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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04911400




Registration number
NCT04911400
Ethics application status
Date submitted
9/05/2021
Date registered
3/06/2021

Titles & IDs
Public title
Effects of Class III Elastics on Stability of Orthopaedic Class III Correction
Scientific title
Effects of Class III Elastics on Stability of Orthopaedic Class III Correction
Secondary ID [1] 0 0
X19-0365
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Class III Malocclusion 0 0
Underbite 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Upper-lower clear plastic retainers + Class III elastics
Other interventions - Upper-lower clear plastic retainers

Experimental: Upper-lower clear plastic retainers + Class III elastics - Upper-lower clear plastic retainers + Class III elastics

Active comparator: Upper-lower clear plastic retainers - Upper-lower clear plastic retainers


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

Other interventions: Upper-lower clear plastic retainers
Upper-lower clear plastic retainers
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Difference in overjet of participants in the 2 study arms
Timepoint [1] 0 0
5 years
Secondary outcome [1] 0 0
Need for jaw surgery
Timepoint [1] 0 0
5 years
Secondary outcome [2] 0 0
Difference in upper jaw position
Timepoint [2] 0 0
5 years
Secondary outcome [3] 0 0
Difference in lower jaw position
Timepoint [3] 0 0
5 years
Secondary outcome [4] 0 0
Difference in upper-lower jaw relationship
Timepoint [4] 0 0
5 years
Secondary outcome [5] 0 0
Difference in upper incisor angulation
Timepoint [5] 0 0
5 years
Secondary outcome [6] 0 0
Difference in lower incisor angulation
Timepoint [6] 0 0
5 years
Secondary outcome [7] 0 0
Compliance and ease of use of both retention regimens
Timepoint [7] 0 0
5 years
Secondary outcome [8] 0 0
Effect of elastics on alignment retention
Timepoint [8] 0 0
5 years
Secondary outcome [9] 0 0
Periodontal health, including recession around the incisors
Timepoint [9] 0 0
5 years

Eligibility
Key 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
Minimum age
12 Years
Maximum age
16 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* Congenital anomalies or craniofacial syndromes
* Other orthodontic treatment
* Medical history that effects growth

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
NA
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
22/07/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/01/2027
Actual
Sample size
Target
42
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Chatswood Orthodontics - Chatswood
Recruitment hospital [2] 0 0
Sydney Dental Hospital - Surry Hills
Recruitment postcode(s) [1] 0 0
2067 - Chatswood
Recruitment postcode(s) [2] 0 0
2010 - Surry Hills

Funding & Sponsors
Primary sponsor type
Government body
Name
Sydney Local Health District
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Oyku Dalci, DDS, PhD
Address 0 0
Sydney Local Health District, The University of Sydney
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04911400