NCT07452510

Comparison of Dry Needling and Two Botulinum Toxins for Bruxism

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 69 (actual)
• Sponsor: Recep Tayyip Erdogan University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

Conditions

• Bruxism
• Sleep Bruxism, Adult
• Awake Bruxism
• Masseter Muscle Hypertrophy
• Temporomandibular Disorders

Interventions

Type	Name	Description
PROCEDURE	Dry Needling (DN)	Deep dry needling application to the masseter and anterior temporal muscles. The procedure was performed in 3 sessions with one-week intervals.
DRUG	PrabotulinumtoxinA	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.
DRUG	Abobotulinumtoxina	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.

Timeline

• Start date: 2026-01-09
• Primary completion: 2026-04-15
• Completion: 2026-04-16
• First posted: 2026-03-05
• Last updated: 2026-03-05

Locations

1 site across 1 country: Turkey (Türkiye)