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

NCT07511335 | Completed DMC

• 1 other identifier: Kocaeli University (2019/6)
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Bruxism; Dry Needling; Stabilization Splint

Keywords

bruxism; dry needling; stabilization splint; Temporomandibular disorders

Outcome Measures

Primary Outcomes (2)

• Pain intensity (VAS)

  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.

  Baseline, 1 month, 3 months, and 6 months

• Maximum mouth opening (MMO)

  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.

  Baseline, 1 month, 3 months, and 6 months

Secondary Outcomes (1)

• Oral Health-Related Quality of Life (OHIP-TMD)

  Baseline, 3 months, and 6 months

Study Arms (2)

Stabilization Splint Therapy

ACTIVE COMPARATOR

Patients received a maxillary hard acrylic stabilization splint designed to provide uniform occlusal contacts. Participants were instructed to use the splint for at least two-thirds of the day over a 6-month period, except during eating and oral hygiene procedures. Monthly follow-up visits were conducted for necessary adjustments.

Device: Stabilization Splint

Dry Needling

EXPERIMENTAL

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

Procedure: Dry Needling

Interventions

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.

Stabilization Splint Therapy

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.

Dry Needling

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kocaeli University: lead

Study Sites (1)

Kocaeli University

Kocaeli, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Bruxism; Temporomandibular Joint Disorders

Interventions

Dry Needling

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases; Habits; Behavior; Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assos. Prof.

Study Record Dates

• First Submitted: March 30, 2026
• First Posted: April 6, 2026
• Study Start: February 26, 2019
• Primary Completion: June 21, 2021
• Study Completion: January 31, 2022
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP

Locations

TU (1)