Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001488291p
Ethics application status
Submitted, not yet approved
Date submitted
29/08/2018
Date registered
5/09/2018
Date last updated
5/09/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Daytime tooth clenching in musicians; does wearing a thin plastic tooth cover help reduce it?
Scientific title
An assessment of the effect in a group of musicians of wearing a plastic tooth cover to relieve the symptoms of awake bruxism.
Secondary ID [1] 295931 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Awake bruxism 309428 0
Temperomandibular disorders 309433 0
Tooth clenching 309475 0
Condition category
Condition code
Oral and Gastrointestinal 308281 308281 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
All participants in the clinical study will attend a dental clinic in Sydney CBD to have a dental impression taken of their lower teeth. At that time they will also be given written and verbal advice about avoiding daytime tooth contact (awake bruxism - AB).
This advice is available in: -
Management of Temperomandibular Disorders & Occlusion 7th Edition 2012 Elsevier; Mosby
Hardcover ISBN: 9780323082204
Shortly after that the participants will be divided, non-randomly into study group and control group such that the two groups will be age and gender matched.
This is important as symptoms from this behaviour are known to be more prevalent in females and to decline with age.
A thin transparent lower tooth cover will be made on the plaster models derived from the dental impression for members of the study group. This is made from a square blank of the plastic material on a thermoforming machine using heat and suction to pull the blank onto the plaster model. The excess is trimmed off, the tooth cover is trimmed and polished.
The study group participants will wear the tooth cover daily for a period of 3 months. They may put it in their mouths and take it out as often as they wish during the day.
They will be advised to wear it for some period of time every day.
There is no minimum length of time daily that the tooth cover should be worn.
It could be that frequent insertion and removal of the cover is as valuable as wearing it in terms of generating awareness of tooth clenching.
The frequency of use is one of the questions in the questionnaire at the end of the trial.
Study group participants will be issued with their tooth covers at the same dental clinic in Sydney where impressions were taken. They will be given written and verbal advice on the use and care of the tooth covers.
This advice is designed specifically for this study.
The lead researcher and his co-researcher will deliver all clinical aspects of the trial.
Both researchers are registered dentists. The co-researcher has 10 years clinical experience. The lead researcher has 50 years clinical experience. Both individuals have carried out the clinical procedures needed many times.
Intervention code [1] 312254 0
Treatment: Devices
Comparator / control treatment
The control group will have had a dental impression taken of their lower teeth.
They will also be given general advice (written and verbal) on how to avoid daytime tooth clenching (awake bruxism)
Control group
Active

Outcomes
Primary outcome [1] 307247 0
Frequency of headache.assessed by questionnaire at the conclusion of the trial.
As no suitable questionnaire was found by reviewing the literature, this questionnaire has been designed specifically for this study.
Timepoint [1] 307247 0
3 months after intervention commencement.
Primary outcome [2] 307248 0
Frequency of daytime tooth contact or jaw thrusting to be assessed by questionnaire at the conclusion of the trial.
As no suitable questionnaire was found by reviewing the literature, this questionnaire has been designed specifically for this study.
Timepoint [2] 307248 0
3 months after the intervention commencement.
Primary outcome [3] 307282 0
Incidence of mouth, face, head, neck and shoulder pain to be assessed by questionnaire at the conclusion of the trial.
As no suitable questionnaire was found by reviewing the literature, this questionnaire has been designed specifically for this study.
Timepoint [3] 307282 0
3 months after the intervention commencement.
Secondary outcome [1] 351260 0
The degree to which symptoms affect a musician's ability to play their instrument.
To be assessed by questionnaire at the conclusion of the trial.
As no suitable questionnaire was found by reviewing the literature, this questionnaire has been designed specifically for this study.
Timepoint [1] 351260 0
3 months after the intervention commencement.
Secondary outcome [2] 351261 0
Qualitative questions about the intervention in the questionnaire at the conclusion of the
trial; -
Was the intervention helpful?
If yes, in what way was it helpful?
How often was it worn and for how long.
Was it worn rehearsing, performing or at other times?
Timepoint [2] 351261 0
3 months after the intervention commencement.

Eligibility
Key inclusion criteria
The study is only available to students and staff of The Sydney Conservatorium of Music,
It is not conditional on any preconditions.
We know from the literature that musicans suffer from many musculo-skeletal problems. as well as looking for daytime tooth clenchers we are interested in all mouth, face, head, neck and shoulder symptoms.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Not belonging to the inclusion criteria.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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 administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
For the clinical trial N=30 since this allows us to invoke the Central Limit Theorem and assume nromality, meaning we can use simple t-tests, Anova and create confidence intervals for the mean.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2019
Actual
Date of last participant enrolment
Anticipated
26/07/2019
Actual
Date of last data collection
Anticipated
1/11/2019
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 23830 0
2000 - Sydney

Funding & Sponsors
Funding source category [1] 300529 0
Self funded/Unfunded
Name [1] 300529 0
Dr David A Graham (Dentist)
Country [1] 300529 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
City Road,
Camperdown/Darlington NSW 2006
Country
Australia
Secondary sponsor category [1] 300006 0
None
Name [1] 300006 0
Address [1] 300006 0
Country [1] 300006 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 301317 0
University of Sydney HREC
Ethics committee address [1] 301317 0
City Road
Camperdown/Darlington NSW 2006
Ethics committee country [1] 301317 0
Australia
Date submitted for ethics approval [1] 301317 0
28/08/2018
Approval date [1] 301317 0
Ethics approval number [1] 301317 0

Summary
Brief summary
Daytime tooth clenching can cause broken teeth, headaches and face pain. This study is examining a way of managing awake bruxism by using a thin tooth cover to create awareness of the behaviour. Does this reduce tooth clenching and therefore reduce broken teeth, headache and face pain?
Hypothesis:
Wearing a thin tooth cover will create awareness of tooth clenching leading to a reduction in the behaviour and therefore a reduction in the effects of the behaviour.
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 3064 3064 0 0
/AnzctrAttachments/375889-Clinical Trial Protocol awake bruxism study.docx (Protocol)

Contacts
Principal investigator
Name 86614 0
Prof Greg Murray
Address 86614 0
Westmead Centre for Oral Health
Darcy Road
Westmead NSW 2145
The University of Sydney
NSW 2006 AUSTRALIA
Country 86614 0
Australia
Phone 86614 0
Telephone: +61 2 8890 6380
Fax 86614 0
Email 86614 0
[email protected]
Contact person for public queries
Name 86615 0
Dr David A Graham (Dentist)
Address 86615 0
Paramount Dental Sydney
Suite 601, St. James Trust Building
185 Elizabeth Street
Sydney NSW 2000
Country 86615 0
Australia
Phone 86615 0
+61 2 9267 8540
Fax 86615 0
+61 2 9267 5195
Email 86615 0
[email protected]
Contact person for scientific queries
Name 86616 0
Prof Greg Murray
Address 86616 0
Westmead Centre for Oral Health
Darcy Road
Westmead NSW 2145
The University of Sydney
NSW 2006 AUSTRALIA
Country 86616 0
Australia
Phone 86616 0
Telephone: +61 2 8890 6380
Fax 86616 0
Email 86616 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

Current supporting documents:


Updated to:
Doc. No.TypeCitationLinkEmailOther DetailsAttachment
23675Study protocol  [email protected]
23676Informed consent form  [email protected]

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.