Burning Mouth Syndrome - New Diagnostic Criteria and Treatment (BMS)

Malmö University

Status: Not yet enrolling

Conditions: Burning Mouth Syndrome

Treatments: Drug: Clonazepam 0.5 MG; Other: Placebo; Drug: Capsaicin Topical

Study type: Interventional

Funder types: Other

Identifiers

NCT05059418

BMS001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: Female

Ages: 30 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Triple Blind

---

40 participants in 3 patient groups, including a placebo group

Clonazepam

Active Comparator group

Description:

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

Treatment:

Drug: Clonazepam 0.5 MG

Capsaicin

Active Comparator group

Description:

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

Treatment:

Drug: Capsaicin Topical

Placebo

Placebo Comparator group

Description:

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

Treatment:

Other: Placebo