Burning Mouth Syndrome - New Diagnostic Criteria and Treatment

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-01

Study Completion Date

2024-06-30

Brief Summary

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The first part of this study is to optimize diagnostic criteria for BMS, i.e. not a clinical trial, and will not be covered in this application.

The second part will compare topical treatment with clonazepam, capsaicin and placebo in a n-of-1 study design regarding effects of pain, pain-related disability, somatosensory changes in the trigeminal nerve and patient experience in patients with primary BMS or other oral mucosal pain. The patients will be treated for two weeks with each drug, with a one-week wash-out period in between. After the last washed-out period, the patients will be able to chose the treatment that they prefer the most and continue with that treatment during 6 months.

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Detailed Description

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The clinical trial in the present study will investigate treatment effects on pain, pain-related disability, jaw function and patients' experiences by topical treatment with clonazepam or capsaicin in comparison with placebo in patients with BMS or other oral mucosal pain.

Twenty patients with primary BMS and 20 patients with other oral mucosal pain will be included. The study will comprise a n-of-1-design where each participant will be it's own control.

The study will compare topical treatment with clonazepam, capsaicin and placebo regarding effects of pain, pain-related disability, somatosensory changes in the trigeminal nerve and patient experience. primary outcome will be pain intensity and patient experience.

The patients will be treated for two weeks with each drug, with a one-week wash-out period in between. After the last washed-out period, the patients will be able to chose the treatment that they prefer the most and continue with that treatment during 6 months. After this 6 months, pain, pain-related disability, somatosensory changes in the trigeminal nerve and patient experience will be assessed again.

Conditions

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Burning Mouth Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

N-of-1 design. Three two-week treatment arms with a one-week wash-out period in between. After that, the patient will chose their preferred treatment and continue with that treatment for 6 months (i.e. this part is not randomized or controlled).

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

One clinical examinator for all examinations (baseline examination, outcome assessments), randomization, allocation and drug management by another person,

Study Groups

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Clonazepam

Topical treatment of oral mucosa with a 3-min lozenge tablet with clonazepam (0.5 mg), three times a day.

Group Type ACTIVE_COMPARATOR

Clonazepam 0.5 MG

Intervention Type DRUG

Topical treatment of oral mucosa with lozenge pill

Capsaicin

Topical treatment of oral mucosa with capsaicin rinsing solution (XXXX IE) for three min three times a day.

Group Type ACTIVE_COMPARATOR

Capsaicin Topical

Intervention Type DRUG

Topical treatment of oral mucosa with capsaicin rinse

Placebo

Topical treatment of oral mucosa with rinsing solution without capsaicin for three min three times a day.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Mouth rinse with no capsaicin

Interventions

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Clonazepam 0.5 MG

Topical treatment of oral mucosa with lozenge pill

Intervention Type DRUG

Capsaicin Topical

Topical treatment of oral mucosa with capsaicin rinse

Intervention Type DRUG

Placebo

Mouth rinse with no capsaicin

Intervention Type OTHER

Other Intervention Names

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Iktorivil Chili Inget

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of primary BMS according to International Classification of Orofacial Pain (ICOP) OR diagnosis of other oral mucosal pains according to ICOP