Evaluation of the Effects of Dry Needling and Botulinum Toxin Applications on VAS Scores and Muscle Thickness in the Masseter and Temporalis Muscles of Patients Diagnosed With Bruxism
Overview
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Recep Tayyip Erdogan University
- Enrollment
- 69
- Locations
- 1
- Primary Endpoint
- Visual Analog Scale (VAS) Score for Pain Intensity
Overview
Brief Summary
- 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.
- 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.
- Results:The results will be analyzed following the completion of the 3-month follow-up period
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients aged 18-65 years diagnosed with chronic bruxism.
- •Presence of myofascial pain in masseter and temporal muscles for at least 3 months.
- •Patients who have not received Botulinum Toxin or dry needling treatment in the last 6 months.
- •Patients who voluntarily agreed to participate and signed the informed consent form.
Exclusion Criteria
- •Pregnancy or breastfeeding.
- •Known allergy to Botulinum Toxin or any of its ingredients.
- •Presence of neuromuscular diseases (e.g., Myasthenia Gravis, Lambert-Eaton Syndrome).
- •Active infection or skin disease at the injection sites.
- •Systemic diseases that may affect muscle or bone metabolism.
- •Psychiatric disorders or use of medications that might interfere with pain perception.
Arms & Interventions
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.
Intervention: Dry Needling (DN) (Procedure)
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).
Intervention: PrabotulinumtoxinA (Drug)
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).
Intervention: Abobotulinumtoxina (Drug)
Outcomes
Primary Outcomes
Visual Analog Scale (VAS) Score for Pain Intensity
Time Frame: Baseline (Day 0), 1st month, and 3rd month post-treatment.
Patients are asked to rate their current pain level on a 100 mm (or 10 cm) horizontal line, where 0 represents "no pain" and 10 represents "the worst possible pain." Higher scores indicate greater pain intensity.
Masseter and Anterior Temporal Muscle Thickness via Ultrasonography (USG)
Time Frame: Baseline (Day 0) and 3rd month post-treatment.
Measurement of the thickness of the masseter and anterior temporal muscles in millimeters (mm) using a high-frequency linear probe. Measurements are taken bilaterally both at rest and during maximum voluntary contraction (clenching).
Secondary Outcomes
No secondary outcomes reported
Investigators
Şamil Güven
DDS, Resident in Oral and Maxillofacial Surgery
Recep Tayyip Erdogan University