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Completed

NCT Number: NCT06583551

Effectiveness of Botox, Dry Needling, Pharmacological Treatment, and Manual Therapy for Bruxism-Induced Myalgia

Eighty individuals (44 female, 36 male), which were randomly divided into 4 groups of 20 patients each, due to the treatment type: Botulinum toxin (BTX); Dry needling (DN); Pharmacological therapy (PT) and Manual therapy (MT). All treatments were carried out by the same maxillofacial surgeon. An informed consent form was obtained from all participants.

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Key information

Conditions

Myalgia Behavior Bruxism Habits Muscular Diseases Musculoskeletal Diseases Musculoskeletal Pain Nervous System Diseases Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Quality of Life Signs and Symptoms Stomatognathic Diseases Tooth Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Health Sciences

Istanbul, Turkey (Türkiye)

About this study

The study aimed to assess and compare the effectiveness of 4 different methods in the management bruxism: Botulinum toxin (BTX-A), dry needling (DN), pharmacological therapy (PT), and manual therapy (MT). 80 bruxist patients (44 female, 36 male) were randomly divided into 4 groups of 20 patients each. Botulinum toxin, dry needling, pharmacological therapy and manual therapy were carried out by the same maxillofacial surgeon in all patients. The following measurements were recorded by another investigator in each group, at baseline (before treatment) and at post-treatment intervals of 2nd, 4th, and 12th weeks; Visual Analogue Scale (VAS) for pain, maximum painless mouth opening (mm), Oral Health Impact Profile14 (OHIP-14).

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Adult patients aged 18 to 65 years with complete dentition,
  • Patients classified as American Society of Anesthesiologists (ASA) physical status ASA I or ASA II
  • Patients experiencing moderate to severe pain in the masticatory muscles related to bruxism,
  • Patients who had not previously been treated for bruxism
  • Patients who were diagnosed with bruxism were excluded from the study.

Exclusion criteria

  • Presence of temporomandibular joint disorder
  • Known allergy to botulinum toxin
  • Pregnancy
  • Presence of neuromuscular disease
  • Chronic use of muscle relaxant medication within the last 3 months.

Treatment and study plan

Botulinum toxin

Drug

Botulinum toxin, produced by Clostridium botulinum, is a neurotoxin. Presently, there are 7 serotypes (A, B, C1, D, E, F, G). Botulinum neurotoxin A (BoNT-A) is the most frequently used variant in clinical applications.

Other names: Intramuscular injection of Botulinum toxin A. (BoNT-A)

dry needling

Procedure

Dry needling (DN) is a type of acupuncture therapy, that uses a thin filiform needle to penetrate the skin and stimulate underlying myofascial trigger points (MTrPs) and muscular, and connective tissues.

Myorel

Drug

Metacarbamol (380mg), paracetamol (300mg)

Manual Therapy

Procedure

Manual therapy (MT) entails the use of the hands to apply a force with a therapeutic intent, including techniques such as massage, joint mobilization/manipulation, myofascial release, nerve manipulation, strain/counterstrain, and acupressure.

Primary outcomes

  1. Pain in at rest and at chewing

    Time frame: 12 weeks

    Average pain was measured by a scale, named Visual analogue scale.

  2. MMO

    Time frame: 12 weeks

    Maximum painless mouth opening (in millimeters) was measured by a special ruler.

  3. OHRQoL questionnaire

    Time frame: 12 weeks

    Oral-health-related quality of life

Sponsors and collaborators

Lead sponsor

Saglik Bilimleri Universitesi

Other

Registry information

Official study title

Comparison of the Effectiveness of Botox, Dry Needling, Pharmacological Treatment, and Manual Therapy for Bruxism-Induced Myalgia: a Prospective Randomized Study

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Sep 4, 2024
Registry last updated
Sep 4, 2024

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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