Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000045718
Ethics application status
Approved
Date submitted
14/01/2013
Date registered
15/01/2013
Date last updated
17/01/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
The immediate effect of changing mandibular position on airway and head position.
Scientific title
In an adult population does altering the mandibular position from maximum intercuspal position to centric relationship and phonetic bite position immediately alter airway and head position.
Secondary ID [1] 281767 0
None
Universal Trial Number (UTN)
U1111-1135-6187
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Airway size 288076 0
Condition category
Condition code
Oral and Gastrointestinal 288449 288449 0 0
Normal oral and gastrointestinal development and function

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The principal clinician will perform all maxillo-mandibular (mx/md) registrations. The centric relation bite registration will be taken in the supine position following a method using an anterior jig. The posterior registration will be recorded using vinyl polysiloxone. The participant will be guided into the anterio-superior position and absence of pain on loading is confirmed. The phonetic bite position participants will have their mx/md relationship captured when they repeat the sound "Mississippi-miss" and the anterior position will be captured by asking them to close lightly onto a cylindrical object whilst the posterior teeth relationship is captured using vinyl polysilioxone. These registrations require 10 minutes disclusion of the teeth before each registration is recorded and repeated if inaccurate. The maximum intercuspal position does not need a recording. The cervical range of motion(CROM) device is fitted and after 15 minutes of habituation head position for one of the three maxillo-mandibular positions is read and immediately an airway test at the same head position using a pharyngometer at functional residual capacity is recorded three times and averaged. The other two mx/md relationships are recorded in the same way after 15 minutes of habituation.
Intervention code [1] 286313 0
Not applicable
Comparator / control treatment
Participants will be own observational controls their airway and head position being assessed in three positions.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 288617 0
The size of the cross-sectional area of the airway will be assessed using "Eccovision" pharyngometer.
Timepoint [1] 288617 0
15 minutes after changing the mandibular position
Secondary outcome [1] 300601 0
The change in head position will be assessed using a cervical range of motion device (CROM).
Timepoint [1] 300601 0
15 minutes after changing the mandibular position.

Eligibility
Key inclusion criteria
All patients at Advanced Dental over 18 years of age
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Under 18 years. Participants who cannot have a bite registration taken due to not having enough teeth. Participants who cannot be load tested in centric relationship. Participants who are unable to perform the acoustic pharyngometry test due to pulmonary, intellectual or motor control disorders.

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
11/02/2013
Actual
Date of last participant enrolment
Anticipated
24/05/2013
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
70
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 4787 0
New Zealand
State/province [1] 4787 0
Nelson

Funding & Sponsors
Funding source category [1] 286546 0
Self funded/Unfunded
Name [1] 286546 0
Gerard Quin
Country [1] 286546 0
New Zealand
Primary sponsor type
Individual
Name
Gerard Quin
Address
70 Collingwood Street
Nelson 7010
Country
New Zealand
Secondary sponsor category [1] 285335 0
None
Name [1] 285335 0
None
Address [1] 285335 0
Country [1] 285335 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288619 0
Health and Disability Ethics Committee
Ethics committee address [1] 288619 0
Ethics committee country [1] 288619 0
New Zealand
Date submitted for ethics approval [1] 288619 0
Approval date [1] 288619 0
21/12/2012
Ethics approval number [1] 288619 0
12/STH/52

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

Contacts
Principal investigator
Name 37002 0
Dr Gerard Quin
Address 37002 0
70 Collingwood Street
Nelson 7010
Country 37002 0
New Zealand
Phone 37002 0
+64 3 5484675
Fax 37002 0
+64 3 5484675
Email 37002 0
gquin@xtra.co.nz
Contact person for public queries
Name 37003 0
Gerard Quin
Address 37003 0
70 Collingwood Street
Nelson 7010
Country 37003 0
New Zealand
Phone 37003 0
+64 3 5484675
Fax 37003 0
+64 3 5484675
Email 37003 0
gquin@xtra.co.nz
Contact person for scientific queries
Name 37004 0
Gerard Quin
Address 37004 0
70 Collingwood Street
Nelson 7010
Country 37004 0
New Zealand
Phone 37004 0
+64 3 5484675
Fax 37004 0
+64 3 5484675
Email 37004 0
gquin@xtra.co.nz

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
No additional documents have been identified.