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Trial registered on ANZCTR


Registration number
ACTRN12618000607279
Ethics application status
Approved
Date submitted
14/03/2018
Date registered
19/04/2018
Date last updated
29/03/2019
Date data sharing statement initially provided
29/03/2019
Date results information initially provided
29/03/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
A feasibility study to measure the Jaw opening forces in subjects diagnosed with Temporomandibular disorders.
Scientific title
A feasibility study to investigate the effectiveness and acceptability of jaw opening forces as a screening tool to diagnose patients with certain Temporomandibular disorders.
Secondary ID [1] 294325 0
Nil
Universal Trial Number (UTN)
U111111995896
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
myofacial pain 307044 0
Temporomandibular joint (TMJ) pain 307358 0
clicking and popping of the TMJ 307359 0
Condition category
Condition code
Oral and Gastrointestinal 306145 306145 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Musculoskeletal 306281 306281 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Diagnosis will be carried out by the TMD specialist by careful evaluation of the history and detailed examination of the masticatory apparatus according to the TMD diagnostic questionnaire used in the TMJ clinic at the Faculty of Dentistry, University of Otago. Patients will be divided into three categories based on the TMD diagnosis (Myofacial pain, disc dislocation and both of the above). The maximum jaw opening forces in patients diagnosed with the TMDs included in the study will be measured during their initial visit to the clinic.
Patients who have given informed consent to be involved in the study will be asked to attend a 20-30min session where they will wear a head device designed to measure jaw opening forces. The device is connected to a data-capture system . After device placement, participants will be asked to open their jaw a few times so they get used to the equipment. With their jaws held together in centric position, participants will then be asked to attempt open their jaws as forcefully as possible for 2 seconds 7 times, pausing for a 10 second interval between each attempt. The jaw opening forces will then be recorded in the data capture system. During this visit, the patient would normally receive treatment depending on the severity of the TMD. Following treatment, the maximum jaw opening forces for each patient will be measured during their review appointments at 1, 3 and 6 months.
Intervention code [1] 300634 0
Early Detection / Screening
Comparator / control treatment
The maximum jaw opening forces in healthy subjects (exclusion criteria included patients with myofascial pain, temporomandibular joint disorders, undergoing orthodontic treatment or edentulous patients) will be used as a control group. The jaw opening forces in the healthy subjects will be measured only during their baseline appointment. The jaw opening forces in the healthy subjects wont be measured at 1,3 and 6 months.
Control group
Active

Outcomes
Primary outcome [1] 305161 0
Acceptability of the jaw opening device as a screen tool to diagnose TMDs assessed with a questionnaire designed specifically for this study.
Timepoint [1] 305161 0
Pre treatment (baseline) and after treatment at 1, 3 and 6 months
Primary outcome [2] 305163 0
To measure the maximum jaw opening forces using the jaw opening device (the device is connected to a date capturing system) in patients diagnosed with different types of TMDs listed below,
1. Subjects with myofascial pain
2. Subjects with TMJ pain (clicking at the joint, locking of the jaw)
3. Patients who show both myofascial and TMJ pain
Timepoint [2] 305163 0
pre treatment and after after treatment 1, 3 and 6 months
Secondary outcome [1] 344733 0
To measure the maximum jaw opening forces between healthy subjects and patients diagnosed with TMDs using the jaw opening device (The device is connected to a data capturing system).
Timepoint [1] 344733 0
Baseline

Eligibility
Key inclusion criteria
Inclusion criteria for TMD patients: Patients with myofacial pain, patients with temporomandibular joint pain and patients having both myofacial pain and temporomandibular joint pain. Males and females ageing (18 - onwards) of all ethnicities will be invited to participate.

Inclusion criteria for healthy subjects: Subjects who has good general and oral health (subjects who does not have myofacial pain and temporo-mandibular joint disorders). Males and females aging 20- onwards of all ethnicities will be invited to participate.
Minimum age
20 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
TMD patients: Patients with osteoarthritis
Control group: Subjects who have myofacial pain and temporomandibular joint disorders.

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Convenience sample
Timing
Retrospective
Statistical methods / analysis
This is a pilot/feasibility study. Therefore, no power calculation is required. A statistical analysis (one-way ANOVA) will be conducted to assess whether there is a statistically significant difference in the maximum jaw opening forces following treatment. A statistical analysis of p <0.05 would consider significant.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 9683 0
New Zealand
State/province [1] 9683 0
Otago

Funding & Sponsors
Funding source category [1] 298971 0
University
Name [1] 298971 0
Faculty of Dentistry, University of Otago
Address [1] 298971 0
310 Great King Street
Dunedin 9016
New Zealand
Country [1] 298971 0
New Zealand
Primary sponsor type
University
Name
University of Otago
Address
Faculty of Dentistry,
University of Otago.
310 Great King St, North Dunedin
Dunedin 9016
New Zealand
Country
New Zealand
Secondary sponsor category [1] 298201 0
None
Name [1] 298201 0
Address [1] 298201 0
Country [1] 298201 0
Other collaborator category [1] 280014 0
Individual
Name [1] 280014 0
Dr Jithendra Ratnayake
Address [1] 280014 0
Sir John Walsh Research Institute
71 Frederick Street
North Dunedin
Dunedin 9016
Country [1] 280014 0
New Zealand
Other collaborator category [2] 280015 0
Individual
Name [2] 280015 0
Dr Carolina Loch
Address [2] 280015 0
Faculty of Dentistry
University of Otago
310 Great King Street
Dunedin 9016
Country [2] 280015 0
New Zealand
Other collaborator category [3] 280016 0
Individual
Name [3] 280016 0
Dr Ajith Polonowita
Address [3] 280016 0
Faculty of Dentistry
University of Otago
310 Great King Street
Dunedin 9016
New Zealand
Country [3] 280016 0
New Zealand
Other collaborator category [4] 280017 0
Individual
Name [4] 280017 0
Associate Professor Neil Waddell
Address [4] 280017 0
Faculty of Dentistry
University of Otago
310 Great King Street
Dunedin 9016
New Zealand
Country [4] 280017 0
New Zealand
Other collaborator category [5] 280018 0
Individual
Name [5] 280018 0
Dr Kc Li
Address [5] 280018 0
Faculty of Dentistry
University of Otago
310 Great King Street
Dunedin 9016
New Zealand
Country [5] 280018 0
New Zealand
Other collaborator category [6] 280019 0
Individual
Name [6] 280019 0
Dr Simon Guan
Address [6] 280019 0
Faculty of Dentistry
University of Otago
310 Great King Street
Dunedin 9016
New Zealand
Country [6] 280019 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299902 0
Health and Disability Ethics Committee
Ethics committee address [1] 299902 0
Ministry of Health
Ethics Department
Freyberg Building
Reception – Ground Floor
20 Aitken Street
Wellington 6011
Ethics committee country [1] 299902 0
New Zealand
Date submitted for ethics approval [1] 299902 0
21/08/2017
Approval date [1] 299902 0
26/10/2017
Ethics approval number [1] 299902 0
17/NTB/171

Summary
Brief summary
Temporomandibular disorders (TMDs) affect the articulatory system, consisting of the temporomandibular joints, mandibular muscles and occlusion. TMDs can result in pain and disability and can affect daily activities, quality of life and psychological wellbeing.
Several studies have shown that multiple factors such as trauma to the teeth or jaw, bruxism, stress and anxiety contribute towards TMDs. Until now, the screening of TMDs has been based on indirect and subjective measures. However, so far, no studies have used jaw opening forces as a screening tool for diagnosing TMDs. Jaw movements are the only parameters that can be objectively recorded and measured. Jaw opening is important not only as a record of the severity of the TMDs being investigated but also as an indication of the rate and degree of improvement. This study will focus on the maximum jaw opening forces in subjects diagnosed with a TMD and would provide a quantitative diagnostic tool to screen temporomandibular disorders. The maximum jaw opening forces in patients diagnosed with certain TMDs will be measured during their initial visit to the clinic using a rigid jaw opening measuring system. The patient would normally receive treatment depending on the severity of the temporomandibular disorder. Following treatment, the maximum jaw opening forces for each patient will be measured during their review appointments at 1, 3 and 6 months.
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 2504 2504 0 0
Attachments [3] 2507 2507 0 0
Attachments [4] 2508 2508 0 0
Attachments [5] 2509 2509 0 0

Contacts
Principal investigator
Name 81930 0
Prof Paul Brunton
Address 81930 0
Faculty of Dentistry, University of Otago
310 Great King Street
Dunedin 9054
PO Box 647
Country 81930 0
New Zealand
Phone 81930 0
+6434797039
Fax 81930 0
Email 81930 0
paul.brunton@otago.ac.nz
Contact person for public queries
Name 81931 0
Prof Paul Brunton
Address 81931 0
Faculty of Dentistry, University of Otago
310 Great King Street
Dunedin 9054
PO Box 647
Country 81931 0
New Zealand
Phone 81931 0
+6434797039
Fax 81931 0
Email 81931 0
paul.brunton@otago.ac.nz
Contact person for scientific queries
Name 81932 0
Prof Paul Brunton
Address 81932 0
Faculty of Dentistry, University of Otago
310 Great King Street
Dunedin 9054
PO Box 647
Country 81932 0
New Zealand
Phone 81932 0
+6434797039
Fax 81932 0
Email 81932 0
paul.brunton@otago.ac.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
All data will be confidential.
What supporting documents are/will be available?
Study protocol
Informed consent form
Ethical approval
How or where can supporting documents be obtained?
Type [1] 1754 0
Informed consent form
Citation [1] 1754 0
Link [1] 1754 0
Email [1] 1754 0
Other [1] 1754 0
Consent sheet
Type [2] 1755 0
Study protocol
Citation [2] 1755 0
Link [2] 1755 0
Email [2] 1755 0
Other [2] 1755 0
Study protocol
Type [3] 1756 0
Ethical approval
Citation [3] 1756 0
Link [3] 1756 0
Email [3] 1756 0
Other [3] 1756 0
Ethical approval
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
No
Results – basic reporting
Results – plain English summary