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Botox for grinding teeth: does it change jaw muscle over time?

NCT ID NCT07266064

Knowledge-focused Sponsor: Melek Volkan Yazici Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at 27 adults with sleep bruxism (teeth grinding) who got Botox injections in their jaw muscles every six months for two years. Researchers used ultrasound to measure fat buildup in the muscle before each injection. The goal was to see if repeated Botox causes long-term structural changes in the jaw muscle.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
botulinum toxin type A (Botox)
What this could lead to
If it works, this could help doctors understand the long-term safety of repeated Botox injections for teeth grinding.
What could go wrong
This is a small, completed study with only 27 people, so results may not apply to everyone. It looks at muscle changes, not whether the treatment works for symptoms.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

27 people

The number who actually took part.

Started

Jan 2024

Finished

Nov 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Adults aged 18 years or older. * Clinical diagnosis of probable sleep bruxism according to the international consensus criteria proposed by Lobbezoo et al. * Indication for BoNT-A injection in the masseter muscle due to bruxism-related pain or muscle hypertrophy. * Willingness to undergo repeated BoNT-A injections at six-month intervals. * Willingness to participate in ultrasonographic evaluations at each follow-up visit. Exclusion Criteria: * Presence of neurological or neuromuscular disorders affecting the masticatory muscles (e.g., dystonia, myasthenia gravis). * History of orofacial trauma, temporomandibular joint dysfunction, or maxillofacial surgery. * Systemic diseases that may affect neuromuscular transmission or muscle metabolism. * Use of medications known to interfere with neuromuscular function, including aminoglycoside antibiotics or corticosteroids.

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Conditions

The condition(s) this trial relates to.

bruxism parasomnia, sleep bruxism type Sleep Bruxism

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Bruxism Bruxism, sleep Bruxism, sleep-related

Contacts and locations

Locations

  • Ankara University, Faculty of Dentistry

    Ankara, Cankaya, 06560, Turkey (Türkiye)

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