Sleep BruxismPhase 4BBPNCT01336439
Effects of Botulinum Toxin Type A(Meditoxin®) on Sleep Bruxism
A Phase 4 study testing Botulinum toxin type A (Meditoxin®) in people with Sleep Bruxism, run by Yonsei University at 1 site in South Korea.
Trial summary
The purpose of this study is to evaluate the effect of Botulinum toxin type A(Meditoxin®) on bruxism using polysomnography and determine which site is most appropriate for injection to obtain maximal effects. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Sleep Bruxism
- What is being tested?
- Botulinum toxin type A (Meditoxin®)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2011to Dec 2011
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- clinical diagnosis of sleep bruxism confirmed by wear facets on occlusal splint
- must be able to follow clinical trial procedure
- who are suitable for this clinical trial
- who participated in this clinical trial out of his own free will
Who cannot join
- who take medications such as benzodiazepine or muscle relaxants
- who have secondary bruxism due to brain injury
- who are pregnant or have the possibility of pregnancy
- who had an botulinum toxin injection during the past three months
- who had an allergic reaction history to botulinum toxin
- who have an infection or skin trouble on injection site
Show all 10Show fewer
- who have an other treatment plan for bruxism
- who are enrolled in other clinical trials
- who are not suitable for this clinical trials
- who have mandibular dyskinesia or mandibular dystonia
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Yonsei University dental hospital
Seoul, Sedaemun-gu
YoungJoo Shim, M.S.D., 82-2-2228-8875, yjshim@yuhs.ac
HyungUk Park, D.D.S., 82-2-2228-8879, park777@yuhs.ac
About this study
Official title: Effects of Botulinum Toxin Type A(Meditoxin®) on Sleep Bruxism by Different Injection Sites Evaluated by Polysomnography
The purpose of this study is to evaluate the effect of Botulinum toxin type A(Meditoxin®) on bruxism using polysomnography and determine which site is most appropriate for injection to obtain maximal effects.
Read the detailed description
Bruxism is an oral habit consisting of involuntary non-functional gnashing, clenching, grinding of teeth and is a very common condition in the general population. Various treatment modalities such as occlusal splints, pharmacologic agent and cognitive-behavioral therapy have been investigated for the management of bruxism, but none is reported to be fully effective. Recently locally injected botulinum toxin has been used in various movement disorders, but its usefulness and objective effects on nocturnal bruxism have not been evaluated using objective measures such as polysomnography. Moreover, there is no systematic study about which site is most appropriate for injection to obtain maximal effects.
The aim of this study is to evaluate the effect of botulinum toxin type A into masseter muscle or both masseter muscle and temporal muscle on nocturnal bruxism using polysomnography and the changes in the bruxism events on polysomnography.
- Conditions
- Sleep Bruxism
- Being tested
- Botulinum toxin type A (Meditoxin®)
- Keywords
- Bruxism, Polysomnography, Botulinum toxin type A, Masseter muscle, Temporal muscle
- Medical subject headings
- Sleep Bruxism, Bruxism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Botulinum toxin type A (Meditoxin®)Drug
Also called Meditoxin®(PacificPharm corporation, Korea)
In this study, the botulinum toxin type A (Meditoxin®)was supplied as a freeze-dried powder of 200U, and was reconstituted with 4ml of sterile saline to a concentration of 5U/0.1ml.
After pre-injection polysomnography, botulinum toxin type A was injected into each side bilaterally using a 1ml-syringe with a 29-gauge, and a 1/2-inch needle. The "M group" had an injection in masseter muscle. The "MT group" had an injection in masseter and temporal muscle. A total of 25U of botulinum toxin type A was injected into each site.
After 4 weeks, the subjects had a post-injection polysomnography.
| Study group | Role | What they receive |
|---|---|---|
| M group | Active comparator | A total of 25U of botulinum toxin type A was injected into each side masseter muscle in this arm. Receives: Drug: Botulinum toxin type A (Meditoxin®) |
| MT group | Active comparator | A total of 25U of botulinum toxin type A was injected into each side masseter and temporal muscle in this arm. Receives: Drug: Botulinum toxin type A (Meditoxin®) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change of bruxism events
Before and after injection, we compared the change of bruxism event in polysomnography by sleep laboratory criteria.
<Sleep laboratory criteria>
- Mean SB EMG potential : >10% or 20% of the maximal clench while awake (masseter muscles)
In M group, Botulinum toxin was injected into masseter muscle. In TM group, Botulinum toxin was injected into masseter muscle and temporal muscle.
Measured: At 4 weeks after Botulinum toxin type A injection
Secondary outcomes (4)
The change of masticatory force(%)
We evaluated the change of subjective masticatory force before and after the injection. We asked the subject that "when the masticatory force before injection is represented 100%, what the masticatory force after injection?"
Measured: At 4 weeks after Botulinum toxin type A injection
The change of Pain
We asked the subject about change of pain if the subject has pain on masseter muscle due to myogeneous problem. Pain score was chosen from a scale of zero to 10, where zero represented 'no pain' and 10 represented 'the worst pain they had ever experienced' (Numerical rating scale, NRS)
Measured: At 4 weeks after Botulinum toxin type A injection
Sleep-related movement disorders
The percentage of subjects who have sleep-related movement disorders(ex, Restless Legs Syndrome, Periodic Limb Movement Disorder, Sleep Related Leg Cramps, Sleep Related Rhythmic Movement Disorder Sleep Related Movement Disorder, Unspecified)except sleep related bruxism
Measured: At 4 weeks after Botulinum toxin type A injection
Sleep-related breathing disorders
The percentage of subjects who have sleep-related breathing disorders(ex, Obstructive Sleep apnoea, Sleep Related Hypoventilation/Hypoxaemic syndromes, sleep Related Non-obstructive Alveolar Hypoventilation(idiopathic), Sleep apnoea/Sleep Related Breathing Disorder, Unspecified and etc.)
Measured: At 4 weeks after Botulinum toxin type A injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2011 (estimated)
- Study startMar 2011
- Primary completionAug 2011 (estimated)
- Study completionDec 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep BruxismStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Investigators
- SeongTaek Kim, PhD, Study chair, Yonsei University dental hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01336439
- Sponsor's protocol ID
- 2-2010-0017
- Acronym
- BBP
- Status last verified
- Mar 2011
- First submitted
- 4 Apr 2011
- Last updated
- 19 Apr 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Botulinum Toxin Type A(Meditoxin®) on Sleep Bruxism by Different Injection Sites Evaluated by Polysomnography
- ClinicalTrials.gov ID
- NCT01336439
- Acronym / sponsor ID
- BBP / 2-2010-0017
- Conditions
- Sleep Bruxism
- Keywords
- Bruxism, Polysomnography, Botulinum toxin type A, Masseter muscle, Temporal muscle
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Aug 2011 (estimated)
- Study completion
- Dec 2011 (estimated)
- First posted
- 15 Apr 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the effect of Botulinum toxin type A(Meditoxin®) on bruxism using polysomnography and determine which site is most appropriate for injection to obtain maximal effects.
Detailed description
Bruxism is an oral habit consisting of involuntary non-functional gnashing, clenching, grinding of teeth and is a very common condition in the general population. Various treatment modalities such as occlusal splints, pharmacologic agent and cognitive-behavioral therapy have been investigated for the management of bruxism, but none is reported to be fully effective. Recently locally injected botulinum toxin has been used in various movement disorders, but its usefulness and objective effects on nocturnal bruxism have not been evaluated using objective measures such as polysomnography. Moreover, there is no systematic study about which site is most appropriate for injection to obtain maximal effects.
The aim of this study is to evaluate the effect of botulinum toxin type A into masseter muscle or both masseter muscle and temporal muscle on nocturnal bruxism using polysomnography and the changes in the bruxism events on polysomnography.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| M group | Active comparator | Drug: Botulinum toxin type A (Meditoxin®)A total of 25U of botulinum toxin type A was injected into each side masseter muscle in this arm. |
| MT group | Active comparator | Drug: Botulinum toxin type A (Meditoxin®)A total of 25U of botulinum toxin type A was injected into each side masseter and temporal muscle in this arm. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- clinical diagnosis of sleep bruxism confirmed by wear facets on occlusal splint
- must be able to follow clinical trial procedure
- who are suitable for this clinical trial
- who participated in this clinical trial out of his own free will
Key exclusion criteria (10 listed)
- who take medications such as benzodiazepine or muscle relaxants
- who have secondary bruxism due to brain injury
- who are pregnant or have the possibility of pregnancy
- who had an botulinum toxin injection during the past three months
- who had an allergic reaction history to botulinum toxin
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Botulinum toxin type A (Meditoxin®)Also: Meditoxin®(PacificPharm corporation, Korea)In this study, the botulinum toxin type A (Meditoxin®)was supplied as a freeze-dried powder of 200U, and was reconstituted with 4ml of sterile saline to a concentration of 5U/0.1ml. After pre-injection polysomnography, botulinum toxin type A was injected into each side bilaterally using a 1ml-syringe with a 29-gauge, and a 1/2-inch needle. The "M group" had an injection in masseter muscle. The "MT group" had an injection in masseter and temporal muscle. A total of 25U of botulinum toxin type A was injected into each site. After 4 weeks, the subjects had a post-injection polysomnography. | Drug | M group, MT group |
Primary outcome
The change of bruxism events
Time frame: At 4 weeks after Botulinum toxin type A injection
Before and after injection, we compared the change of bruxism event in polysomnography by sleep laboratory criteria. <Sleep laboratory criteria> - Mean SB EMG potential : >10% or 20% of the maximal clench while awake (masseter muscles) In M group, Botulinum toxin was injected into masseter muscle. In TM group, Botulinum toxin was injected into masseter muscle and temporal muscle.
4 secondary outcomes
The change of masticatory force(%)
Time frame: At 4 weeks after Botulinum toxin type A injection
The change of Pain
Time frame: At 4 weeks after Botulinum toxin type A injection
Sleep-related movement disorders
Time frame: At 4 weeks after Botulinum toxin type A injection
Sleep-related breathing disorders
Time frame: At 4 weeks after Botulinum toxin type A injection
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
SeongTaek Kim, PhD study chair
Yonsei University dental hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Botulinum toxin type A (Meditoxin®) in people with Sleep Bruxism, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact YoungJoo Shim, M.S.D. (82-2-2228-8875, yjshim@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change of bruxism events (time frame: At 4 weeks after Botulinum toxin type A injection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2011.