N/A N=72 Randomized Single-blind Treatment

Comparison of Dry Needling and Two Botulinum Toxins for Bruxism

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

Bottom Line

View on ClinicalTrials.gov: NCT07452510 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

May 2026

Primary outcome: Primary: Pain Intensity Measured by Visual Analog Scale (VAS) — 8.909; 8.957; 9.167; 1.591 VAS score (0-10)

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Dry Needling (DN) (Procedure); PrabotulinumtoxinA (Drug); Abobotulinumtoxina (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Recep Tayyip Erdogan University
Primary completion: Apr 2026

Outcome Measures

Outcome	Result	p-value
PRIMARY Pain Intensity Measured by Visual Analog Scale (VAS)	8.909; 8.957; 9.167; 1.591; 0.957; 0.417	—
PRIMARY Masseter and Anterior Temporal Muscle Thickness Via Ultrasonography (USG)	0,770; 0,732; 0,702; 1,192; 1,101; 0,996	—

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

Eligibility Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT07452510). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.