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Trial registered on ANZCTR

Registration number

ACTRN12617001136392

Ethics application status

Approved

Date submitted

31/07/2017

Date registered

3/08/2017

Date last updated

3/08/2017

Type of registration

Prospectively registered

Titles & IDs

Public title

A randomized control trial investigating the effectiveness of three different upper jaw expansion devices in correcting narrow upper jaws in 10-16 year old children.

Scientific title

Randomized clinical trial investigating the airway, facial, dental and skeletal changes from bone and tooth anchored rapid palatal expansion (Hybrid Hyrax) versus tooth borne rapid palatal expansion (Hyrax) versus a novel keyless tooth borne palatal expansion device in 10-16 year old children.

Secondary ID [1]

Nil

Universal Trial Number (UTN)

U1111-1199-8765

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Constricted Maxilla

Condition category

Condition code

Oral and Gastrointestinal

Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

All patients recruited to this research will be given one of three different information brochures, (Parents; 10-12 year olds, and 12-16 year olds) with each adjusted to the relavent reading age. Each brochure has information regarding the three different possible interventions; possible side effects; participation requirements and contact information of the researchers. Prior to the intervention, patients will have photos, 3d photographic scans, study casts of their teeth, and cone beam CT taken to record as baseline values.
There are three seperate intervention arms: Arm 1: Hyrax expansion group (which will act as control) Arm 2: Hybrid Hyrax expansion group, Arm3: Keles expansion group.
These will all be performed at the Sydney Dental Hospital by three different training Orthodontic registrars under the supervision of one professor and two senior lectures who have a minimum of 15 years experience in Orthodontics.

Once recruited, each patient is randomized into one of three arms. The key difference in the interventions is described below
Arm 1 Hyrax: to use a conventional expansion device which is attached only to the first upper premolars and upper first molars
Arm 2 Hybrid Hyrax: to use a conventional expansion device which is attached to the first upper molars but also to two mini implants that are placed in the palate
Arm 3 Keles Expansion: A novel expansion device which is similar to the conventional expansion device in action and attached to the upper first premolars and molars, with the only difference being that the device has a built in operating arm, whereas the conventional expansion device requires an external key.

In all three groups, the participants will be instructed to turn the expansion device twice a day, resulting in 0.5mm of expansion a day. The use of the device will be demonstrated to the patient and their guardians, as well as an instructional video given for home viewing. Interventional adherence will be monitored by using a calendar and patients reviewed on a weekly basis. They will be continued to be monitored weekly at Sydney Dental hospital until it is determined that an adequate amount of expansion has been achieved and then instructed to stop turning. This will be determined by the orthodontic registar and defined as when there is no longer a posterior crossbite between the upper and lower dentition. The expansion device will then be locked so that no further turning can occur. Patients will then have 6 months of the devices in situ to stabilize the expansion. After 6 months the devices will be removed and new records taken.
Fixed orthodontic appliances will then be placed to correct any further orthodontic issues.

Intervention code [1]

Treatment: Devices

Comparator / control treatment

The control group will be Arm1 of the research, and consists the use of a conventional Hyrax expansion device, which has been used in Orthodontics since 1968. The procedure of turning and mechanism of turning will be identitical to the other arms.

Control group

Active

Outcomes

Primary outcome [1]

Change in the angulation of the palatal root of the first molar to the palatal plane (Tor) as assesed in the sagittal view on Cone Beam CT slices.

Timepoint [1]

Will be assesed on Cone Beam CT images taken before treatment (T0), and taken immediately after appliance removal (T1) - which will be 6 months after active expansion.

Secondary outcome [1]

Easability of each device

Timepoint [1]

Two surverys specific to the study will be given to patients immediately after appliance insertion and immediately after appliance removal. These will be labelled "Questionnaire 1" and "Questionnaire 2". The only difference between the two being the addition of an extra question asking the patient to clarify how many turns they have completed of the appliance during the active treatment period. There will be a Visual Analog scale from 0-10, with 10 being a postive response, and 0 being a negative response.

Secondary outcome [2]

Changes in nasal floor width as assessed on sagittal slices of Cone Beam CT

Timepoint [2]

Will be assesed on Cone Beam CT images taken before treatment (T0), and taken immediately after appliance removal (T1) - which will be 6 months after active expansion.

Secondary outcome [3]

Changes in Hard palate width as measured on Cone Beam CT slices

Timepoint [3]

Will be assesed on Cone Beam CT images taken before treatment (T0), and taken immediately after appliance removal (T1) - which will be 6 months after active expansion.

Secondary outcome [4]

Changes in upper airway volume as measured on Cone Beam CT using a segmentation technique.

Timepoint [4]

Will be assesed on Cone Beam CT images taken before treatment (T0), and taken immediately after appliance removal (T1) - which will be 6 months after active expansion.

Eligibility

Key inclusion criteria

Transverse discrepancy between the maxilla and mandible to be more than 5mm as measured from the upper first molar palatal cusp tips to the lower first molar groove

Erupted permanent maxillary first molars and first premolars

Minimum age

10 Years

Maximum age

16 Years

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

o Unerupted permanent maxillary first premolars or first molars
o History of previous orthodontic treatment
o Women who are pregnant
o People with an intellectual or mental impairment
o People highly dependent on medical care
o History of congenital deformity
o Periodontal disease
o Surgical treatment that may affect the rapid maxillary expansion outcome

Study design

Purpose of the study

Treatment

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Central randomization by computer randomisation.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

o We will allocate each patient a number from 1-75, and then utilising the following (randomizer.org) we will randomly generate the three treatment arms with these allocated numbers.

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Parallel

Other design features

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

The assessment of Tor (the change in angulation of palatal root to palatal plane)
SD: 1.5
A significant difference of 2°
To use the t-test twice to compare the two groups relative to control (Hyrax) - Hyrax vs Keles and Hyrax vs Hybrid-Hyrax
a = 0.025, 1-a = 0.975
Power = 90%
Patients required = 15 per group
To accommodate for drop outs, N= 60

Recruitment

Recruitment status

Not yet recruiting

Date of first participant enrolment

Anticipated

1/09/2017

Actual

Date of last participant enrolment

Anticipated

1/12/2017

Actual

Date of last data collection

Anticipated

1/06/2018

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW

Recruitment hospital [1]

Sydney Dental Hospital - Surry Hills

Recruitment postcode(s) [1]

2010 - Surry Hills

Funding & Sponsors

Funding source category [1]

University

Name [1]

University of Sydney

Address [1]

Orthodontic Department of University of Sydney
Level 2, Sydney Dental Hospital,
2 Chalmers Street
Surry Hills
Sydney 2010
New South Wales

Country [1]

Australia

Primary sponsor type

Hospital

Name

Sydney Dental Hospital

Address

Sydney Dental Hospital,
2 Chalmers Street
Surry Hills
Sydney 2010
New South Wales

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Sydney Local Health District Human Research Eethics Committee

Ethics committee address [1]

Research Ethics and Governance Office (REGO)
Royal Prince Alfred Hospital
Missenden Road
CAMPERDOWN NSW 2050

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

14/03/2017

Approval date [1]

18/07/2017

Ethics approval number [1]

x17-0075

Summary

Brief summary

This study is to find if one type of expander (a plate) is better at widening the upper jaw of children aged 10-16. The expander will be placed on their top teeth and will be one of the following:

1) Hyrax Expander: this is the common type of expander which requires a separate key to turn. 
2) Hybrid-Hyrax Expander: this is the normal expander but it also includes two pins placed in the top of the upper jaw (palate) 
3) Keles Expander: this is a new type of expander which has a built-in key to turn the expander. This new type of expander is not yet approved by Therapeutic Goods Administration.

Our hypothesis is that the Keles expander will work as equally as effectively as the Hyrax, whereas the Hybrid-Hyrax will be more effective in expanding the jaw due to the use of the two palatal pins.
Patients will be recruited at the Sydney Dental Hospital and will be included if they meet the inclusion criteria of having a narrow jaw and in the correct age range. Exclusion criteria include if patients have had previous orthodontic treatment and/or any serious health issues that may impact orthodontic treatment.
60 selected patients will be randomly placed into 3 groups of 20 patients each. Records of patients will be taken before treatment. The appliance will be constructed and installed on each patient. Patients will be taught to turn the expander and will continue expanding until the correct amount of expansion has been achieved. After this, the expander will be locked to prevent further turning and the patient left with the expander in-situ for 6 months to retain the changes in the expanded jaw. The expander is then removed and then new records taking. Patients are then followed up to continue with normal braces treatment as per normal.

The records taken of participants will include: questionaires, photos, study casts, 3d photos, and Cone Beam CT images. 
The data retrieved from these records will be used to assess the dental, skeletal, facial and airyway changes as a result of the expansion. The primary outcome will be to assess the change in angulation of upper first molars relatve to the palate in cross section on Cone Beam CT images. Secondary outcomes include: easability of the difference appliances, airway changes, facial changes and skeletal changes measured on CT images..

Trial website

Trial related presentations / publications

Public notes

Attachments [1]

/AnzctrAttachments/373376-Protocol v1.3 clean copy.docx (Protocol)

Attachments [2]

/AnzctrAttachments/373376-0757_001.pdf (Ethics approval)

Attachments [3]

/AnzctrAttachments/373376-Information sheet for adolescents v1.2 Final.docx (Participant information/consent)

Attachments [4]

/AnzctrAttachments/373376-Information sheet for children 1.3 Final.docx

Attachments [5]

/AnzctrAttachments/373376-Information sheet for parents 1.3 Final.docx (Participant information/consent)

Attachments [6]

/AnzctrAttachments/373376-RME Parent Guardian Consent Form 1.2 Final.doc (Participant information/consent)

Attachments [7]

/AnzctrAttachments/373376-RME Participant Consent Form 1.3 Final.doc (Participant information/consent)

Contacts

Principal investigator

Name

Prof Mehmet Ali Darendililer

Address

Orthodontic Department
Level 2, Sydney Dental Hospital
2 Chalmers Street
Surry Hills 2010
New South Wales

Country

Australia

Phone

+612 93518314

Fax

Ali.darendeliler@sydney.edu.au

Contact person for public queries

Name

Gordon Cheung

Address

Orthodontic Department
Level 2, Sydney Dental Hospital
2 Chalmers Street
Surry Hills 2010
New South Wales

Country

Australia

Phone

+612 93518314

Fax

gche6490@uni.sydney.edu.au

Contact person for scientific queries

Name

Gordon Cheung

Address

Orthodontic Department
Level 2, Sydney Dental Hospital
2 Chalmers Street
Surry Hills 2010
New South Wales

Country

Australia

Phone

+612 93518314

Fax

gche6490@uni.sydney.edu.au

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	The upper airway volume effects produced by Hyrax, Hybrid-Hyrax, and Keles keyless expanders: a single-centre randomized controlled trial.	2021	https://dx.doi.org/10.1093/ejo/cjaa031

N.B. These documents automatically identified may not have been verified by the study sponsor.

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