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Completed

NCT Number: NCT07452510

Comparison of Dry Needling and Two Botulinum Toxins for Bruxism

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

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Key information

Conditions

Bruxism Awake Bruxism Behavior Craniomandibular Disorders Habits Jaw Diseases Joint Diseases Mandibular Diseases Masseter Muscle Hypertrophy Masticatory Muscles, Hypertrophy of Mental Disorders Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Parasomnias Sleep Bruxism Sleep Bruxism, Adult Sleep Wake Disorders Stomatognathic Diseases Temporomandibular Disorders Temporomandibular Joint Disorders Tooth Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Recep Tayyip Erdogan university

Rize, Center, 53100, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

prabotulinumtoxinA

Drug

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.

AbobotulinumtoxinA

Drug

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.

Primary outcomes

  1. Pain Intensity Measured by Visual Analog Scale (VAS)

    Time frame: Baseline, 1 month, and 3 months.

    Self-reported pain intensity on a scale from 0 (no pain) to 10 (worst imaginable pain). Measurements were taken at baseline, 1 month, and 3 months post-treatment.

  2. Masseter and Anterior Temporal Muscle Thickness Via Ultrasonography (USG)

    Time frame: 3rd month post-treatment.

    Measurement of the thickness of the masseter and anterior temporal muscles in millimeters (cm) using a high-frequency linear probe. Measurements are taken bilaterally both at rest and during maximum voluntary contraction (clenching).

Sponsors and collaborators

Lead sponsor

Recep Tayyip Erdogan University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 5, 2026
Registry last updated
May 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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