Burning Mouth Syndrome - New Diagnostic Criteria and Treatment (BMS)
Primary Purpose
Burning Mouth Syndrome
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Clonazepam 0.5 MG
Capsaicin Topical
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Burning Mouth Syndrome focused on measuring BMS, Chronic pain, Pain-related disability, Somatosensory changes, clonazepam, capsaicin, oral mucosa
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Placebo Comparator
Arm Label
Clonazepam
Capsaicin
Placebo
Arm Description
Topical treatment of oral mucosa with a 3-min lozenge tablet with clonazepam (0.5 mg), three times a day.
Topical treatment of oral mucosa with capsaicin rinsing solution (XXXX IE) for three min three times a day.
Topical treatment of oral mucosa with rinsing solution without capsaicin for three min three times a day.
Outcomes
Primary Outcome Measures
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
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
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
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.
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.
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.
Secondary Outcome Measures
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
Full Information
NCT ID
NCT05059418
First Posted
August 31, 2021
Last Updated
September 19, 2021
Sponsor
Malmö University
Collaborators
Lund University
1. Study Identification
Unique Protocol Identification Number
NCT05059418
Brief Title
Burning Mouth Syndrome - New Diagnostic Criteria and Treatment
Acronym
BMS
Official Title
Burning Mouth Syndrome - Optimized Diagnostic Criteria and Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 1, 2021 (Anticipated)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Malmö University
Collaborators
Lund University
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burning Mouth Syndrome
Keywords
BMS, Chronic pain, Pain-related disability, Somatosensory changes, clonazepam, capsaicin, oral mucosa
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
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).
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
One clinical examinator for all examinations (baseline examination, outcome assessments), randomization, allocation and drug management by another person,
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Clonazepam
Arm Type
Active Comparator
Arm Description
Topical treatment of oral mucosa with a 3-min lozenge tablet with clonazepam (0.5 mg), three times a day.
Arm Title
Capsaicin
Arm Type
Active Comparator
Arm Description
Topical treatment of oral mucosa with capsaicin rinsing solution (XXXX IE) for three min three times a day.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Topical treatment of oral mucosa with rinsing solution without capsaicin for three min three times a day.
Intervention Type
Drug
Intervention Name(s)
Clonazepam 0.5 MG
Other Intervention Name(s)
Iktorivil
Intervention Description
Topical treatment of oral mucosa with lozenge pill
Intervention Type
Drug
Intervention Name(s)
Capsaicin Topical
Other Intervention Name(s)
Chili
Intervention Description
Topical treatment of oral mucosa with capsaicin rinse
Intervention Type
Other
Intervention Name(s)
Placebo
Other Intervention Name(s)
Inget
Intervention Description
Mouth rinse with no capsaicin
Primary Outcome Measure Information:
Title
Pain intensity
Description
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
Time Frame
Point measurement, will be assessed immediately before start of treatment
Title
Pain intensity
Description
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
Time Frame
Point measurement, will be assessed 10 days after treatment start for each treatment period.
Title
Pain intensity
Description
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
Time Frame
Point measurement, will be assessed the day after each treatment period is finished (22 days after start of each treatment)
Title
Patient satisfaction
Description
Patient satisfaction with the treatment tested. Will be assessed using a numerical rating scale 0 - 10 where 0 = very dissatisfied and 10 = very satisfied.
Time Frame
Point measurement, will be assessed immediately before start of treatment
Title
Patient satisfaction
Description
Patient satisfaction with the treatment tested. Will be assessed using a numerical rating scale 0 - 10 where 0 = very dissatisfied and 10 = very satisfied.
Time Frame
Point measurement, will be assessed 10 days after treatment start for each treatment period.
Title
Patient satisfaction
Description
Patient satisfaction with the treatment tested. Will be assessed using a numerical rating scale 0 - 10 where 0 = very dissatisfied and 10 = very satisfied.
Time Frame
Point measurement, will be assessed the day after each treatment period is finished (22 days after start of each treatment)
Secondary Outcome Measure Information:
Title
Pain-related disability
Description
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
Time Frame
Point measurement, will be assessed immediately before start of treatment as well as one, two and three weeks after treatment start.
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Per Alstergren, PhD, Prof
Phone
+46406657000
Email
per.alstergren@mau.se
First Name & Middle Initial & Last Name or Official Title & Degree
Thomas List, PhD, Prof
Phone
+46406657000
Email
thomas.list@mau.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Per Alstergren, PhD, Prof
Organizational Affiliation
Malmö University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
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Burning Mouth Syndrome - New Diagnostic Criteria and Treatment
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