Comparison of Dry Needling and Two Botulinum Toxins for Bruxism

N/AActive Not RecruitingNCT07452510

Recep Tayyip Erdogan University69 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Bruxism Sleep Bruxism, Adult Awake Bruxism

Interventions

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.

PrabotulinumtoxinADRUG

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.

AbobotulinumtoxinaDRUG

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Visual Analog Scale (VAS) Score for Pain Intensity

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.

Time frame: Baseline (Day 0), 1st month, and 3rd month post-treatment.

Masseter and Anterior Temporal Muscle Thickness via Ultrasonography (USG)

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).

Time frame: Baseline (Day 0) and 3rd month post-treatment.