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

Primary Purpose

Class III Malocclusion, Underbite

Status
Enrolling by invitation
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
Upper-lower clear plastic retainers + Class III elastics
Upper-lower clear plastic retainers
Sponsored by
Sydney Local Health District
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Class III Malocclusion focused on measuring Class III Malocclusion, Orthodontic retention

Eligibility Criteria

12 Years - 16 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Chatswood Orthodontics
  • Sydney Dental Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Upper-lower clear plastic retainers + Class III elastics

Upper-lower clear plastic retainers

Arm Description

Upper-lower clear plastic retainers + Class III elastics

Upper-lower clear plastic retainers

Outcomes

Primary Outcome Measures

Difference in overjet of participants in the 2 study arms
Measurement of overjet

Secondary Outcome Measures

Need for jaw surgery
Need for surgery assessed by a panel of orthodontists
Difference in upper jaw position
The difference in SNA angle measured on cephalometric radiographs between groups
Difference in lower jaw position
The difference in SNB angle measured on cephalometric radiographs between groups
Difference in upper-lower jaw relationship
The difference in ANB angle measured on cephalometric radiographs between groups
Difference in upper incisor angulation
The difference in upper incisor angle measured on cephalometric radiographs between groups
Difference in lower incisor angulation
The difference in lower incisor angle measured on cephalometric radiographs between groups
Compliance and ease of use of both retention regimens
Questionnaire on the frequency and ease of use of both retainer regimens will be used
Effect of elastics on alignment retention
Little's irregularity index will be used to compare both groups
Periodontal health, including recession around the incisors
Presence of gingival recession and prominence of lower incisors will be evaluated for both groups

Full Information

First Posted
May 9, 2021
Last Updated
May 22, 2023
Sponsor
Sydney Local Health District
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1. Study Identification

Unique Protocol Identification Number
NCT04911400
Brief Title
Effects of Class III Elastics on Stability of Orthopaedic Class III Correction
Official Title
Effects of Class III Elastics on Stability of Orthopaedic Class III Correction
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
July 22, 2020 (Actual)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
January 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sydney Local Health District

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Class III Malocclusion, Underbite
Keywords
Class III Malocclusion, Orthodontic retention

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
42 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Upper-lower clear plastic retainers + Class III elastics
Arm Type
Experimental
Arm Description
Upper-lower clear plastic retainers + Class III elastics
Arm Title
Upper-lower clear plastic retainers
Arm Type
Active Comparator
Arm Description
Upper-lower clear plastic retainers
Intervention Type
Other
Intervention Name(s)
Upper-lower clear plastic retainers + Class III elastics
Intervention Description
Addition of Class III elastics to clear plastic retainers
Intervention Type
Other
Intervention Name(s)
Upper-lower clear plastic retainers
Intervention Description
Upper-lower clear plastic retainers
Primary Outcome Measure Information:
Title
Difference in overjet of participants in the 2 study arms
Description
Measurement of overjet
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Need for jaw surgery
Description
Need for surgery assessed by a panel of orthodontists
Time Frame
5 years
Title
Difference in upper jaw position
Description
The difference in SNA angle measured on cephalometric radiographs between groups
Time Frame
5 years
Title
Difference in lower jaw position
Description
The difference in SNB angle measured on cephalometric radiographs between groups
Time Frame
5 years
Title
Difference in upper-lower jaw relationship
Description
The difference in ANB angle measured on cephalometric radiographs between groups
Time Frame
5 years
Title
Difference in upper incisor angulation
Description
The difference in upper incisor angle measured on cephalometric radiographs between groups
Time Frame
5 years
Title
Difference in lower incisor angulation
Description
The difference in lower incisor angle measured on cephalometric radiographs between groups
Time Frame
5 years
Title
Compliance and ease of use of both retention regimens
Description
Questionnaire on the frequency and ease of use of both retainer regimens will be used
Time Frame
5 years
Title
Effect of elastics on alignment retention
Description
Little's irregularity index will be used to compare both groups
Time Frame
5 years
Title
Periodontal health, including recession around the incisors
Description
Presence of gingival recession and prominence of lower incisors will be evaluated for both groups
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Oyku Dalci, DDS, PhD
Organizational Affiliation
Sydney Local Health District, The University of Sydney
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chatswood Orthodontics
City
Chatswood
State/Province
New South Wales
ZIP/Postal Code
2067
Country
Australia
Facility Name
Sydney Dental Hospital
City
Surry Hills
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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