Comparison of Dry Needling and Two Botulinum Toxins for Bruxism

Sponsored by Recep Tayyip Erdogan University

About this trial

Last updated 2 months ago

Study ID

2026/19

Status

Active not recruiting

Type

Interventional

Phase

N/A

Placebo

Accepting

18 to 65 Years

All Sexes

Trial Timing

Ended a month ago

What is this trial about?

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

What are the participation requirements?

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.