BruxismNCT07452510

Comparison of Dry Needling and Two Botulinum Toxins for Bruxism

A study testing Dry Needling (DN), PrabotulinumtoxinA and Abobotulinumtoxina in people with Bruxism and Sleep Bruxism, Adult, run by Recep Tayyip Erdogan University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

1. Aim: The aim of this study is to prospectively compare the clinical efficacy of Dry Needling (DN), Nabota (PrabotulinumtoxinA), and Dysport (AbobotulinumtoxinA) treatments on the thickness of masseter and anterior temporal muscles and pain intensity (VAS) in patients diagnosed with chronic bruxism. 2. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Bruxism, Sleep Bruxism, Adult, Awake Bruxism
What is being tested?: Dry Needling (DN), PrabotulinumtoxinA and Abobotulinumtoxina
Type of treatment: Injection or infusion, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 72 participants
Where: 1 siteTurkey (Türkiye)
Study dates: 9 Jan 2026to 8 Apr 2026
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients aged 18-65 years diagnosed with "Probable Bruxism". ASA I or ASA II physical status. Patients with severe pain, defined as a score of 8 or higher on a 0-10 Visual Analogue Scale (VAS) (where 0 = no pain and 10 = worst possible pain).

Who cannot join

Allergy to botulinum toxin, silver, or gold. Pregnancy, neuromuscular diseases, or bleeding disorders. Previous TMJ surgery or current use of other treatments.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

Recep Tayyip Erdogan university
Rize, Center, 53100

Other trials in Turkey (Türkiye)

About this study

Official title: Evaluation of the Effects of Dry Needling and Botulinum Toxin Applications on VAS Scores and Muscle Thickness in the Masseter and Temporalis Muscles of Patients Diagnosed With Bruxism

Aim: The aim of this study is to prospectively compare the clinical efficacy of Dry Needling (DN), Nabota (PrabotulinumtoxinA), and Dysport (AbobotulinumtoxinA) treatments on the thickness of masseter and anterior temporal muscles and pain intensity (VAS) in patients diagnosed with chronic bruxism.
Material and Method: This randomized, prospective, and single-blind clinical study will be conducted on 60 patients diagnosed with bruxism. Patients will be divided into three groups: Dry Needling (n=20), Nabota (n=20), and Dysport (n=20). Pain levels will be assessed using the Visual Analog Scale (VAS) at baseline, 1st month, and 3rd month. Muscle thicknesses will be measured using ultrasonography (USG) at baseline and 3rd month. Data distribution will be analyzed using the Kolmogorov-Smirnov test; intergroup comparisons will be performed using ANOVA and Post-hoc Duncan tests.
Results:The results will be analyzed following the completion of the 3-month follow-up period

Conditions: Bruxism, Sleep Bruxism, Adult, Awake Bruxism, Masseter Muscle Hypertrophy, Temporomandibular Disorders
Being tested: Dry Needling (DN), PrabotulinumtoxinA, Abobotulinumtoxina
Keywords: Bruxism, Botulinum Toxins, Type A, Dry Needling, Masseter Muscle, Temporal Muscle, Ultrasonography
Medical subject headings: Bruxism, Sleep Bruxism, Masticatory Muscles, Hypertrophy of, Temporomandibular Joint Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Dry Needling (DN)Procedure or surgery
Deep dry needling application to the masseter and anterior temporal muscles. The procedure was performed in 3 sessions with one-week intervals.
PrabotulinumtoxinADrug
Injection of PrabotulinumtoxinA. A total of 50 Units was administered: 15 Units per masseter muscle and 10 Units per anterior temporal muscle, injected bilaterally in a single session.
AbobotulinumtoxinaDrug
Injection of AbobotulinumtoxinA. A total of 500 Units (reconstituted to approximately 167 Units for equivalence) was administered: 50 Units per masseter muscle and 33.3 Units per anterior temporal muscle, injected bilaterally in a single session.

Study groups in NCT07452510
Study group	Role	What they receive
Dry Needling Group	Experimental	Patients in this group received deep dry needling treatment. The procedure was performed once a week for a total of three sessions. Sterile needles (0.25x25 mm) were applied to myofascial trigger points in the masseter and anterior temporal muscles. Receives: Procedure: Dry Needling (DN)
PraBotulinumtoxinA	Experimental	Patients received a single-session injection of 50 Units (U) of PrabotulinumtoxinA. The total dose was distributed bilaterally as 15U for each masseter muscle (at 3 points) and 10U for each anterior temporal muscle (at 2 points). Receives: Drug: PrabotulinumtoxinA
AbobotulinumtoxinA	Experimental	Patients received a single-session injection of approximately 167 Units (U) of AbobotulinumtoxinA. The total dose was distributed bilaterally as 50U for each masseter muscle (at 3 points) and approximately 33U for each anterior temporal muscle (at 2 points). Receives: Drug: Abobotulinumtoxina

What is being measured

The primary outcome is the main question the study is designed to answer.

Pain Intensity Measured by Visual Analog Scale (VAS)
Self-reported pain intensity on a scale from 0 (no pain) to 10 (worst imaginable pain). Measurements were taken at baseline, 1 month, and 3 months post-treatment.
Measured: Baseline, 1 month, and 3 months.
Masseter and Anterior Temporal Muscle Thickness Via Ultrasonography (USG)
Measurement of the thickness of the masseter and anterior temporal muscles in millimeters (cm) using a high-frequency linear probe. Measurements are taken bilaterally both at rest and during maximum voluntary contraction (clenching).
Measured: 3rd month post-treatment.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

9 Jan 20268 Apr 2026

First posted5 Mar 2026
Study start9 Jan 2026
Primary completion8 Apr 2026
Study completion8 Apr 2026

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
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: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 72 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07452510
Sponsor's protocol ID: 2026/19
Other IDs: 2026/19
Status last verified: Apr 2026
First submitted: 17 Feb 2026
Last updated: 20 May 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: The individual participant data will not be shared to protect participant privacy, in accordance with the ethical approval obtained for this study.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Bruxism trials

Study at a glance

From the registry record, last updated by the sponsor on 20 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of the Effects of Dry Needling and Botulinum Toxin Applications on VAS Scores and Muscle Thickness in the Masseter and Temporalis Muscles of Patients Diagnosed With Bruxism
ClinicalTrials.gov ID: NCT07452510
Acronym / sponsor ID: 2026/19
Conditions: Bruxism, Sleep Bruxism, Adult, Awake Bruxism, Masseter Muscle Hypertrophy, Temporomandibular Disorders
Keywords: Bruxism, Botulinum Toxins, Type A, Dry Needling, Masseter Muscle, Temporal Muscle, Ultrasonography
Study type: Interventional
Recruitment status: Completed
Enrolment: 72 participants (actual)
Lead sponsor: Recep Tayyip Erdogan UniversityUniversity, hospital or other
Study start: 9 Jan 2026 (actual)
Primary completion: 8 Apr 2026 (actual)
Study completion: 8 Apr 2026 (actual)
First posted: 5 Mar 2026 (actual)
Results: Posted 20 May 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Aim: The aim of this study is to prospectively compare the clinical efficacy of Dry Needling (DN), Nabota (PrabotulinumtoxinA), and Dysport (AbobotulinumtoxinA) treatments on the thickness of masseter and anterior temporal muscles and pain intensity (VAS) in patients diagnosed with chronic bruxism.
Material and Method: This randomized, prospective, and single-blind clinical study will be conducted on 60 patients diagnosed with bruxism. Patients will be divided into three groups: Dry Needling (n=20), Nabota (n=20), and Dysport (n=20). Pain levels will be assessed using the Visual Analog Scale (VAS) at baseline, 1st month, and 3rd month. Muscle thicknesses will be measured using ultrasonography (USG) at baseline and 3rd month. Data distribution will be analyzed using the Kolmogorov-Smirnov test; intergroup comparisons will be performed using ANOVA and Post-hoc Duncan tests.
Results:The results will be analyzed following the completion of the 3-month follow-up period

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Dry Needling Group	Experimental	Procedure: Dry Needling (DN)Patients in this group received deep dry needling treatment. The procedure was performed once a week for a total of three sessions. Sterile needles (0.25x25 mm) were applied to myofascial trigger points in the masseter and anterior temporal muscles.
PraBotulinumtoxinA	Experimental	Drug: PrabotulinumtoxinAPatients received a single-session injection of 50 Units (U) of PrabotulinumtoxinA. The total dose was distributed bilaterally as 15U for each masseter muscle (at 3 points) and 10U for each anterior temporal muscle (at 2 points).
AbobotulinumtoxinA	Experimental	Drug: AbobotulinumtoxinaPatients received a single-session injection of approximately 167 Units (U) of AbobotulinumtoxinA. The total dose was distributed bilaterally as 50U for each masseter muscle (at 3 points) and approximately 33U for each anterior temporal muscle (at 2 points).

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Patients aged 18-65 years diagnosed with "Probable Bruxism". ASA I or ASA II physical status. Patients with severe pain, defined as a score of 8 or higher on a 0-10 Visual Analogue Scale (VAS) (where 0 = no pain and 10 = worst possible pain).

Key exclusion criteria (1 listed)

Allergy to botulinum toxin, silver, or gold. Pregnancy, neuromuscular diseases, or bleeding disorders. Previous TMJ surgery or current use of other treatments.

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
Dry Needling (DN)Deep dry needling application to the masseter and anterior temporal muscles. The procedure was performed in 3 sessions with one-week intervals.	Procedure or surgery	Dry Needling Group
PrabotulinumtoxinAInjection of PrabotulinumtoxinA. A total of 50 Units was administered: 15 Units per masseter muscle and 10 Units per anterior temporal muscle, injected bilaterally in a single session.	Drug	PraBotulinumtoxinA
AbobotulinumtoxinaInjection of AbobotulinumtoxinA. A total of 500 Units (reconstituted to approximately 167 Units for equivalence) was administered: 50 Units per masseter muscle and 33.3 Units per anterior temporal muscle, injected bilaterally in a single session.	Drug	AbobotulinumtoxinA

Primary outcome

Pain Intensity Measured by Visual Analog Scale (VAS)
Time frame: Baseline, 1 month, and 3 months.
Self-reported pain intensity on a scale from 0 (no pain) to 10 (worst imaginable pain). Measurements were taken at baseline, 1 month, and 3 months post-treatment.
Masseter and Anterior Temporal Muscle Thickness Via Ultrasonography (USG)
Time frame: 3rd month post-treatment.
Measurement of the thickness of the masseter and anterior temporal muscles in millimeters (cm) using a high-frequency linear probe. Measurements are taken bilaterally both at rest and during maximum voluntary contraction (clenching).

Results and safety

Results posted to the registry on 20 May 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Dry Needling Group	24	22
PraBotulinumtoxinA	24	23
AbobotulinumtoxinA	24	24

Primary outcome: Pain Intensity Measured by Visual Analog Scale (VAS)

Time frame: Baseline, 1 month, and 3 months.. Mean (Standard Deviation). Unit: VAS score (0-10)

Measure	Dry Needling Group n = 22	PraBotulinumtoxinA n = 23	AbobotulinumtoxinA n = 24
VAS score at 0 month	8.909 (0.426)	8.957 (0.367)	9.167 (0.565)
VAS score at 1 month	1.591 (0.734)	0.957 (0.638)	0.417 (0.584)
VAS score at 3 month	5.182 (1.402)	2.348 (1.301)	2.417 (1.139)

Primary outcome: Masseter and Anterior Temporal Muscle Thickness Via Ultrasonography (USG)

Time frame: 3rd month post-treatment.. Mean (Standard Deviation). Unit: cm

Measure	Dry Needling Group n = 22	PraBotulinumtoxinA n = 23	AbobotulinumtoxinA n = 24
left masseter relaxed	0,770 (0,186)	0,732 (0,234)	0,702 (0,173)
left masseter contracted	1,192 (0,212)	1,101 (0,209)	0,996 (0,155)
Left temporalis relaxed	0,359 (0,092)	0,303 (0,079)	0,297 (0,052)
Left temporalis contracted	0,489 (0,136)	0,421 (0,113)	0,394 (0,070)
Right masseter relaxed	0,750 (0,133)	0,736 (0,205)	0,717 (0,124)
Right masseter contracted	1,186 (0,162)	1.06 (0,271)	1.02 (0,141)
Right temporalis relaxed	0,358 (0,101)	0,314 (0,074)	0,289 (0,050)
Right temporalis contracted	0,475 (0,147)	0,423 (0,096)	0,385 (0,070)

Adverse events

Time frame: From treatment administration to the end of the 3-month follow-up period.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Dry Needling Group	0 of 22 (0%)	0 of 22 (0%)	0 of 22
PraBotulinumtoxinA	0 of 23 (0%)	0 of 23 (0%)	0 of 23
AbobotulinumtoxinA	0 of 24 (0%)	0 of 24 (0%)	0 of 24

Limitations and caveats (from the sponsor): This study has several limitations. First, it was conducted in a single center with a relatively small sample size, which may limit the generalizability of the results. Second, the follow-up period was limited to 3 months, preventing evaluation of long-term effects. Third, the study was single-blinded, which may introduce measurement bias. Additionally, pain assessment using VAS is subjective, and ultrasonographic measurements may be operator-dependent.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No. The individual participant data will not be shared to protect participant privacy, in accordance with the ethical approval obtained for this study.

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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.

Emre BALABAN principal investigator

Assoc. Prof.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Dry Needling (DN), PrabotulinumtoxinA and Abobotulinumtoxina in people with Bruxism and Sleep Bruxism, Adult, run by Recep Tayyip Erdogan 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 1 inclusion and 1 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 20 May 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?

Yes. Results are posted in the registry (first posted 20 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 Measured by Visual Analog Scale (VAS) (time frame: Baseline, 1 month, and 3 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?

On the ClinicalTrials.gov record for NCT07452510.

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 20 May 2026.