NCT05059418

Burning Mouth Syndrome - New Diagnostic Criteria and Treatment

Burning Mouth Syndrome - Optimized Diagnostic Criteria and Treatment

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Malmö University · Academic / Other
• Sex: Female
• Age: 30 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Burning Mouth Syndrome

Interventions

Type	Name	Description
DRUG	Clonazepam 0.5 MG	Topical treatment of oral mucosa with lozenge pill
DRUG	Capsaicin Topical	Topical treatment of oral mucosa with capsaicin rinse
OTHER	Placebo	Mouth rinse with no capsaicin

Timeline

• Start date: 2021-11-01
• Primary completion: 2023-12-31
• Completion: 2024-06-30
• First posted: 2021-09-28
• Last updated: 2021-09-28