ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12618001430224

Ethics application status

Approved

Date submitted

19/12/2017

Date registered

27/08/2018

Date last updated

23/03/2023

Date data sharing statement initially provided

30/11/2021

Date results provided

23/03/2023

Type of registration

Retrospectively registered

Titles & IDs

Public title

Botulinum toxin for nocturnal bruxism.

Scientific title

Efficacy of Botulinum Toxin Type A in the Targeted Treatment of Nocturnal Bruxism: A Double-Blind, Randomised, Placebo-Controlled Cross-over Study

Secondary ID [1]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

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

Bruxism

Condition category

Condition code

Neurological

Other neurological disorders

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

The intervention is a set of injections at 2 time points, at least 20 weeks apart, performed by a trained neurologist at Royal Melbourne Hospital. The treatment consists of intramuscular injections of Botox (onabotulinumtoxinA) (dose range of 90-120units as detailed below) and 0.9% normal saline (dose range 1.8ml-2.4ml), in a randomised, double blind, cross-over study.

The doses detailed are based on the minimally clinically effective doses within the range of those used in published studies.

Patients will be randomised to receive injections into:
A. Masseter muscles bilaterally (30 units or 0.6ml normal saline each side);
B. Masseter and temporalis muscles bilaterally (30 units/15 units each muscle respectively, or 0.6ml/0.3ml respectively); or
C. Masseter, temporalis and medial pterygoid muscles bilaterally (30units/15units/15 units each muscle respectively, or 0.6ml/0.3ml/0.3ml normal saline respectively).

The duration of treatment effect for botulinum toxin injected into the face, head and neck area has been observed to be approximately 3-4 months. Therefore a 20-week (5month) washout period was chosen to ensure that there is no remaining active treatment effect before the cross-over set of injections.

At 20 weeks, there will therefore be a single set of injections, of either active treatment or placebo, in the same sites as the first injection, again performed by a trained Neurologist at Royal Melbourne Hospital.

Study investigators will contact the participants to arrange followup within 7 days of the specified timepoint, for clinical assessment and outcome measures. Participants will also be given dates for followup in advance of the scheduled timepoints to ensure fidelity to the intervention followup schedule.

Intervention code [1]

Treatment: Drugs

Comparator / control treatment

Placebo (0.9% normal saline, 1.8-2.4ml)

Control group

Placebo

Outcomes

Primary outcome [1]

Composite primary outcome: change in bruxism severity (objectively measured by overnight surface EMG, validated questionaires addressing bruxism (Bruxism symptom questionnaire), headache (headache impact test (HIT-6) questionnaire, pain (modified Short-Form McGill pain scale) and sleepiness severity (using the Epworth sleepiness scale), following injection of onabotulinum toxin and placebo.

Timepoint [1]

4 weeks following injection of onabotulinum toxin or placebo.

Primary outcome [2]

Safety of botulinum toxin in the treatment of nocturnal bruxism as measured by clinical review. A neurologist will be clinically assessing the participant, discussing any change in health or possible side-effects of the treatment and documenting details.

The possible expected side effects are bruising/discomfort and rarely excessive muscle weakness (manifest as weakness with chewing).

Timepoint [2]

4 weeks following injection of onabotulinum toxin or placebo

Secondary outcome [1]

Duration of benefit following Botulinum toxin injection on symptoms of Bruxism.

Timepoint [1]

Weeks 4, 12, 20 following injection of either placebo or Botulinum toxin

Eligibility

Key inclusion criteria

Symptoms of nocturnal bruxism of adequate severity as measured by overnight monitoring.

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Contraindication to botulinum toxin administration, concurrent use of medications affecting muscle relaxation, prior history of severe jaw trauma, orofacial pain of an alternate aetiology, neuromuscular disease, major respiratory disease(s) that may preclude overnight EMG recordings, administration of botulinum toxin for other indication (including cosmetic) within 16weeks of study commencement.

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)

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 receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data

Intervention assignment

Crossover

Other design features

Phase

Phase 2

Type of endpoint/s

Safety/efficacy

Statistical methods / analysis

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

Actual

5/02/2016

Date of last participant enrolment

Anticipated

Actual

29/11/2019

Date of last data collection

Anticipated

Actual

5/10/2020

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment hospital [1]

Royal Melbourne Hospital - City campus - Parkville

Recruitment postcode(s) [1]

3050 - Parkville

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Melbourne Health

Address [1]

Royal Melbourne Hospital
Grattan Street,
Parkville, VIC 3050

Country [1]

Australia

Primary sponsor type

Hospital

Name

Melbourne Health

Address

Royal Melbourne Hospital
Grattan Street,
Parkville, VIC 3050

Country

Australia

Secondary sponsor category [1]

None

Name [1]

N/A

Address [1]

N/A

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Melbourne Health Human Research Ethics Committee

Ethics committee address [1]

Grattan St, 
Parkville
VIC 3050

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

26/08/2015

Approval date [1]

01/12/2015

Ethics approval number [1]

2015.195

Summary

Brief summary

Bruxism is a diurnal or nocturnal involuntary repetitive oral activity consisting of a non-functional rhythmic (or spasmodic) grinding, clenching or gnashing movement of the teeth. The diagnosis of bruxism is made by reports of tooth grinding/clenching during sleep, and one of either: abnormal tooth wear, sounds associated with bruxism, and/or jaw muscle discomfort. In adults, the prevalence of sleep bruxism is reported to be around 6% for the grinding type and 20% for the clenching type. Sleep bruxism has been linked to a variety of headache syndromes including temporomandibular disorders and chronic migraine. 

The ultimate goal of this research is to develop a more effective therapeutic intervention for bruxism sufferers with the use of BTA injection. Patients will mainly be recruited via the Botulinum Toxin Clinic at Royal Melbourne Hospital, as well as via referrals from dental orofacial pain specialists and neurologists. The study is a randomized, double blind, placebo-controlled trial with a crossover design; the study duration is 40weeks from the time of randomisation. All participants meeting eligibility criteria will be required to consent to approved study protocols.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

A/Prof Lynette Kiers

Address

4N Neurophysiology
Royal Melbourne Hospital
Grattan Street
Parkville
VIC 3050

Country

Australia

Phone

+61 03 93427693

Fax

+61 03 93424085

lynette.kiers@mh.org.au

Contact person for public queries

Name

Belinda Cruse

Address

4N Neurophysiology
Royal Melbourne Hospital
Grattan Street
Parkville
VIC 3050

Country

Australia

Phone

+61 03 93427693

Fax

+61 03 93424085

belinda.cruse@mh.org.au

Contact person for scientific queries

Name

Belinda Cruse

Address

4N Neurophysiology
Royal Melbourne Hospital
Grattan Street
Parkville
VIC 3050

Country

Australia

Phone

+61 03 93427693

Fax

+61 03 93424085

belinda.cruse@mh.org.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

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	Efficacy of botulinum toxin type a in the targeted treatment of sleep bruxism: a double-blind, randomised, placebo-controlled, cross-over study.	2022	https://dx.doi.org/10.1136/bmjno-2022-000328

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

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Documents added manually

Documents added automatically