Clinical trial NCT05059418: Burning Mouth Syndrome - New Diagnostic Criteria and Treatment
Official title: Burning Mouth Syndrome - Optimized Diagnostic Criteria and Treatment
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Burning Mouth Syndrome
Keywords: BMS
Chronic pain
Pain-related disability
Somatosensory changes
clonazepam
capsaicin
oral mucosa
Lead sponsor: Malmö University
Sponsor class: OTHER
Collaborators: name: Lund University
First posted: 2021-09-28
Enrollment: 40
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: 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 purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Pain intensity
timeFrame: Point measurement, will be assessed immediately before start of treatment
measure: Pain intensity
timeFrame: Point measurement, will be assessed 10 days after treatment start for each treatment period.
measure: Pain intensity
timeFrame: Point measurement, will be assessed the day after each treatment period is finished (22 days after start of each treatment)
measure: Patient satisfaction
timeFrame: Point measurement, will be assessed immediately before start of treatment
measure: Patient satisfaction
timeFrame: Point measurement, will be assessed 10 days after treatment start for each treatment period.
measure: Patient satisfaction
timeFrame: Point measurement, will be assessed the day after each treatment period is finished (22 days after start of each treatment)
Secondary outcomes:
measure: Pain-related disability
timeFrame: Point measurement, will be assessed immediately before start of treatment as well as one, two and three weeks after treatment start.
Other outcomes:
Locations:
Study officials:
affiliation: Malmö University
name: Per Alstergren, PhD, Prof
role: PRINCIPAL_INVESTIGATOR
References: