Burning Mouth Syndrome - New Diagnostic Criteria and Treatment

NCT05059418 | Unknown

• 1 other identifier: BMS001
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Burning Mouth Syndrome

Keywords

BMS; Chronic pain; Pain-related disability; Somatosensory changes; clonazepam; capsaicin; oral mucosa

Outcome Measures

Primary Outcomes (6)

• 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

• 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.

• 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)

• 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

• 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.

• 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 Outcomes (1)

• Pain-related disability

  Point measurement, will be assessed immediately before start of treatment as well as one, two and three weeks after treatment start.

Study Arms (3)

Clonazepam

ACTIVE COMPARATOR

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

Drug: Clonazepam 0.5 MG

Capsaicin

ACTIVE COMPARATOR

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

Drug: Capsaicin Topical

Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

Clonazepam 0.5 MG DRUG

Topical treatment of oral mucosa with lozenge pill

Also known as: Iktorivil

Clonazepam

Capsaicin Topical DRUG

Topical treatment of oral mucosa with capsaicin rinse

Also known as: Chili

Capsaicin

Placebo OTHER

Mouth rinse with no capsaicin

Also known as: Inget

Placebo

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of primary BMS according to International Classification of Orofacial Pain (ICOP) OR diagnosis of other oral mucosal pains according to ICOP

You may not qualify if:

• Fibromyalgia
• IBS
• Reflux
• Recent (\<3 months) intraoral surgical procedure
• Ongoing medication with Clonazepam or Capsaicin

Sponsors & Collaborators

• Malmö University: lead
• Lund University: collaborator

MeSH Terms

Conditions

Burning Mouth Syndrome; Chronic Pain

Interventions

Clonazepam; Capsaicin

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzodiazepinones; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Polyunsaturated Alkamides; Amides; Organic Chemicals; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Solanaceous Alkaloids; Alkaloids; Fatty Acids, Monounsaturated; Fatty Acids, Unsaturated; Fatty Acids; Lipids

Study Officials

• Per Alstergren, PhD, Prof

  Malmö University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Per Alstergren, PhD, Prof

CONTACT

+46406657000; per.alstergren@mau.se

Thomas List, PhD, Prof

CONTACT

+46406657000; thomas.list@mau.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: One clinical examinator for all examinations (baseline examination, outcome assessments), randomization, allocation and drug management by another person,
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Pro Dean

Model Details: 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).

Study Record Dates

• First Submitted: August 31, 2021
• First Posted: September 28, 2021
• Study Start: November 1, 2021
• Primary Completion: December 31, 2023
• Study Completion: June 30, 2024
• Last Updated: September 28, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share