Burning Mouth Syndrome - New Diagnostic Criteria and Treatment

Burning Mouth Syndrome Clinical Trial

— BMS  

Official title:

Burning Mouth Syndrome - Optimized Diagnostic Criteria and Treatment

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05059418
• Other study ID #: BMS001
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 1, 2021
• Est. completion date: June 30, 2024

Study information

• Verified date: September 2021
• Source: Malmö University
• Contact: Per Alstergren, PhD, Prof
• Phone: +46406657000
• Email: per.alstergren[@]mau.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: June 30, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 30 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Burning Mouth Syndrome
• Burns
• Syndrome

Intervention

Drug:
• Clonazepam 0.5 MG
Topical treatment of oral mucosa with lozenge pill
• Capsaicin Topical
Topical treatment of oral mucosa with capsaicin rinse

Other:
• Placebo
Mouth rinse with no capsaicin

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Malmö University	Lund University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain intensity	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	Point measurement, will be assessed immediately before start of treatment
Primary	Pain intensity	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	Point measurement, will be assessed 10 days after treatment start for each treatment period.
Primary	Pain intensity	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	Point measurement, will be assessed the day after each treatment period is finished (22 days after start of each treatment)
Primary	Patient satisfaction	Patient satisfaction with the treatment tested. Will be assessed using a numerical rating scale 0 - 10 where 0 = very dissatisfied and 10 = very satisfied.	Point measurement, will be assessed immediately before start of treatment
Primary	Patient satisfaction	Patient satisfaction with the treatment tested. Will be assessed using a numerical rating scale 0 - 10 where 0 = very dissatisfied and 10 = very satisfied.	Point measurement, will be assessed 10 days after treatment start for each treatment period.
Primary	Patient satisfaction	Patient satisfaction with the treatment tested. Will be assessed using a numerical rating scale 0 - 10 where 0 = very dissatisfied and 10 = very satisfied.	Point measurement, will be assessed the day after each treatment period is finished (22 days after start of each treatment)
Secondary	Pain-related disability	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	Point measurement, will be assessed immediately before start of treatment as well as one, two and three weeks after treatment start.