BruxismNCT07511335
Dry Needling Versus Stabilization Splint Therapy in Bruxism Associated Myofascial Temporomandibular Disorders
A study testing Stabilization Splint and Dry Needling in people with Bruxism and Dry Needling, run by Kocaeli University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bruxism, Dry Needling, Stabilization Splint
- What is being tested?
- Stabilization Splint and Dry Needling
- Type of treatment
- Pill or oral medicine, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 26 Feb 2019to 31 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Bruxism, Dry Needling, Stabilization Splint
- Being tested
- Stabilization Splint, Dry Needling
- Keywords
- bruxism, dry needling, stabilization splint, Temporomandibular disorders
- Medical subject headings
- Bruxism, Temporomandibular Joint Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stabilization SplintDevice
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 NeedlingProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Dry Needling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline, 1 month, 3 months, and 6 months
Secondary outcomes (1)
Oral Health-Related Quality of Life (OHIP-TMD)
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.
Measured: Baseline, 3 months, and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2026
- Study start26 Feb 2019
- Primary completion21 Jun 2021
- Study completion31 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BruxismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kocaeli University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hatice Duran, Kocaeli University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07511335
- Sponsor's protocol ID
- Kocaeli University (2019/6)
- Status last verified
- Apr 2026
- First submitted
- 30 Mar 2026
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dry Needling Versus Stabilization Splint Therapy in Bruxism Associated Myofascial Temporomandibular Disorders: A Prospective Comparative Study
- ClinicalTrials.gov ID
- NCT07511335
- Acronym / sponsor ID
- Kocaeli University (2019/6)
- Conditions
- Bruxism, Dry Needling, Stabilization Splint
- Keywords
- bruxism, dry needling, stabilization splint, Temporomandibular disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Kocaeli UniversityUniversity, hospital or other
- Study start
- 26 Feb 2019 (actual)
- Primary completion
- 21 Jun 2021 (actual)
- Study completion
- 31 Jan 2022 (actual)
- First posted
- 6 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stabilization Splint Therapy | Active comparator | Device: Stabilization SplintPatients 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. |
| Dry Needling | Experimental | Procedure: Dry NeedlingPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stabilization SplintA 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. | Device | Stabilization Splint Therapy |
| Dry NeedlingDry 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. | Procedure or surgery | Dry Needling |
Primary outcome
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.
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.
1 secondary outcome
Oral Health-Related Quality of Life (OHIP-TMD)
Time frame: Baseline, 3 months, and 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Individual participant dataSharing planned: Yes. 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.
Related trials for Bruxism
RecruitingObservational study
Bruxism, Anxiety, and Periodontal Status Among Dental Students
Bruxism, Anxiety
RecruitingObservational study
Movement of Dental Implants During Osseointegration
Dental Implants, Osseointegration
Enrolling by invitationObservational study
The General Aim is to Implement Clinical Assessment of Overload by Voluntary Bite Force Registration to Enable Future Simple But Precise Risk Assessment to Provide Individualized Treatment Plans.
Dental Implant, Bruxism
RecruitingObservational study
Effect Of Orofacial Pain Therapy On Bruxism
Masticatory Myofascial Pain
Not yet recruiting
Influence Of Different Relaxation Techniques On Stress Level For Patients With Bruxism Using Salivary Biomarkers.
Bruxism, Stress (Psychology)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stabilization Splint and Dry Needling in people with Bruxism and Dry Needling, run by Kocaeli University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity (VAS) (time frame: Baseline, 1 month, 3 months, and 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.