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| ID | Type | Description | Link |
|---|---|---|---|
| 2026/19 | Other Identifier | Ethics Committee Approval from RTEU Non-Interventional Clinical Research Ethics Committee |
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dry Needling Group | Experimental | Patients in this group received deep dry needling treatment. The procedure was performed once a week for a total of three sessions. Sterile needles (0.25x25 mm) were applied to myofascial trigger points in the masseter and anterior temporal muscles. |
|
| PraBotulinumtoxinA | Experimental | Patients received a single-session injection of 50 Units (U) of PrabotulinumtoxinA. The total dose was distributed bilaterally as 15U for each masseter muscle (at 3 points) and 10U for each anterior temporal muscle (at 2 points). |
|
| AbobotulinumtoxinA | Experimental | Patients received a single-session injection of approximately 167 Units (U) of AbobotulinumtoxinA. The total dose was distributed bilaterally as 50U for each masseter muscle (at 3 points) and approximately 33U for each anterior temporal muscle (at 2 points). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dry Needling (DN) | Procedure | Deep dry needling application to the masseter and anterior temporal muscles. The procedure was performed in 3 sessions with one-week intervals. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain Intensity Measured by Visual Analog Scale (VAS) | 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. | Baseline, 1 month, and 3 months. |
| Masseter and Anterior Temporal Muscle Thickness Via Ultrasonography (USG) | 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). | 3rd month post-treatment. |
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Emre BALABAN | Assoc. Prof. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Recep Tayyip Erdogan university | Rize | Center | 53100 | Turkey (Türkiye) |
The individual participant data will not be shared to protect participant privacy, in accordance with the ethical approval obtained for this study.
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Dry Needling Group | Patients in this group received deep dry needling treatment. The procedure was performed once a week for a total of three sessions. Sterile needles (0.25x25 mm) were applied to myofascial trigger points in the masseter and anterior temporal muscles. |
| FG001 | PraBotulinumtoxinA | Patients received a single-session injection of 50 Units (U) of PrabotulinumtoxinA. The total dose was distributed bilaterally as 15U for each masseter muscle (at 3 points) and 10U for each anterior temporal muscle (at 2 points). |
| FG002 | AbobotulinumtoxinA | Patients received a single-session injection of approximately 167 Units (U) of AbobotulinumtoxinA. The total dose was distributed bilaterally as 50U for each masseter muscle (at 3 points) and approximately 33U for each anterior temporal muscle (at 2 points). |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Dry Needling Group | Patients in this group received deep dry needling treatment. The procedure was performed once a week for a total of three sessions. Sterile needles (0.25x25 mm) were applied to myofascial trigger points in the masseter and anterior temporal muscles. |
| BG001 | PraBotulinumtoxinA |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Age of participants at baseline |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Pain Intensity Measured by Visual Analog Scale (VAS) | 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. | Posted | Mean | Standard Deviation | VAS score (0-10) | Baseline, 1 month, and 3 months. |
|
From treatment administration to the end of the 3-month follow-up period.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Dry Needling Group | Patients in this group received deep dry needling treatment. The procedure was performed once a week for a total of three sessions. Sterile needles (0.25x25 mm) were applied to myofascial trigger points in the masseter and anterior temporal muscles. |
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This study has several limitations. First, it was conducted in a single center with a relatively small sample size, which may limit the generalizability of the results. Second, the follow-up period was limited to 3 months, preventing evaluation of long-term effects. Third, the study was single-blinded, which may introduce measurement bias. Additionally, pain assessment using VAS is subjective, and ultrasonographic measurements may be operator-dependent.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Assoc. Prof. Emre Balaban | Recep Tayyip Erdogan University | +905053930478 | samilesad.guven@erdogan.edu.tr |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 8, 2026 | Apr 8, 2026 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D002012 | Bruxism |
| D020186 | Sleep Bruxism |
| C563600 | Masticatory Muscles, Hypertrophy of |
| D013705 | Temporomandibular Joint Disorders |
| ID | Term |
|---|---|
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
| D006184 | Habits |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D000079245 | Dry Needling |
| C000630868 | prabotulinumtoxin A |
| C542869 | abobotulinumtoxinA |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
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| PrabotulinumtoxinA | Drug | 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. |
|
| Abobotulinumtoxina | Drug | 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. |
|
Patients received a single-session injection of 50 Units (U) of PrabotulinumtoxinA. The total dose was distributed bilaterally as 15U for each masseter muscle (at 3 points) and 10U for each anterior temporal muscle (at 2 points). |
| BG002 | AbobotulinumtoxinA | Patients received a single-session injection of approximately 167 Units (U) of AbobotulinumtoxinA. The total dose was distributed bilaterally as 50U for each masseter muscle (at 3 points) and approximately 33U for each anterior temporal muscle (at 2 points). |
| BG003 | Total | Total of all reporting groups |
Three participants were excluded from the final analysis to maintain data homogeneity and strictly adhere to the study protocol. One participant in the Prabotulinumtoxina group was excluded due to a post-injection complication (paradoxical masseteric bulging), and two participants in the AbobotulinumtoxinA group were excluded because they failed to attend the 1st and 3rd-month follow-up appointments.
| Count of Participants |
| Participants |
|
| Sex: Female, Male | Sex distribution of participants | Three participants were excluded from the final analysis to maintain data homogeneity and strictly adhere to the study protocol. One participant in the Prabotulinumtoxina group was excluded due to a post-injection complication (paradoxical masseteric bulging), and two participants in the AbobotulinumtoxinA group were excluded because they failed to attend the 1st and 3rd-month follow-up appointments. | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Three participants were excluded from the final analysis to maintain data homogeneity and strictly adhere to the study protocol. One participant in the Prabotulinumtoxina group was excluded due to a post-injection complication (paradoxical masseteric bulging), and two participants in the AbobotulinumtoxinA group were excluded because they failed to attend the 1st and 3rd-month follow-up appointments. | Number | Participants |
|
| VAS score at baseline | Pain intensity was assessed using the Visual Analogue Scale (VAS) on a scale of 0 to 10, where 0 represents 'no pain' and 10 represents 'the worst possible pain.' Higher values represent a worse outcome (more severe pain). | Mean | Standard Deviation | scores on a scale |
|
| Baseline Muscle Thickness | Mean | Standard Deviation | cm |
|
| OG002 | AbobotulinumtoxinA | Patients received a single-session injection of approximately 167 Units (U) of AbobotulinumtoxinA. The total dose was distributed bilaterally as 75U for each masseter muscle (at 3 points) and approximately 33U for each anterior temporal muscle (at 2 points). |
|
|
| Primary | Masseter and Anterior Temporal Muscle Thickness Via Ultrasonography (USG) | 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). | Posted | Mean | Standard Deviation | cm | 3rd month post-treatment. |
|
|
|
| 0 |
| 22 |
| 0 |
| 22 |
| 0 |
| 22 |
| EG001 | PraBotulinumtoxinA | Patients received a single-session injection of 50 Units (U) of PrabotulinumtoxinA. The total dose was distributed bilaterally as 15U for each masseter muscle (at 3 points) and 10U for each anterior temporal muscle (at 2 points). | 0 | 23 | 0 | 23 | 0 | 23 |
| EG002 | AbobotulinumtoxinA | Patients received a single-session injection of approximately 167 Units (U) of AbobotulinumtoxinA. The total dose was distributed bilaterally as 50U for each masseter muscle (at 3 points) and approximately 33U for each anterior temporal muscle (at 2 points). | 0 | 24 | 0 | 24 | 0 | 24 |
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| D020447 |
| Parasomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |
| D017271 | Craniomandibular Disorders |
| D008336 | Mandibular Diseases |
| D007571 | Jaw Diseases |
| D009140 | Musculoskeletal Diseases |
| D007592 | Joint Diseases |
| D009135 | Muscular Diseases |
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
|
| Left temporalis relaxed |
|
| Left temporalis contracted |
|
| Right masseter relaxed |
|
| Right masseter contracted |
|
| Right temporalis relaxed |
|
| Right temporalis contracted |
|