Awake Bruxism, Bruxism, Masseter Muscle Hypertrophy, Sleep Bruxism, Adult, Temporomandibular Disorders
Conditions
Keywords
Bruxism, Botulinum Toxins, Type A, Dry Needling, Masseter Muscle, Temporal Muscle, Ultrasonography
Brief summary
1. Aim: The aim of this study is to prospectively compare the clinical efficacy of Dry Needling (DN), Nabota (PrabotulinumtoxinA), and Dysport (AbobotulinumtoxinA) treatments on the thickness of masseter and anterior temporal muscles and pain intensity (VAS) in patients diagnosed with chronic bruxism. 2. Material and Method: This randomized, prospective, and single-blind clinical study will be conducted on 60 patients diagnosed with bruxism. Patients will be divided into three groups: Dry Needling (n=20), Nabota (n=20), and Dysport (n=20). Pain levels will be assessed using the Visual Analog Scale (VAS) at baseline, 1st month, and 3rd month. Muscle thicknesses will be measured using ultrasonography (USG) at baseline and 3rd month. Data distribution will be analyzed using the Kolmogorov-Smirnov test; intergroup comparisons will be performed using ANOVA and Post-hoc Duncan tests. 3. Results:The results will be analyzed following the completion of the 3-month follow-up period
Interventions
Injection of AbobotulinumtoxinA. A total of 500 Units (reconstituted to approximately 167 Units for equivalence) was administered: 50 Units per masseter muscle and 33.3 Units per anterior temporal muscle, injected bilaterally in a single session.
PROCEDUREDry Needling (DN)
Deep dry needling application to the masseter and anterior temporal muscles. The procedure was performed in 3 sessions with one-week intervals.
Injection of PrabotulinumtoxinA. A total of 50 Units was administered: 15 Units per masseter muscle and 10 Units per anterior temporal muscle, injected bilaterally in a single session.
Sponsors
Recep Tayyip Erdogan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
Patients aged 18-65 years diagnosed with "Probable Bruxism". ASA I or ASA II physical status. Patients with severe pain, defined as a score of 8 or higher on a 0-10 Visual Analogue Scale (VAS) (where 0 = no pain and 10 = worst possible pain).
Exclusion criteria
Allergy to botulinum toxin, silver, or gold. Pregnancy, neuromuscular diseases, or bleeding disorders. Previous TMJ surgery or current use of other treatments.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Intensity Measured by Visual Analog Scale (VAS) | Baseline, 1 month, and 3 months. | Self-reported pain intensity on a scale from 0 (no pain) to 10 (worst imaginable pain). Measurements were taken at baseline, 1 month, and 3 months post-treatment. |
| Masseter and Anterior Temporal Muscle Thickness Via Ultrasonography (USG) | 3rd month post-treatment. | Measurement of the thickness of the masseter and anterior temporal muscles in millimeters (cm) using a high-frequency linear probe. Measurements are taken bilaterally both at rest and during maximum voluntary contraction (clenching). |
Countries
Turkey (Türkiye)
Contacts
PRINCIPAL_INVESTIGATOREmre BALABAN
Assoc. Prof.
Participant flow
Recruitment details
The study was conducted on patients who applied to the Department of Oral and Maxillofacial Surgery at Recep Tayyip Erdogan University Faculty of Dentistry in 2026. Participants were diagnosed with bruxism based on clinical examinations and medical history. A total of 72 patients who met the inclusion criteria were initially enrolled.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 23 Participants |
| Baseline Muscle Thickness Left masseter contracted | 1.195 cm STANDARD_DEVIATION 0.19 |
| Baseline Muscle Thickness Left masseter relaxed | 0.852 cm STANDARD_DEVIATION 0.182 |
| Baseline Muscle Thickness Left temporalis contracted | 0.481 cm STANDARD_DEVIATION 0.146 |
| Baseline Muscle Thickness Left temporalis relaxed | 0.343 cm STANDARD_DEVIATION 0.101 |
| Baseline Muscle Thickness Right masseter contracted | 1.369 cm STANDARD_DEVIATION 0.219 |
| Baseline Muscle Thickness Right masseter relaxed | 0.742 cm STANDARD_DEVIATION 0.134 |
| Baseline Muscle Thickness Right temporalis contracted | 0.550 cm STANDARD_DEVIATION 0.103 |
| Baseline Muscle Thickness Right temporalis relaxed | 0.433 cm STANDARD_DEVIATION 0.107 |
| Race and Ethnicity Not Collected | 0 Participants |
| Region of Enrollment Turkey | 23 Participants |
| Sex: Female, Male Female | 20 Participants |
| Sex: Female, Male Male | 8 Participants |
| VAS score at baseline | 8.909 scores on a scale STANDARD_DEVIATION 0.426 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 22 | 0 / 23 | 0 / 24 |
| other Total, other adverse events | 0 / 22 | 0 / 23 | 0 / 24 |
| serious Total, serious adverse events | 0 / 22 | 0 / 23 | 0 / 24 |
Outcome results
None listed