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Could a botox shot in the mouth silence stubborn nerve pain?

NCT ID NCT03848143

Symptom relief Sponsor: Isabel Moreno Hay 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 30, 2026 · Last updated Jul 31, 2026 · Updated 1 time

Summary

This pilot study is testing whether injecting Botox directly into the painful area inside the mouth can reduce continuous nerve pain in the teeth or jaw. Eight adults with long-lasting dentoalveolar pain that hasn't responded to standard treatments will receive two rounds of injections three months apart. They will track their pain daily using a simple 0-to-10 scale to see if the treatment brings relief.

What this could mean

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

Active substance
onabotulinum toxin A (Botox) injected into the painful area inside the mouth
What this could lead to
If it works, this could offer a new treatment option for people with hard-to-treat nerve pain in the mouth or jaw.
What could go wrong
This is a very small pilot study with only 8 participants, so results may not apply widely. Botox injections can cause temporary weakness or swelling in nearby muscles.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

8 people

The number who actually took part.

Started

Sep 2019

Finished

Jun 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 to 80 years

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: * History of continuous dentoalveolar pain with clinically evident positive (hyperalgesia, allodynia) and/or negative (hypoaesthesia, hypoalgesia) signs of trigeminal nerve dysfunction and where other possible pain sources have been ruled out. * Intractable pain to conventional oral and/or topical pharmacotherapy for neuropathic pain according to the recommendations published by NeuPSIG (Neuropathic Pain Special Interest Group) including anticonvulsants, SNRIs (serotonin and norepinephrine reuptake inhibitors) and/or tricyclic antidepressants. * Subject consent to participate in the study. Exclusion Criteria: * hypersensitive to any onabotulinum toxin preparation or any component in the formulation. * systemic nerve or muscle disorders * bleeding disorders * dysphagia * breathing problems * pregnancy or breastfeeding * previous treatment with botulinum toxin in the last 4 months.

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Conditions

The condition(s) this trial relates to.

neuralgia

As listed by the trial registrant

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

Neuropathic pain

Contacts and locations

Locations

  • Orofacial Pain Center

    Lexington, Kentucky, 40536, United States

More trials for these conditions

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