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

April 7, 2026 updated by: Hatice Duran, Kocaeli University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Stabilization Splint Therapy
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
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.
Experimental: Dry Needling
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, 1 month, 3 months, and 6 months
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.
Baseline, 1 month, 3 months, and 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, 3 months, and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kocaeli University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 26, 2019

Primary Completion (Actual)

June 21, 2021

Study Completion (Actual)

January 31, 2022

Study Registration Dates

First Submitted

March 30, 2026

First Submitted That Met QC Criteria

March 30, 2026

First Posted (Actual)

April 6, 2026

Study Record Updates

Last Update Posted (Actual)

April 13, 2026

Last Update Submitted That Met QC Criteria

April 7, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Kocaeli University (2019/6)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The datasets generated and/or analyzed during the current study are not publicly available due to patient privacy and ethical restrictions but are available from the corresponding author on reasonable request.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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