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

NCT ID: NCT04911400

Last Updated: 2024-08-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-22

Study Completion Date

2027-01-31

Brief Summary

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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

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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.

Conditions

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Class III Malocclusion Underbite

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Upper-lower clear plastic retainers + Class III elastics

Upper-lower clear plastic retainers + Class III elastics

Group Type EXPERIMENTAL

Upper-lower clear plastic retainers + Class III elastics

Intervention Type OTHER

Addition of Class III elastics to clear plastic retainers

Upper-lower clear plastic retainers

Upper-lower clear plastic retainers

Group Type ACTIVE_COMPARATOR

Upper-lower clear plastic retainers

Intervention Type OTHER

Upper-lower clear plastic retainers

Interventions

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Upper-lower clear plastic retainers + Class III elastics

Addition of Class III elastics to clear plastic retainers

Intervention Type OTHER

Upper-lower clear plastic retainers

Upper-lower clear plastic retainers

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

12 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Sydney Local Health District

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Oyku Dalci, DDS, PhD

Role: PRINCIPAL_INVESTIGATOR

Sydney Local Health District, The University of Sydney

Locations

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Chatswood Orthodontics

Chatswood, New South Wales, Australia

Site Status

Sydney Dental Hospital

Surry Hills, New South Wales, Australia

Site Status

Countries

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Australia

References

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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.

Reference Type DERIVED
PMID: 38597341 (View on PubMed)

Other Identifiers

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X19-0365

Identifier Type: -

Identifier Source: org_study_id

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