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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07511335
Enrollment
40
Registered
2026-04-06
Start date
2019-02-26
Completion date
2022-01-31
Last updated
2026-04-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bruxism, Dry Needling, Stabilization Splint

Keywords

bruxism, dry needling, stabilization splint, Temporomandibular disorders

Brief summary

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.

Interventions

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.

PROCEDUREDry Needling

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.

Sponsors

Kocaeli University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Pain intensity (VAS)Baseline, 1 month, 3 months, and 6 monthsPain 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.
Maximum mouth opening (MMO)Baseline, 1 month, 3 months, and 6 monthsMaximum 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

MeasureTime frameDescription
Oral Health-Related Quality of Life (OHIP-TMD)Baseline, 3 months, and 6 monthsOral 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.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 14, 2026