BruxismNCT07266064
Repeated Botulinum Toxin Type A Injections on Intramuscular Fat Accumulation in Individuals With Sleep Bruxism.
A study testing Botilinum Toxin injection in people with Bruxism and Bruxism, Sleep, run by Melek Volkan Yazici at 1 site in Turkey (Türkiye).
Trial summary
This study investigates whether repeated botulinum toxin type A (BoNT-A) injections used to manage sleep bruxism lead to structural changes-specifically intramuscular fat accumulation-in the masseter muscle. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bruxism, Bruxism, Sleep, Bruxism, Sleep-Related
- What is being tested?
- Botilinum Toxin injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Jan 2024to 20 Nov 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18 years or older.
- Clinical diagnosis of probable sleep bruxism according to the international consensus criteria proposed by Lobbezoo et al.
- Indication for BoNT-A injection in the masseter muscle due to bruxism-related pain or muscle hypertrophy.
- Willingness to undergo repeated BoNT-A injections at six-month intervals.
- Willingness to participate in ultrasonographic evaluations at each follow-up visit.
Who cannot join
- Presence of neurological or neuromuscular disorders affecting the masticatory muscles (e.g., dystonia, myasthenia gravis).
- History of orofacial trauma, temporomandibular joint dysfunction, or maxillofacial surgery.
- Systemic diseases that may affect neuromuscular transmission or muscle metabolism.
- Use of medications known to interfere with neuromuscular function, including aminoglycoside antibiotics or corticosteroids.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara University, Faculty of Dentistry
Ankara, Cankaya, 06560
About this study
Official title: Repeated Botulinum Toxin Type A Injections on the Masseter Muscle of Individuals With Sleep Bruxism: A Longitudinal Ultrasonographic Study.
This study investigates whether repeated botulinum toxin type A (BoNT-A) injections used to manage sleep bruxism lead to structural changes-specifically intramuscular fat accumulation-in the masseter muscle. Adults with probable sleep bruxism receive BoNT-A injections every six months and undergo ultrasound evaluations before each injection. By tracking fat percentage in the masseter muscle over multiple treatment cycles, the study aims to determine whether long-term BoNT-A use causes progressive structural alterations or remains safe for repeated clinical use.
Read the detailed description
Botulinum toxin type A (BoNT-A) is commonly used for the management of sleep bruxism, yet concerns persist regarding its long-term effects on muscle structure, including the possibility of intramuscular fat accumulation in the masseter muscle. This prospective longitudinal study follows adults with probable sleep bruxism who receive bilateral BoNT-A injections at six-month intervals. Ultrasound imaging is performed immediately before each injection, resulting in four injection cycles and five standardized ultrasound assessments.
Intramuscular fat percentage is quantified from B-mode images at rest and during maximum voluntary contraction using binary segmentation techniques. By examining changes over repeated treatment cycles, the study evaluates whether BoNT-A leads to progressive fat infiltration or instead demonstrates a stable or adaptive pattern. Findings will help clarify the structural safety of long-term BoNT-A use in non-spastic masticatory muscles and guide clinical decision-making for ongoing bruxism management.
- Conditions
- Bruxism, Bruxism, Sleep, Bruxism, Sleep-Related
- Being tested
- Botilinum Toxin injection
- Keywords
- Botulinum Toxin Type A, Bruxism, Masseter Muscle, Ultrasonography, Adipose Tissue, Longitudinal Study
- Medical subject headings
- Bruxism, Sleep Bruxism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Botilinum Toxin injectionOther
This prospective longitudinal interventional study included adults with probable sleep bruxism who received bilateral BoNT-A injections every six months, with ultrasonographic assessments also performed at six-month intervals, immediately before each new injection. The protocol therefore comprised four injection cycles and five ultrasound sessions. Ultrasonographic evaluations were conducted before the first injection and six months after each subsequent injection to quantify intramuscular fat percentage at rest and during maximum voluntary contraction. Fat area percentage was computed from standardized B-mode images using binary segmentation in CT-Analyzer software.
| Study group | Role | What they receive |
|---|---|---|
| BoNT-A | Experimental | At baseline, all participants underwent ultrasonographic evaluation of both masseter muscles (U0). Two weeks later, the first BoNT-A injection was administered bilaterally (U1). Thereafter, ultrasonography was repeated at six-month intervals (U1-U4). Each of the intermediate assessments was followed by a BoNT-A injection two weeks later (U2-U4), whereas the final assessment (U4) was not followed by injection. Thus, the protocol comprised five ultrasound sessions (U0-U4) and four BoNT-A sessions (U1-U4), unless the participant discontinued the study. All ultrasound examinations were performed by the same experienced examiner using the same device and standardized probe settings. Receives: Other: Botilinum Toxin injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ultrasonographic imaging
Cross-sectional imaging was obtained from the same anatomical plane. The probe position was determined at each visit using consistent anatomical landmarks-specifically the lower border of the mandibular corpus and the thickest region of the masseter muscle. The imaging plane part of the masseter, located between the posterior border adjacent to the parotid gland and the anterior border of the mandibular ramus. Ultrasonographic images were acquired both at rest (RST) and during maximum voluntary contraction (MVC) under identical device settings by the same experienced radiologist.
Measured: From enrollment to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2025
- Study start2 Jan 2024
- Primary completion20 Nov 2025
- Study completion20 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective, longitudinal study.
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Melek Volkan Yazici
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Melek Volkan Yazici, Yuksek Ihtisas University
- Investigators
- GOKHAN YAZICI, A/Prof, Study chair, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07266064
- Sponsor's protocol ID
- Botox series
- Status last verified
- Dec 2025
- First submitted
- 22 Nov 2025
- Last updated
- 5 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Due to ethical and confidentiality considerations, the dataset generated and/or analyzed during the current study is not publicly available. However, data may be made available from the corresponding author upon reasonable request and subject to institutional approval.
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Repeated Botulinum Toxin Type A Injections on the Masseter Muscle of Individuals With Sleep Bruxism: A Longitudinal Ultrasonographic Study.
- ClinicalTrials.gov ID
- NCT07266064
- Acronym / sponsor ID
- Botox series
- Conditions
- Bruxism, Bruxism, Sleep, Bruxism, Sleep-Related
- Keywords
- Botulinum Toxin Type A, Bruxism, Masseter Muscle, Ultrasonography, Adipose Tissue, Longitudinal Study
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Melek Volkan YaziciUniversity, hospital or other
- Study start
- 2 Jan 2024 (actual)
- Primary completion
- 20 Nov 2025 (actual)
- Study completion
- 20 Nov 2025 (actual)
- First posted
- 5 Dec 2025 (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.
This study investigates whether repeated botulinum toxin type A (BoNT-A) injections used to manage sleep bruxism lead to structural changes-specifically intramuscular fat accumulation-in the masseter muscle. Adults with probable sleep bruxism receive BoNT-A injections every six months and undergo ultrasound evaluations before each injection. By tracking fat percentage in the masseter muscle over multiple treatment cycles, the study aims to determine whether long-term BoNT-A use causes progressive structural alterations or remains safe for repeated clinical use.
Detailed description
Botulinum toxin type A (BoNT-A) is commonly used for the management of sleep bruxism, yet concerns persist regarding its long-term effects on muscle structure, including the possibility of intramuscular fat accumulation in the masseter muscle. This prospective longitudinal study follows adults with probable sleep bruxism who receive bilateral BoNT-A injections at six-month intervals. Ultrasound imaging is performed immediately before each injection, resulting in four injection cycles and five standardized ultrasound assessments.
Intramuscular fat percentage is quantified from B-mode images at rest and during maximum voluntary contraction using binary segmentation techniques. By examining changes over repeated treatment cycles, the study evaluates whether BoNT-A leads to progressive fat infiltration or instead demonstrates a stable or adaptive pattern. Findings will help clarify the structural safety of long-term BoNT-A use in non-spastic masticatory muscles and guide clinical decision-making for ongoing bruxism management.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective, longitudinal study.
| Arm | Type | Receives |
|---|---|---|
| BoNT-A | Experimental | Other: Botilinum Toxin injectionAt baseline, all participants underwent ultrasonographic evaluation of both masseter muscles (U0). Two weeks later, the first BoNT-A injection was administered bilaterally (U1). Thereafter, ultrasonography was repeated at six-month intervals (U1-U4). Each of the intermediate assessments was followed by a BoNT-A injection two weeks later (U2-U4), whereas the final assessment (U4) was not followed by injection. Thus, the protocol comprised five ultrasound sessions (U0-U4) and four BoNT-A sessions (U1-U4), unless the participant discontinued the study. All ultrasound examinations were performed by the same experienced examiner using the same device and standardized probe settings. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults aged 18 years or older.
- Clinical diagnosis of probable sleep bruxism according to the international consensus criteria proposed by Lobbezoo et al.
- Indication for BoNT-A injection in the masseter muscle due to bruxism-related pain or muscle hypertrophy.
- Willingness to undergo repeated BoNT-A injections at six-month intervals.
- Willingness to participate in ultrasonographic evaluations at each follow-up visit.
Key exclusion criteria (4 listed)
- Presence of neurological or neuromuscular disorders affecting the masticatory muscles (e.g., dystonia, myasthenia gravis).
- History of orofacial trauma, temporomandibular joint dysfunction, or maxillofacial surgery.
- Systemic diseases that may affect neuromuscular transmission or muscle metabolism.
- Use of medications known to interfere with neuromuscular function, including aminoglycoside antibiotics or corticosteroids.
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 |
|---|---|---|
| Botilinum Toxin injectionThis prospective longitudinal interventional study included adults with probable sleep bruxism who received bilateral BoNT-A injections every six months, with ultrasonographic assessments also performed at six-month intervals, immediately before each new injection. The protocol therefore comprised four injection cycles and five ultrasound sessions. Ultrasonographic evaluations were conducted before the first injection and six months after each subsequent injection to quantify intramuscular fat percentage at rest and during maximum voluntary contraction. Fat area percentage was computed from standardized B-mode images using binary segmentation in CT-Analyzer software. | Other | BoNT-A |
Primary outcome
Ultrasonographic imaging
Time frame: From enrollment to 6 months
Cross-sectional imaging was obtained from the same anatomical plane. The probe position was determined at each visit using consistent anatomical landmarks-specifically the lower border of the mandibular corpus and the thickest region of the masseter muscle. The imaging plane part of the masseter, located between the posterior border adjacent to the parotid gland and the anterior border of the mandibular ramus. Ultrasonographic images were acquired both at rest (RST) and during maximum voluntary contraction (MVC) under identical device settings by the same experienced radiologist.
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 5 Dec 2025.
- Individual participant dataSharing planned: No. Due to ethical and confidentiality considerations, the dataset generated and/or analyzed during the current study is not publicly available. However, data may be made available from the corresponding author upon reasonable request and subject to institutional approval.
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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.
GOKHAN YAZICI, A/Prof study chair
Gazi University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Botilinum Toxin injection in people with Bruxism and Bruxism, Sleep, run by Melek Volkan Yazici at 1 site in Turkey (Türkiye).
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 5 inclusion and 4 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 5 Dec 2025. 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 Turkey (Türkiye). 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.
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?
Ultrasonographic imaging (time frame: From enrollment to 6 months). 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 5 Dec 2025.