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Study on Clonazepam for Treating Burning Mouth Syndrome in Patients

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a condition known as Burning Mouth Syndrome (BMS). BMS is a condition characterized by a burning sensation in the mouth without an obvious cause. The treatment being investigated in this study is a medication called Clonazepam, which is typically used to treat seizures and panic disorders. In this trial, Clonazepam will be applied topically, meaning it will be used directly on the affected area in the mouth, rather than being taken as a pill.

The purpose of the study is to explore the effects of this topical treatment on pain intensity, sensory changes, and jaw function in individuals with BMS. The study will be conducted in two parts. The first part will last for two weeks, during which participants will use the topical Clonazepam treatment. Researchers will assess how the treatment affects pain and other symptoms, as well as gather feedback on the participants' experiences with the treatment. The second part involves a long-term follow-up over six months, where participants will continue with either Clonazepam or a control treatment, chosen without knowing which one they are receiving. This follow-up will help understand the long-term effects of the treatment.

Throughout the study, various aspects will be monitored, including changes in pain levels, any sensory changes such as taste, and how the condition affects daily activities. The study aims to provide insights into how effective topical Clonazepam is in managing the symptoms of Burning Mouth Syndrome and to understand the participants' overall impression of the treatment.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, the diagnosis of burning mouth syndrome (BMS) is confirmed according to the International Classification of Orofacial Pain.

    Eligibility is determined based on specific criteria related to BMS.

  2. Step 2

    Initial assessment

    An initial assessment of pain intensity is conducted. This involves evaluating the overall oral mucosa pain using a scale from 0 to 10.

    The assessment includes current pain, worst pain, and average pain over the last two weeks.

  3. Step 3

    First study phase

    The first phase involves a two-week treatment with clonazepam applied topically.

    The focus is on understanding the effect of the treatment on pain intensity, sensory changes, and jaw function.

    Patient preferences and experiences with the treatment are also recorded.

  4. Step 4

    Follow-up assessments

    Pain intensity is reassessed one, two, and three weeks after the start of treatment.

    Additional assessments include changes in taste, jaw function limitations, stress levels, and pain-related disability.

  5. Step 5

    Long-term follow-up

    A long-term follow-up is conducted over six months.

    Participants choose their preferred treatment, either clonazepam or a control, without knowing which they are receiving.

    All factors examined in the first study phase are reassessed during this period.

  6. Step 6

    Final evaluation

    The final evaluation includes a comprehensive assessment of pain intensity, patient global impression of change, and any pain-related disability.

    The study concludes with a review of the long-term effects of the treatment.

Who can join the trial?

5 criteria

  • The patient must have a **diagnosis** of **Burning Mouth Syndrome (BMS)**. This is a condition that causes a burning sensation in the mouth.
  • The patient must be diagnosed according to the **International Classification of Orofacial Pain (ICOP)**. This is a system used by doctors to classify and diagnose pain in the face and mouth area.
  • The patient must be within the age range of **18 to 64 years old**.
  • Both **male and female** patients are eligible to participate.
  • The patient should not belong to a **vulnerable population**. This means they should not be in a group that needs special protection, like children or people with certain disabilities.
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Investigated drugs

Clonazepam is being studied as a topical treatment for burning mouth syndrome. The trial aims to see how clonazepam affects pain intensity, sensory changes, and jaw function in patients. The study will also look at patients' preferences and experiences with the treatment over a two-week period. Additionally, there will be a long-term follow-up to assess the effects of clonazepam over six months.

What is already known about the treatment

Clonazepam – Clonazepam is administered topically in this clinical trial, specifically for the treatment of burning mouth syndrome. It is currently being studied for its effectiveness in reducing pain intensity and improving jaw function in affected patients. The medication is primarily indicated for its potential to alleviate symptoms associated with burning mouth syndrome. At the molecular level, clonazepam works by enhancing the activity of neurotransmitters in the brain, which helps to reduce nerve-related pain. It is classified pharmacologically as a benzodiazepine, known for its calming effects on the nervous system.

Investigated diseases

Burning Mouth Syndrome – Burning Mouth Syndrome is a condition characterized by a persistent burning sensation in the mouth, often affecting the tongue, lips, gums, or palate. The exact cause is not well understood, but it may be related to nerve damage or hormonal changes. Symptoms can include a dry mouth, altered taste, and a feeling of tingling or numbness. The discomfort can vary in intensity and may worsen throughout the day. It is more common in middle-aged or older women. The condition can be chronic, lasting for months or even years.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-509727-40-00Estimated enrolment30 patientsSponsorMalmoe Universitet

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