Burning Mouth Syndrome - New Diagnostic Criteria and Treatment

Not Applicable

• Conditions: Burning Mouth Syndrome
• Interventions: Drug: Capsaicin Topical; Other: Placebo; Drug: Clonazepam 0.5 MG

• Registration Number: NCT05059418
• Lead Sponsor: Malmö University

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2021-08-31
• Status Verified: 2021-09
• Study First Submitted QC: 2021-09-19
• Last Update Submitted: 2021-09-19
• Study First Posted: 2021-09-28
• Last Update Posted: 2021-09-28
• Study Start: 2021-11-01
• Primary Completion: 2023-12-31
• Study Completion: 2024-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 40

Inclusion Criteria

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

Exclusion Criteria

• Fibromyalgia
• IBS
• Reflux
• Recent (<3 months) intraoral surgical procedure
• Ongoing medication with Clonazepam or Capsaicin

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Capsaicin	Capsaicin Topical	Topical treatment of oral mucosa with capsaicin rinsing solution (XXXX IE) for three min three times a day.
Placebo	Placebo	Topical treatment of oral mucosa with rinsing solution without capsaicin for three min three times a day.
Clonazepam	Clonazepam 0.5 MG	Topical treatment of oral mucosa with a 3-min lozenge tablet with clonazepam (0.5 mg), three times a day.

Primary Outcome Measures

Name	Time	Method
Pain intensity	Point measurement, will be assessed the day after each treatment period is finished (22 days after start of each treatment)	Overall oral mucosa pain intensity. Will be assessed using the subscale "Characteristic pain intensity" (three numerical rating scales 0 - 10 assessing current pain. intensity as well as worst and average pain intensity during the last two weeks) in the Graded Chronic Pain Scale
Patient satisfaction	Point measurement, will be assessed the day after each treatment period is finished (22 days after start of each treatment)	Patient satisfaction with the treatment tested. Will be assessed using a numerical rating scale 0 - 10 where 0 = very dissatisfied and 10 = very satisfied.

Secondary Outcome Measures

Name	Time	Method
Pain-related disability	Point measurement, will be assessed immediately before start of treatment as well as one, two and three weeks after treatment start.	Pain-related disability from oral mucosal pains. Will be assessed using the subscale "Pain-related Disability" (three numerical rating scales 0 - 10 assessing impact on the oral pain on general, social and work-related activities during the last two weeks) in the Graded Chronic Pain Scale