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Botox vs. mouthguards: which eases grinding pain best?

NCT ID NCT07586072

Symptom relief Sponsor: Recep Tayyip Erdogan University 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 31, 2026 · Updated 2 times

Summary

This study tested three ways to treat jaw pain caused by teeth grinding (bruxism): a custom mouthguard (occlusal splint), Botox injections, or both together. Sixty adults completed the 3-month trial. Researchers measured pain and jaw function changes to see which approach worked best.

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 (Dysport)
What this could lead to
If successful, this could show which treatment—splint, Botox, or both—works best for easing jaw pain and clenching symptoms.
What could go wrong
This is a small, non-randomized study, so results may not apply to everyone. Botox injections can cause temporary muscle weakness or bruising.

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.

Participants

60 people

The number who actually took part.

Started

Aug 2024

Finished

Aug 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.

Who is studied

The study population consisted of adults presenting to the Department of Prosthodontics, Faculty of Dentistry, Recep Tayyip Erdoğan University, with reported clenching or grinding and temporomandibular disorder related symptoms. Eligible participants who met the predefined inclusion and exclusion criteria were included during the study period and were managed according to routine clinical indication, symptom profile, shared decision making, and patient preference.

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. * Presence of bruxism-related temporomandibular disorder symptoms. * Self-reported sleep or awake bruxism based on clenching or grinding awareness. * Clinical signs compatible with bruxism, including dental attrition, cupped-out wear facets, or shiny occlusal surfaces. * Absence of known systemic conditions that could interfere with treatment or outcome assessment. * Ability to provide written informed consent. Exclusion Criteria: * Age younger than 18 years. * Presence of systemic or neurological disorders. * Uncontrolled psychiatric conditions. * Infection or inflammatory lesions at the planned injection sites. * History of maxillofacial surgery or severe trauma in the relevant orofacial region. * Inability or unwillingness to provide written informed consent.

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Conditions

The condition(s) this trial relates to.

bruxism myofascial pain syndrome temporomandibular joint disorder

As listed by the trial registrant

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

Bruxism Myofascial pain Temporomandibular disorders (TMD)

Contacts and locations

Locations

  • Recep Tayyip Erdogan University Faculty of Dentistry

    Rize, Rize Province, 53020, Turkey (Türkiye)

More trials for these conditions

Other studies related to the condition(s) this trial covers.