Clinical Trial

Comparison of Dry Needling and Two Botulinum Toxins for Bruxism

Completed
View on ClinicalTrials.gov →
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
Protocol Amendment History 2 changes
critical Trial completed 2026-05-21
critical Primary endpoint(s) modified 2026-05-21
Trial Details
NCT Number NCT07452510
Lead Sponsor Recep Tayyip Erdogan University
Conditions Bruxism, Sleep Bruxism, Adult, Awake Bruxism, Masseter Muscle Hypertrophy, Temporomandibular Disorders
Enrollment 72 participants
Start Date 2026-01-09
Primary Completion 2026-04-08 (estimated)
Study Completion 2026-04-08 (estimated)
Updated on ClinicalTrials.gov 2026-05-20