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Burning Mouth Syndrome - New Diagnostic Criteria and Treatment

NCT05059418 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2021-09-28

No results posted yet for this study

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.

Conditions

  • Burning Mouth Syndrome

Interventions

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

Sponsors & Collaborators

  • Lund University

    collaborator OTHER

  • Malmö University

    lead OTHER

Principal Investigators

  • Per Alstergren, PhD, Prof · Malmö University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
SEQUENTIAL

Eligibility

Min Age
30 Years
Max Age
80 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-01
Primary Completion
2023-12-31
Completion
2024-06-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05059418 on ClinicalTrials.gov