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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04911400
Enrollment
42
Registered
2021-06-03
Start date
2020-07-22
Completion date
2027-12-01
Last updated
2026-05-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Class III Malocclusion, Underbite

Keywords

Class III Malocclusion, Orthodontic retention

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.

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.

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

Sponsors

Sydney Local Health District
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
12 Years to 16 Years
Healthy volunteers
Yes

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

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

Design outcomes

Primary

MeasureTime frameDescription
Difference in overjet of participants in the 2 study arms5 yearsMeasurement of overjet

Secondary

MeasureTime frameDescription
Need for jaw surgery5 yearsNeed for surgery assessed by a panel of orthodontists
Difference in upper jaw position5 yearsThe difference in SNA angle measured on cephalometric radiographs between groups
Difference in lower jaw position5 yearsThe difference in SNB angle measured on cephalometric radiographs between groups
Difference in upper-lower jaw relationship5 yearsThe difference in ANB angle measured on cephalometric radiographs between groups
Difference in upper incisor angulation5 yearsThe difference in upper incisor angle measured on cephalometric radiographs between groups
Difference in lower incisor angulation5 yearsThe difference in lower incisor angle measured on cephalometric radiographs between groups
Compliance and ease of use of both retention regimens5 yearsQuestionnaire on the frequency and ease of use of both retainer regimens will be used
Effect of elastics on alignment retention5 yearsLittle's irregularity index will be used to compare both groups
Periodontal health, including recession around the incisors5 yearsPresence of gingival recession and prominence of lower incisors will be evaluated for both groups

Countries

Australia

Contacts

PRINCIPAL_INVESTIGATOROyku Dalci, DDS, PhD

Sydney Local Health District, The University of Sydney

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 9, 2026