BruxismNCT07545200
Ultrasonographic Evaluation of Masseter Muscle Changes After Botulinum Toxin Injection in Bruxism Patients
A study testing Botulinum Toxin A (Botox ) in people with Bruxism and Myofascial Pain, run by Kahramanmaras Sutcu Imam University at 1 site in Turkey (Türkiye).
Trial summary
This prospective pilot study aimed to evaluate short-term clinical and ultrasonographic changes in the masseter muscle following botulinum toxin injection in patients with bruxism. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Bruxism, Myofascial Pain, Masseter Muscle Hypertrophy
- What is being tested?
- Botulinum Toxin A (Botox )
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Sep 2025to 15 Feb 2026
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adults aged 18-60 years Clinically diagnosed with bruxism Scheduled for botulinum toxin injection into the masseter muscle Willing to participate and provided written informed consent Completed all follow-up visits (baseline, Day 14, and Day 90)
Who cannot join
- Previous botulinum toxin injection to the masseter muscle Presence of neuromuscular disorders affecting masticatory muscles History of temporomandibular joint surgery Pregnancy or breastfeeding Presence of trauma, infection, or mass in the masseter region Any condition that may interfere with ultrasonographic evaluation Failure to complete follow-up visits
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kahramanmaras Sutcu Imam University
Kahramanmaraş, Choose A State, 46000
About this study
Official title: Quantitative Ultrasonographic Assessment of Masseter Muscle Changes Following Botulinum Toxin Injection in Patients With Bruxism: A Prospective Pilot Study
This prospective pilot study aimed to evaluate short-term clinical and ultrasonographic changes in the masseter muscle following botulinum toxin injection in patients with bruxism. Clinical assessments included pain evaluation using the Visual Analog Scale (VAS), while ultrasonographic evaluation included measurement of masseter muscle thickness and quantitative texture analysis using fractal dimension and histogram parameters. Measurements were performed at baseline, 14 days, and 90 days after treatment. The study aimed to assess both macroscopic and microstructural changes in the muscle tissue.
Read the detailed description
This study investigated the short-term effects of botulinum toxin injection on the masseter muscle in patients with bruxism using quantitative ultrasonographic methods. All participants received bilateral botulinum toxin injections into the masseter muscle using a standardized technique. Ultrasonographic examinations were performed using a high-frequency linear probe. Masseter muscle thickness was measured at a standardized anatomical location during maximal clenching.
For quantitative texture analysis, a fixed-size region of interest (ROI) was placed in the central intramuscular portion of the masseter muscle while avoiding fascia, bone, and artifacts. Fractal analysis was performed using the box-counting method to assess structural complexity, while histogram analysis was used to evaluate grayscale pixel distribution reflecting echotexture characteristics.
Clinical and ultrasonographic measurements were recorded at baseline, 14 days, and 90 days post-injection. The study aimed to determine whether botulinum toxin induces not only functional and morphological changes but also microstructural alterations in muscle tissue.
- Conditions
- Bruxism, Myofascial Pain, Masseter Muscle Hypertrophy
- Being tested
- Botulinum Toxin A (Botox )
- Keywords
- bruxism, Botulinum Toxin A, Masseter Muscle, Ultrasonography, Muscle Thickness, Fractal Analysis, Histogram Analysis
- Medical subject headings
- Bruxism, Masticatory Muscles, Hypertrophy of
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Botulinum Toxin A (Botox )Drug
Botulinum toxin A was injected bilaterally into the masseter muscle using a standardized injection protocol. Injections were administered at three points in the most prominent region of the muscle. Clinical and ultrasonographic evaluations were performed at baseline, 14 days, and 90 days after injection.
| Study group | Role | What they receive |
|---|---|---|
| Botulinum Toxin Group | Experimental | Participants received bilateral botulinum toxin injections into the masseter muscle using a standardized injection protocol. Clinical and ultrasonographic assessments were performed at baseline, 14 days, and 90 days post-treatment. Receives: Drug: Botulinum Toxin A (Botox ) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Masseter Muscle Thickness
Change in masseter muscle thickness measured in millimeters using ultrasonography at baseline, 14 days, and 90 days following botulinum toxin injection.
Measured: Baseline, Day 14, Day 90
Secondary outcomes (3)
Pain Intensity (VAS Score)
Change in pain intensity measured using the Visual Analog Scale (VAS) ranging from 0 (no pain) to 10 (worst imaginable pain) at baseline, 14 days, and 90 days after botulinum toxin injection.
Measured: Baseline, Day 14, Day 90
Fractal Dimension of Masseter Muscle
Change in fractal dimension values derived from ultrasonographic images using region-of-interest (ROI)-based analysis to assess microstructural complexity at baseline, 14 days, and 90 days post-intervention.
Measured: Baseline, Day 14, Day 90
Ultrasound Echotexture (Histogram Analysis)
Change in grayscale histogram parameters obtained from ultrasound images of the masseter muscle, reflecting echotexture characteristics, at baseline, 14 days, and 90 days after treatment.
Measured: Baseline, Day 14, Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2026
- Study start30 Sep 2025
- Primary completion15 Feb 2026
- Study completion15 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single-group, non-randomized interventional study in which all participants received bilateral botulinum toxin injections into the masseter muscle. Outcomes were assessed longitudinally at baseline, 14 days, and 90 days post-intervention. Each participant served as their own control.
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kahramanmaras Sutcu Imam University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, AYŞE GÜL ÖNER TALMAÇ, Kahramanmaras Sutcu Imam University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07545200
- Sponsor's protocol ID
- MasseterMuscle
- Status last verified
- Apr 2026
- First submitted
- 16 Apr 2026
- Last updated
- 22 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Oner Talmac AG, Balkanlioglu AC. Short-term quantitative ultrasonographic assessment of masseter muscle changes following botulinum toxin injection in patients with bruxism: A prospective pilot study. Cranio. 2026 Aug 11:1-11. doi: 10.1080/08869634.2026.2715421. Online ahead of print.
PubMed 42579291
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantitative Ultrasonographic Assessment of Masseter Muscle Changes Following Botulinum Toxin Injection in Patients With Bruxism: A Prospective Pilot Study
- ClinicalTrials.gov ID
- NCT07545200
- Acronym / sponsor ID
- MasseterMuscle
- Conditions
- Bruxism, Myofascial Pain, Masseter Muscle Hypertrophy
- Keywords
- bruxism, Botulinum Toxin A, Masseter Muscle, Ultrasonography, Muscle Thickness, Fractal Analysis, Histogram Analysis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Kahramanmaras Sutcu Imam UniversityUniversity, hospital or other
- Study start
- 30 Sep 2025 (actual)
- Primary completion
- 15 Feb 2026 (actual)
- Study completion
- 15 Feb 2026 (actual)
- First posted
- 22 Apr 2026 (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 prospective pilot study aimed to evaluate short-term clinical and ultrasonographic changes in the masseter muscle following botulinum toxin injection in patients with bruxism. Clinical assessments included pain evaluation using the Visual Analog Scale (VAS), while ultrasonographic evaluation included measurement of masseter muscle thickness and quantitative texture analysis using fractal dimension and histogram parameters. Measurements were performed at baseline, 14 days, and 90 days after treatment. The study aimed to assess both macroscopic and microstructural changes in the muscle tissue.
Detailed description
This study investigated the short-term effects of botulinum toxin injection on the masseter muscle in patients with bruxism using quantitative ultrasonographic methods. All participants received bilateral botulinum toxin injections into the masseter muscle using a standardized technique. Ultrasonographic examinations were performed using a high-frequency linear probe. Masseter muscle thickness was measured at a standardized anatomical location during maximal clenching.
For quantitative texture analysis, a fixed-size region of interest (ROI) was placed in the central intramuscular portion of the masseter muscle while avoiding fascia, bone, and artifacts. Fractal analysis was performed using the box-counting method to assess structural complexity, while histogram analysis was used to evaluate grayscale pixel distribution reflecting echotexture characteristics.
Clinical and ultrasonographic measurements were recorded at baseline, 14 days, and 90 days post-injection. The study aimed to determine whether botulinum toxin induces not only functional and morphological changes but also microstructural alterations in muscle tissue.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-group, non-randomized interventional study in which all participants received bilateral botulinum toxin injections into the masseter muscle. Outcomes were assessed longitudinally at baseline, 14 days, and 90 days post-intervention. Each participant served as their own control.
| Arm | Type | Receives |
|---|---|---|
| Botulinum Toxin Group | Experimental | Drug: Botulinum Toxin A (Botox )Participants received bilateral botulinum toxin injections into the masseter muscle using a standardized injection protocol. Clinical and ultrasonographic assessments were performed at baseline, 14 days, and 90 days post-treatment. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Adults aged 18-60 years Clinically diagnosed with bruxism Scheduled for botulinum toxin injection into the masseter muscle Willing to participate and provided written informed consent Completed all follow-up visits (baseline, Day 14, and Day 90)
Key exclusion criteria (1 listed)
- Previous botulinum toxin injection to the masseter muscle Presence of neuromuscular disorders affecting masticatory muscles History of temporomandibular joint surgery Pregnancy or breastfeeding Presence of trauma, infection, or mass in the masseter region Any condition that may interfere with ultrasonographic evaluation Failure to complete follow-up visits
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 A (Botox )Botulinum toxin A was injected bilaterally into the masseter muscle using a standardized injection protocol. Injections were administered at three points in the most prominent region of the muscle. Clinical and ultrasonographic evaluations were performed at baseline, 14 days, and 90 days after injection. | Drug | Botulinum Toxin Group |
Primary outcome
Masseter Muscle Thickness
Time frame: Baseline, Day 14, Day 90
Change in masseter muscle thickness measured in millimeters using ultrasonography at baseline, 14 days, and 90 days following botulinum toxin injection.
3 secondary outcomes
Pain Intensity (VAS Score)
Time frame: Baseline, Day 14, Day 90
Fractal Dimension of Masseter Muscle
Time frame: Baseline, Day 14, Day 90
Ultrasound Echotexture (Histogram Analysis)
Time frame: Baseline, Day 14, Day 90
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 22 Apr 2026.
- Derived from this study: PubMed 42579291Oner Talmac AG, Balkanlioglu AC. Short-term quantitative ultrasonographic assessment of masseter muscle changes following botulinum toxin injection in patients with bruxism: A prospective pilot study. Cranio. 2026 Aug 11:1-11. doi: 10.1080/08869634.2026.2715421. Online ahead of print.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Botulinum Toxin A (Botox ) in people with Bruxism and Myofascial Pain, run by Kahramanmaras Sutcu Imam University 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 1 inclusion and 1 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 22 Apr 2026. 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?
Masseter Muscle Thickness (time frame: Baseline, Day 14, Day 90). 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 NCT07545200, which also lists 1 linked publication.
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 22 Apr 2026.