Clinical trial NCT04911400: 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
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Class III Malocclusion
Underbite
Keywords: Class III Malocclusion
Orthodontic retention
Lead sponsor: Sydney Local Health District
Sponsor class: OTHER_GOV
First posted: 2021-06-03
Enrollment: 42
Sex: ALL
Minimum age (years): 12
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Difference in overjet of participants in the 2 study arms
timeFrame: 5 years
Secondary outcomes:
measure: Need for jaw surgery
timeFrame: 5 years
measure: Difference in upper jaw position
timeFrame: 5 years
measure: Difference in lower jaw position
timeFrame: 5 years
measure: Difference in upper-lower jaw relationship
timeFrame: 5 years
measure: Difference in upper incisor angulation
timeFrame: 5 years
measure: Difference in lower incisor angulation
timeFrame: 5 years
measure: Compliance and ease of use of both retention regimens
timeFrame: 5 years
measure: Effect of elastics on alignment retention
timeFrame: 5 years
measure: Periodontal health, including recession around the incisors
timeFrame: 5 years
Other outcomes:
Locations:
city: Chatswood
country: Australia
facility: Chatswood Orthodontics
state: New South Wales
city: Surry Hills
country: Australia
facility: Sydney Dental Hospital
state: New South Wales
Study officials:
affiliation: Sydney Local Health District, The University of Sydney
name: Oyku Dalci, DDS, PhD
role: PRINCIPAL_INVESTIGATOR
References: