Nocturnal BruxismNCT05620316
The Use of Low-Dose Botulinum Toxin Injection Into the Masseter Muscle to Treat Sleep Bruxism
A study testing BOTOX® Injection and Prick skin in people with Nocturnal Bruxism, run by Damascus University at 1 site in Syria.
Trial summary
Botulinum toxin (BOTOX®) injections into the masseter muscle are an effective treatment for nocturnal bruxism, with several trials using various dosages of botulinum toxin for this purpose. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Nocturnal Bruxism
- What is being tested?
- BOTOX® Injection and Prick skin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteSyria
- Study dates
- 15 Mar 2021to 10 Feb 2022
- Phase
- Interventional
- 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 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Moderate to severe pain in the masseter muscles during clinical examination.
- Age range between 18 and 40 years.
- Tooth-grinding sounds corroborated by family members or caregivers.
- Attrition in occlusal surface of posterior teeth.
Who cannot join
- Loss two posterior teeth or more (except for third molars).
- Fixed or movable prosthodontics for more than four dental units.
- Advanced malocclusion (Class II occlusion Model II - deep bite - open bite).
- Temporomandibular disorders.
- Pain in the orofacial region.
- Insomnia.
Show all 12Show fewer
- Known botulinum toxin allergy.
- Pregnancy.
- Neuromuscular disease.
- Bleeding disorders.
- Antibiotic therapy, pulmonary disease that produced coughing during sleep.
- Infectious skin lesion at the site of the injection.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Efficacy of Low-Dose Botulinum Toxin Injection Into the Masseter Muscle for the Treatment of Nocturnal Bruxism: A Randomized Controlled Clinical Trial
Botulinum toxin (BOTOX®) injections into the masseter muscle are an effective treatment for nocturnal bruxism, with several trials using various dosages of botulinum toxin for this purpose. The aim was to evaluate the effectiveness of injecting 10MU of botulinum toxin A (BTXA) into the masseter muscle to reduce nocturnal bruxism, the sample will randomly divided into 2 groups.
In the injection group, Patients will inject with 10 MU of botulinum toxin type A (BOTOX® - Allergan Inc. - Dublin - Ireland) per side at two sites into the masseter muscle bilaterally.
Read more
In this Placebo group, patients will prick twice at the inferior prominent part of the masseter muscle observed using the stinger pen used in the blood glucose meter.
The evaluation will make by Electromyography (EMG) analysis, Visual Analogue Scale (VAS) values.
Read the detailed description
Nocturnal bruxism (NB) is a disorder of maxillomandibular activity characterized by nonfunctional grinding and clenching of teeth while sleeping.
NB can cause teeth attrition, dental prostheses/implant failure, tooth sensitivity, pain in the teeth, jaw, masticatory muscle, and temporomandibular joint (TMJ), neck pains and headache, periodontal disease, oral or facial pain, and perhaps tooth loss. The diagnosis of nocturnal bruxism is based on complaints of tooth grinding or clenching, as well as one or more of the following signs: nonfunctional teeth attrition, sounds consistent with bruxism, and jaw muscle discomfort. Teeth wear and TMJ dysfunction can both be caused by bruxism. In some circumstances, delaying therapy might lead to luxation and degenerative arthritis of the temporomandibular joint.
For the treatment of bruxism, many treatment approaches such as occlusal splints and pharmacologic medications such as psychobehavioral therapy or L-dopa, and psychobehavioral therapy have been examined but is not enough evidence to define a standard of reference approach for SB treatment.
Botulinum toxin (Botox®) is an exotoxin generated by the bacteria Clostridium botulinum that causes muscle inactivity by blocking acetylcholine release from cholinergic nerve terminals into the neuromuscular junction. In the last two decades, several studies have been conducted to investigate the efficacy of botulinum toxin type A (BTXA) in reducing nocturnal bruxism, and the results have been promising. These studies have used different doses of botulinum toxin ranging from 20 mouse units (MU) and 25 MU to 30 MU in the masseter. Most of these studies did not take into account the relationship between the amount of botulinum toxin dose and alteration of the masseter muscle's size and the shape of the lower third of the face, where injection of more than 20 MU into the masseter muscle affects its size and is an effective treatment for masseter muscle hypertrophy for at least 9 months. To avoid the unwanted side effects of doses greater than 20 MU, the trial aimed to evaluate the effectiveness of injecting 10 MU of the Botulinum toxin into the masseter muscle in reducing the nocturnal bruxism.
The idea of the research will explain to all patients, and the information sheets will distribute to them, then their consent will obtain.
- Conditions
- Nocturnal Bruxism
- Being tested
- BOTOX® Injection, Prick skin
- Keywords
- Nocturnal bruxism, Botulinum toxin, Masseter muscle, Electromyography
- Medical subject headings
- Sleep Bruxism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BOTOX® InjectionDrug
100 MU of botulinum toxin type A (BOTOX® - Allergan Inc. - Dublin - Ireland) were diluted in 2ml of saline. Patients were injected with 10 MU of BTXA per side at two sites into the masseter muscle bilaterally. The first site was the inferior prominent part of the masseter muscle observed when the subject was asked to clench, and the other site was 5 mm below the first point
Prick skinOther
patients were pricked twice at the inferior prominent part of the masseter muscle observed using the stinger pen used in the blood glucose meter; it is less painful and provides psychological benefits, instead of injecting the physiological saline into the muscle to avoid the severe pain without a benefit to the patient which would not conform to the ethical standards.
| Study group | Role | What they receive |
|---|---|---|
| Injection group | Experimental | In this group, patients will be injected with 10 MU of botulinum toxin type A in the masseter muscle. Receives: Drug: BOTOX® Injection |
| Placebo group | Placebo comparator | In this group, patients will prick twice in the masseter muscle. Receives: Other: Prick skin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the electromyographic recorded values
EMG signals will record with Matrix EP Light EMG (Micromed, Via Giotto, Mogliano Veneto, Italy) with four channels. The recorded signals will amplify sampled at 1024 Hz, and the acquired data will analyze with System Plus Evaluation software (Micromed, Via Giotto, Mogliano Veneto, Italy).
The acquisitions will perform twice with the rest position of the mandible (RPM) for 10 seconds, in maximal intercuspal position (MIP) for five seconds and maximal teeth clenching (MTC) with 10-mm thick cotton rolls between the posterior teeth for five seconds, bilaterally, and the values obtained will be averaged.
Measured: Assessment will be done before the injection (T0) and then at 2 weeks (T1), 3 months (T2), and 6 months after the injection (T3)
Change in the perception of pain
A visual analog scale (VAS) will be used for this assessment. A line of 100 mm in length will be used, and the patient will ask to put a mark on the line that reflects her/his perceived pain; the scores of the scale will be determined by measuring the distance in mm from the beginning to the point indicated by the patient (point (0): no pain and point (100): the highest levels of pain).
Measured: Assessment will be done before the injection (T0) and then at 2 weeks (T1), 3 months (T2), and 6 months after the injection (T3)
Secondary outcomes (2)
Time to first observation of positive effects
The mean time that the effects were first seen will be recorded.
Measured: 2 week
Loss of effectiveness and side effects
The mean time at which the loss of effectiveness started seen will be recorded.
Measured: 4 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2022
- Study start15 Mar 2021
- Primary completion15 Sep 2021
- Study completion10 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Nocturnal BruxismStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Damascus University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zaed Ghassan Shehri, DDS, Principal investigator, Department of Maxillofacial and oral surgery, Damascus University, Syria.Issam Alkhouri, DDS,MSc,PhD, Study director, Department of Maxillofacial and oral surgery, Damascus University, Syria.Ibrahim Haddad, MSc,PhD, Study director, Department of Basic Sciences, Damascus University, Syria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05620316
- Sponsor's protocol ID
- UDDS-OMFS-02-2022
- Status last verified
- Nov 2022
- First submitted
- 5 Nov 2022
- Last updated
- 17 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Manfredini D, Ahlberg J, Winocur E, Lobbezoo F. Management of sleep bruxism in adults: a qualitative systematic literature review. J Oral Rehabil. 2015 Nov;42(11):862-74. doi: 10.1111/joor.12322. Epub 2015 Jun 11.
PubMed 26095208Carra MC, Huynh N, Lavigne G. Sleep bruxism: a comprehensive overview for the dental clinician interested in sleep medicine. Dent Clin North Am. 2012 Apr;56(2):387-413. doi: 10.1016/j.cden.2012.01.003.
PubMed 22480810Lavigne GJ, Khoury S, Abe S, Yamaguchi T, Raphael K. Bruxism physiology and pathology: an overview for clinicians. J Oral Rehabil. 2008 Jul;35(7):476-94. doi: 10.1111/j.1365-2842.2008.01881.x.
PubMed 18557915Lobbezoo F, Ahlberg J, Glaros AG, Kato T, Koyano K, Lavigne GJ, de Leeuw R, Manfredini D, Svensson P, Winocur E. Bruxism defined and graded: an international consensus. J Oral Rehabil. 2013 Jan;40(1):2-4. doi: 10.1111/joor.12011. Epub 2012 Nov 4.
PubMed 23121262Sellin LC, Thesleff S. Pre- and post-synaptic actions of botulinum toxin at the rat neuromuscular junction. J Physiol. 1981 Aug;317:487-95. doi: 10.1113/jphysiol.1981.sp013838.
PubMed 6273549Tan EK, Jankovic J. Treating severe bruxism with botulinum toxin. J Am Dent Assoc. 2000 Feb;131(2):211-6. doi: 10.14219/jada.archive.2000.0149.
PubMed 10680389
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy of Low-Dose Botulinum Toxin Injection Into the Masseter Muscle for the Treatment of Nocturnal Bruxism: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT05620316
- Acronym / sponsor ID
- UDDS-OMFS-02-2022
- Conditions
- Nocturnal Bruxism
- Keywords
- Nocturnal bruxism, Botulinum toxin, Masseter muscle, Electromyography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Damascus UniversityUniversity, hospital or other
- Study start
- 15 Mar 2021 (actual)
- Primary completion
- 15 Sep 2021 (actual)
- Study completion
- 10 Feb 2022 (actual)
- First posted
- 17 Nov 2022 (actual)
- 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.
Botulinum toxin (BOTOX®) injections into the masseter muscle are an effective treatment for nocturnal bruxism, with several trials using various dosages of botulinum toxin for this purpose. The aim was to evaluate the effectiveness of injecting 10MU of botulinum toxin A (BTXA) into the masseter muscle to reduce nocturnal bruxism, the sample will randomly divided into 2 groups.
In the injection group, Patients will inject with 10 MU of botulinum toxin type A (BOTOX® - Allergan Inc. - Dublin - Ireland) per side at two sites into the masseter muscle bilaterally.
In this Placebo group, patients will prick twice at the inferior prominent part of the masseter muscle observed using the stinger pen used in the blood glucose meter.
The evaluation will make by Electromyography (EMG) analysis, Visual Analogue Scale (VAS) values.
Detailed description
Nocturnal bruxism (NB) is a disorder of maxillomandibular activity characterized by nonfunctional grinding and clenching of teeth while sleeping.
NB can cause teeth attrition, dental prostheses/implant failure, tooth sensitivity, pain in the teeth, jaw, masticatory muscle, and temporomandibular joint (TMJ), neck pains and headache, periodontal disease, oral or facial pain, and perhaps tooth loss. The diagnosis of nocturnal bruxism is based on complaints of tooth grinding or clenching, as well as one or more of the following signs: nonfunctional teeth attrition, sounds consistent with bruxism, and jaw muscle discomfort. Teeth wear and TMJ dysfunction can both be caused by bruxism. In some circumstances, delaying therapy might lead to luxation and degenerative arthritis of the temporomandibular joint.
For the treatment of bruxism, many treatment approaches such as occlusal splints and pharmacologic medications such as psychobehavioral therapy or L-dopa, and psychobehavioral therapy have been examined but is not enough evidence to define a standard of reference approach for SB treatment.
Botulinum toxin (Botox®) is an exotoxin generated by the bacteria Clostridium botulinum that causes muscle inactivity by blocking acetylcholine release from cholinergic nerve terminals into the neuromuscular junction. In the last two decades, several studies have been conducted to investigate the efficacy of botulinum toxin type A (BTXA) in reducing nocturnal bruxism, and the results have been promising. These studies have used different doses of botulinum toxin ranging from 20 mouse units (MU) and 25 MU to 30 MU in the masseter. Most of these studies did not take into account the relationship between the amount of botulinum toxin dose and alteration of the masseter muscle's size and the shape of the lower third of the face, where injection of more than 20 MU into the masseter muscle affects its size and is an effective treatment for masseter muscle hypertrophy for at least 9 months. To avoid the unwanted side effects of doses greater than 20 MU, the trial aimed to evaluate the effectiveness of injecting 10 MU of the Botulinum toxin into the masseter muscle in reducing the nocturnal bruxism.
The idea of the research will explain to all patients, and the information sheets will distribute to them, then their consent will obtain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Injection group | Experimental | Drug: BOTOX® InjectionIn this group, patients will be injected with 10 MU of botulinum toxin type A in the masseter muscle. |
| Placebo group | Placebo comparator | Other: Prick skinIn this group, patients will prick twice in the masseter muscle. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Moderate to severe pain in the masseter muscles during clinical examination.
- Age range between 18 and 40 years.
- Tooth-grinding sounds corroborated by family members or caregivers.
- Attrition in occlusal surface of posterior teeth.
Key exclusion criteria (12 listed)
- Loss two posterior teeth or more (except for third molars).
- Fixed or movable prosthodontics for more than four dental units.
- Advanced malocclusion (Class II occlusion Model II - deep bite - open bite).
- Temporomandibular disorders.
- Pain in the orofacial region.
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 |
|---|---|---|
| BOTOX® Injection100 MU of botulinum toxin type A (BOTOX® - Allergan Inc. - Dublin - Ireland) were diluted in 2ml of saline. Patients were injected with 10 MU of BTXA per side at two sites into the masseter muscle bilaterally. The first site was the inferior prominent part of the masseter muscle observed when the subject was asked to clench, and the other site was 5 mm below the first point | Drug | Injection group |
| Prick skinpatients were pricked twice at the inferior prominent part of the masseter muscle observed using the stinger pen used in the blood glucose meter; it is less painful and provides psychological benefits, instead of injecting the physiological saline into the muscle to avoid the severe pain without a benefit to the patient which would not conform to the ethical standards. | Other | Placebo group |
Primary outcome
Change in the electromyographic recorded values
Time frame: Assessment will be done before the injection (T0) and then at 2 weeks (T1), 3 months (T2), and 6 months after the injection (T3)
EMG signals will record with Matrix EP Light EMG (Micromed, Via Giotto, Mogliano Veneto, Italy) with four channels. The recorded signals will amplify sampled at 1024 Hz, and the acquired data will analyze with System Plus Evaluation software (Micromed, Via Giotto, Mogliano Veneto, Italy). The acquisitions will perform twice with the rest position of the mandible (RPM) for 10 seconds, in maximal intercuspal position (MIP) for five seconds and maximal teeth clenching (MTC) with 10-mm thick cotton rolls between the posterior teeth for five seconds, bilaterally, and the values obtained will be averaged.
Change in the perception of pain
Time frame: Assessment will be done before the injection (T0) and then at 2 weeks (T1), 3 months (T2), and 6 months after the injection (T3)
A visual analog scale (VAS) will be used for this assessment. A line of 100 mm in length will be used, and the patient will ask to put a mark on the line that reflects her/his perceived pain; the scores of the scale will be determined by measuring the distance in mm from the beginning to the point indicated by the patient (point (0): no pain and point (100): the highest levels of pain).
2 secondary outcomes
Time to first observation of positive effects
Time frame: 2 week
Loss of effectiveness and side effects
Time frame: 4 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2022.
- Background: PubMed 26095208Manfredini D, Ahlberg J, Winocur E, Lobbezoo F. Management of sleep bruxism in adults: a qualitative systematic literature review. J Oral Rehabil. 2015 Nov;42(11):862-74. doi: 10.1111/joor.12322. Epub 2015 Jun 11.
- Background: PubMed 22480810Carra MC, Huynh N, Lavigne G. Sleep bruxism: a comprehensive overview for the dental clinician interested in sleep medicine. Dent Clin North Am. 2012 Apr;56(2):387-413. doi: 10.1016/j.cden.2012.01.003.
- Background: PubMed 18557915Lavigne GJ, Khoury S, Abe S, Yamaguchi T, Raphael K. Bruxism physiology and pathology: an overview for clinicians. J Oral Rehabil. 2008 Jul;35(7):476-94. doi: 10.1111/j.1365-2842.2008.01881.x.
- Background: PubMed 23121262Lobbezoo F, Ahlberg J, Glaros AG, Kato T, Koyano K, Lavigne GJ, de Leeuw R, Manfredini D, Svensson P, Winocur E. Bruxism defined and graded: an international consensus. J Oral Rehabil. 2013 Jan;40(1):2-4. doi: 10.1111/joor.12011. Epub 2012 Nov 4.
- Background: PubMed 6273549Sellin LC, Thesleff S. Pre- and post-synaptic actions of botulinum toxin at the rat neuromuscular junction. J Physiol. 1981 Aug;317:487-95. doi: 10.1113/jphysiol.1981.sp013838.
- Background: PubMed 10680389Tan EK, Jankovic J. Treating severe bruxism with botulinum toxin. J Am Dent Assoc. 2000 Feb;131(2):211-6. doi: 10.14219/jada.archive.2000.0149.
- Individual participant dataSharing planned: No
Related trials for Nocturnal Bruxism
RecruitingObservational study
Orofacial Pain and Oral Health-Related Quality of Life in Musicians in German Amateur Orchestras
Orofacial Pain, Sleep Bruxism
Not yet recruitingObservational study
Bruxism Induced by Obstructive Sleep Apnoea.
Sleep Apnea Syndrome, Obstructive, Bruxism, Sleep-Related
Enrolling by invitationObservational study
Relationship Between Selected Parameters and Bruxism
Sleep Bruxism, Sleep Disorder
Active, not recruiting
Effect of Marjoram, Vetiver, and Lavender Oil in the Treatment of Bruxism
Bruxism, Bruxism, Sleep
Recruiting
Bruxism Therapy of Facial Pain
Bruxism, Bruxism, Sleep-Related
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.
Zaed Ghassan Shehri, DDS principal investigator
Department of Maxillofacial and oral surgery, Damascus University, Syria.
Issam Alkhouri, DDS,MSc,PhD study director
Department of Maxillofacial and oral surgery, Damascus University, Syria.
Ibrahim Haddad, MSc,PhD study director
Department of Basic Sciences, Damascus University, Syria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BOTOX® Injection and Prick skin in people with Nocturnal Bruxism, run by Damascus University at 1 site in Syria.
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 12 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: finished, as of the sponsor's last update on 17 Nov 2022. 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 Syria. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the electromyographic recorded values (time frame: Assessment will be done before the injection (T0) and then at 2 weeks (T1), 3 months (T2), and 6 months after the injection (T3)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05620316, which also lists 6 linked publications.
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 17 Nov 2022.