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

Class III Malocclusion Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04911400
• Other study ID #: X19-0365
• Status: Enrolling by invitation
• Phase: N/A
• Start date: July 22, 2020
• Est. completion date: January 2027

Study information

• Verified date: May 2023
• Source: Sydney Local Health District
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 42
• Est. completion date: January 2027
• Est. primary completion date: January 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years to 16 Years

Eligibility

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

Related Conditions & MeSH terms

• Class III Malocclusion
• Malocclusion
• Malocclusion, Angle Class III
• Prognathism

Intervention

Other:
• Upper-lower clear plastic retainers + Class III elastics
Addition of Class III elastics to clear plastic retainers
• Upper-lower clear plastic retainers
Upper-lower clear plastic retainers

Locations

Country	Name	City	State
Australia	Chatswood Orthodontics	Chatswood	New South Wales
Australia	Sydney Dental Hospital	Surry Hills	New South Wales

Sponsors (1)

Lead Sponsor	Collaborator
Sydney Local Health District

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in overjet of participants in the 2 study arms	Measurement of overjet	5 years
Secondary	Need for jaw surgery	Need for surgery assessed by a panel of orthodontists	5 years
Secondary	Difference in upper jaw position	The difference in SNA angle measured on cephalometric radiographs between groups	5 years
Secondary	Difference in lower jaw position	The difference in SNB angle measured on cephalometric radiographs between groups	5 years
Secondary	Difference in upper-lower jaw relationship	The difference in ANB angle measured on cephalometric radiographs between groups	5 years
Secondary	Difference in upper incisor angulation	The difference in upper incisor angle measured on cephalometric radiographs between groups	5 years
Secondary	Difference in lower incisor angulation	The difference in lower incisor angle measured on cephalometric radiographs between groups	5 years
Secondary	Compliance and ease of use of both retention regimens	Questionnaire on the frequency and ease of use of both retainer regimens will be used	5 years
Secondary	Effect of elastics on alignment retention	Little's irregularity index will be used to compare both groups	5 years
Secondary	Periodontal health, including recession around the incisors	Presence of gingival recession and prominence of lower incisors will be evaluated for both groups	5 years