presence of gingival recession and prominence of lower incisors will be evaluated for both groups

    Time frame: 5 years

07

Study locations

2 sites
  • Chatswood Orthodontics
    Chatswood, New South Wales 2067, Australia
  • Sydney Dental Hospital
    Surry Hills, New South Wales 2010, Australia
08

References and documents

Publications

  • 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. PubMed 38597341 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 8, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04911400
Lead sponsor
Sydney Local Health District
Responsible party
Sponsor
First posted
Jun 3, 2021
Start date
Jul 22, 2020
Primary completion
Jan 2027 (estimated)
Completion
Dec 2027 (estimated)
Last update
May 8, 2026

Study contacts

Oyku Dalci, DDS, PhD
principal investigator · Sydney Local Health District, The University of Sydney

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.

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