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

Burning Mouth Syndrome - Optimized Diagnostic Criteria and Treatment

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Burning Mouth Syndrome
• Intervention / Treatment: Drug: Clonazepam 0.5 MG; Drug: Capsaicin Topical; Other: Placebo

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.

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Per Alstergren, PhD, Prof; Phone Number: +46406657000; Email: per.alstergren@mau.se
• Study Contact Backup: Name: Thomas List, PhD, Prof; Phone Number: +46406657000; Email: thomas.list@mau.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 28 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Clonazepam; 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; Topical treatment of oral mucosa with lozenge pill; Other Names: Iktorivil
Active Comparator: Capsaicin; Topical treatment of oral mucosa with capsaicin rinsing solution (XXXX IE) for three min three times a day.	Drug: Capsaicin Topical; Topical treatment of oral mucosa with capsaicin rinse; Other Names: Chili
Placebo Comparator: Placebo; Topical treatment of oral mucosa with rinsing solution without capsaicin for three min three times a day.	Other: Placebo; Mouth rinse with no capsaicin; Other Names: Inget

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: Malmö University
• Collaborators: Lund University
• Investigators: Principal Investigator: Per Alstergren, PhD, Prof, Malmo university

Study record dates

Study Major Dates

• Study Start (Anticipated): November 1, 2021
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): June 30, 2024

Study Registration Dates

• First Submitted: August 31, 2021
• First Submitted That Met QC Criteria: September 19, 2021
• First Posted (Actual): September 28, 2021

Study Record Updates

• Last Update Posted (Actual): September 28, 2021
• Last Update Submitted That Met QC Criteria: September 19, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: Chronic pain; BMS; capsaicin; clonazepam; Pain-related disability; Somatosensory changes; oral mucosa
• Additional Relevant MeSH Terms: Pathologic Processes; Wounds and Injuries; Disease; Stomatognathic Diseases; Mouth Diseases; Syndrome; Burns; Burning Mouth Syndrome; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Sensory System Agents; Dermatologic Agents; GABA Modulators; GABA Agents; Anticonvulsants; Antipruritics; Capsaicin; Clonazepam
• Other Study ID Numbers: BMS001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No