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NCT Number: NCT07511335

Dry Needling Versus Stabilization Splint Therapy in Bruxism Associated Myofascial Temporomandibular Disorders

This prospective comparative clinical study included 40 patients diagnosed with myofascial TMD who met the diagnostic criteria for bruxism established by the American Academy of Sleep Medicine. Participants were allocated into two groups according to treatment preference: stabilization splint therapy or dry needling. Maximum mouth opening (MMO), pain intensity assessed using the Visual Analog Scale (VAS), and Oral Health Impact Profile for TMD (OHIP-TMD) scores were recorded at baseline and at 1, 3, and 6 months post-treatment.

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Key information

Conditions

Bruxism Behavior Craniomandibular Disorders Dry Needling Habits Jaw Diseases Joint Diseases Mandibular Diseases Muscular Diseases Musculoskeletal Diseases Stabilization Splint Stomatognathic Diseases Temporomandibular Joint Disorders Tooth Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kocaeli University

Kocaeli, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adults aged ≥18 years
  • Clinical presence of temporomandibular disorder (TMD) symptoms (e.g., joint sounds such as clicking, and/or limited mouth opening)
  • Diagnosis of bruxism according to the American Academy of Sleep Medicine (AASM) criteria
  • Moderate to severe pain in the masseter and/or temporalis muscles, defined as a Visual Analog Scale (VAS) score ≥3.5

Exclusion criteria

  • Presence of connective tissue disorders or autoimmune diseases
  • Current use of systemic steroids, muscle relaxants, or narcotic (opioid) medications
  • History of neuromuscular disorders
  • Previous temporomandibular joint (TMJ) surgery
  • History of significant TMJ trauma
  • Presence of dentofacial deformities
  • Any condition that, in the opinion of the investigator, may interfere with study participation or outcome assessment

Treatment and study plan

stabilization splint

Device

A maxillary hard acrylic stabilization splint was fabricated to provide uniform occlusal contacts in centric occlusion. Patients were instructed to use the splint for at least two-thirds of the day over a period of 6 months, except during eating and oral hygiene procedures. Monthly follow-up visits were conducted for occlusal adjustments.

dry needling

Procedure

Dry needling was applied to the masseter and temporalis muscles using sterile acupuncture needles. The procedure targeted myofascial trigger points and was performed in three sessions at 1-week intervals. Needles were inserted into the identified نقاط and manually stimulated during each session.

Primary outcomes

  1. Pain intensity (VAS)

    Time frame: Baseline, 1 month, 3 months, and 6 months

    Pain intensity was assessed using a 10-cm Visual Analog Scale (VAS), where 0 indicates no pain and 10 indicates the worst imaginable pain. Measurements were recorded at baseline and during follow-up visits to evaluate changes in pain levels over time.

  2. Maximum mouth opening (MMO)

    Time frame: Baseline, 1 month, 3 months, and 6 months

    Maximum mouth opening (MMO) was measured in millimeters as the distance between the incisal edges of the maxillary and mandibular central incisors at maximum painless mouth opening. This parameter was used to assess functional improvement in mandibular mobility.

Secondary outcomes

  1. Oral Health-Related Quality of Life (OHIP-TMD)

    Time frame: Baseline, 3 months, and 6 months

    Oral health-related quality of life was evaluated using the Oral Health Impact Profile for Temporomandibular Disorders (OHIP-TMD), a validated patient-reported outcome measure assessing the impact of TMD on daily life and well-being.

Sponsors and collaborators

Lead sponsor

Kocaeli University

Other

Registry information

Official study title

Dry Needling Versus Stabilization Splint Therapy in Bruxism Associated Myofascial Temporomandibular Disorders: A Prospective Comparative Study

Important dates

Study start
2019
Primary completion
2021
Study completion
2022
First posted
Apr 6, 2026
Registry last updated
Apr 13, 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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