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Effect of Treatments on Pain and Quality of Life in Individual With Burning Mouth Syndrome

Primary Purpose

Burning Mouth Syndrome

Status
Not yet recruiting
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
topical placebo tablet
topical clonazepam tablet
oral alpha-lipoic acid capsule
topical phytotherapic capsaicin gel
local photobiomodulation
Sponsored by
Federal University of Minas Gerais
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Burning Mouth Syndrome

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: burning mouth syndrome; oral pain that recurs daily for > 2 hours per day for > 3 months; pain with burning quality and felt superficially in the oral mucosa; oral mucosa appears normal oral clinical examination, including sensory tests, is normal; Exclusion Criteria: pregnancy; oral mucosal lesions; systemic diseases such as diabetes, anemia, deficiency of vitamin B1, B2, B6, B12, Fe, Zinc, and folic acid; gastroesophageal reflux; previous head and neck radiotherapy; Sjogren's disease; allergies; candidiasis; unstimulated saliva flow < 0.25 ml/min and stimulated flow < 1.0 ml/min will be excluded;

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm 5

    Arm 6

    Arm Type

    Placebo Comparator

    No Intervention

    Experimental

    Experimental

    Experimental

    Experimental

    Arm Label

    topical placebo tablet

    control

    topical clonazepam tablet

    oral alpha-lipoic acid capsule

    topical phytotherapic capsaicin gel

    local photobiomodulation

    Arm Description

    magnesium silicate placebo tablet three times a day for 21 days

    artificial saliva

    2.0 mg Clonazepam tablet three times a day for 21 days

    300 mg alpha-lipoic acid capsule twice a day for 60 days

    0.025 mg capsaicin gel 4 times a day for 14 days

    Photobiomodulation with wavelength of 810 nm, power of 0.6 W, power density of 1.2 W/cm², beam area of 0.5 cm², and energy of 6 J.

    Outcomes

    Primary Outcome Measures

    Change in pain scores
    Change in pain scores measured by a visual analog scale and the short version of the McGill Pain Questionnaire. Visual Analogue Scale: values ranging from 0 (no pain) to 10 (most severe pain). The McGill instrument contains 15 descriptors of pain sensation (11 sensory and 4 affective), with each descriptor ranked on a 4-point rating scale (0 = none, 1 = mild, 2 = moderate and 3 = severe). Three measures of pain experience based on sensory and affective descriptors can be obtained: (1) The total index consists of the sum of all 15 descriptors with the total score ranging from 0 to 45; (2) The sensory index consists of the sum of descriptors 1 - 11 with the total score ranging from 0 to 33; and (3) the affective index consists of the sum of descriptors 12 - 15 with the total score ranging from 0 to 12.
    Change in pain scores
    Change in pain scores measured by a visual analog scale and the short version of the McGill Pain Questionnaire. Visual Analogue Scale: values ranging from 0 (no pain) to 10 (most severe pain). The McGill instrument contains 15 descriptors of pain sensation (11 sensory and 4 affective), with each descriptor ranked on a 4-point rating scale (0 = none, 1 = mild, 2 = moderate and 3 = severe). Three measures of pain experience based on sensory and affective descriptors can be obtained: (1) The total index consists of the sum of all 15 descriptors with the total score ranging from 0 to 45; (2) The sensory index consists of the sum of descriptors 1 - 11 with the total score ranging from 0 to 33; and (3) the affective index consists of the sum of descriptors 12 - 15 with the total score ranging from 0 to 12.

    Secondary Outcome Measures

    Change in quality of life scores
    Change in quality of life measured by Oral Impacts on Daily Performance scores. Total score ranging from 0 to 275 being classified as: 0 = no impact, values 1 to 10 = low impact, values 11 to 40 = medium impact and values 41 to 275 = high impact (i.e, worse quality of life).
    Change in quality of life scores
    Change in quality of life measured by Oral Impacts on Daily Performance scores. Total score ranging from 0 to 275 being classified as: 0 = no impact, values 1 to 10 = low impact, values 11 to 40 = medium impact and values 41 to 275 = high impact (i.e, worse quality of life).

    Full Information

    First Posted
    September 10, 2023
    Last Updated
    October 9, 2023
    Sponsor
    Federal University of Minas Gerais
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06040190
    Brief Title
    Effect of Treatments on Pain and Quality of Life in Individual With Burning Mouth Syndrome
    Official Title
    Evaluation of the Effect of Different Treatments on Pain Scores and Self-reported Oral Health-related Quality of Life in Individuals With Burning Mouth Syndrome: a Randomized Controlled Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    November 1, 2023 (Anticipated)
    Primary Completion Date
    June 1, 2024 (Anticipated)
    Study Completion Date
    October 1, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Federal University of Minas Gerais

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Burning Mouth Syndrome (BMS) is characterized by a burning sensation on the tongue or other areas of the mouth, often bilateral but occasionally unilateral. It is more prevalent in postmenopausal women. No specific ethnic or socioeconomic predisposition has been identified. The etiology and pathophysiology of BMS remain unknown. Various treatment approaches have been proposed, yielding conflicting outcomes and underscoring the need for further investigation. Patients with BMS appear to respond well to long-term therapy involving systemic antidepressants and anxiolytics. The most promising therapeutic effects have been observed with clonazepam, which leads to a significant reduction in pain when applied topically or systemically. Capsaicin, an herbal remedy, also presents as an alternative treatment option, showing positive results in alleviating BMS symptoms when compared to a placebo. Photobiomodulation represents another non-pharmacological treatment possibility. It's analgesic action is possibly attributed to the inhibition of pain mediators. Alpha-lipoic acid (ALA) is dietary supplement employed in BMS treatment. It serves as a potent antioxidant naturally produced within the body, contributing to the mitigation of skin aging and reinforcing the effects of other biological antioxidants. Based on these findings, attempts have been made to demonstrate ALA's effectiveness in BMS management, concluding that ALA may offer benefits in this context. Therefore, the objective of this study is to investigate, in adults with BMS, the impact of different therapeutic approaches on frequency, intensity, and location of pain, as well as on on quality of life.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Burning Mouth Syndrome

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    150 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    topical placebo tablet
    Arm Type
    Placebo Comparator
    Arm Description
    magnesium silicate placebo tablet three times a day for 21 days
    Arm Title
    control
    Arm Type
    No Intervention
    Arm Description
    artificial saliva
    Arm Title
    topical clonazepam tablet
    Arm Type
    Experimental
    Arm Description
    2.0 mg Clonazepam tablet three times a day for 21 days
    Arm Title
    oral alpha-lipoic acid capsule
    Arm Type
    Experimental
    Arm Description
    300 mg alpha-lipoic acid capsule twice a day for 60 days
    Arm Title
    topical phytotherapic capsaicin gel
    Arm Type
    Experimental
    Arm Description
    0.025 mg capsaicin gel 4 times a day for 14 days
    Arm Title
    local photobiomodulation
    Arm Type
    Experimental
    Arm Description
    Photobiomodulation with wavelength of 810 nm, power of 0.6 W, power density of 1.2 W/cm², beam area of 0.5 cm², and energy of 6 J.
    Intervention Type
    Drug
    Intervention Name(s)
    topical placebo tablet
    Other Intervention Name(s)
    magnesium silicate
    Intervention Description
    Individuals will be instructed to dissolve half a tablet of placebo medication and hold the saliva near the painful oral sites without swallowing, for 3 minutes and then spit. Tablets will contain magnesium silicate, with the same color and flavor as the test medications. Researchers will provide a total of 32 tablets for each participant.
    Intervention Type
    Drug
    Intervention Name(s)
    topical clonazepam tablet
    Intervention Description
    Individuals will be instructed to dissolve half a tablet of clonazepam and hold the saliva near the painful oral sites without swallowing for 3 minutes and then spit. Researchers will provide a total of 32 tablets for each participant.
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    oral alpha-lipoic acid capsule
    Intervention Description
    Participants in this group will be instructed to take oral capsules containing alpha-lipoic acid.
    Intervention Type
    Other
    Intervention Name(s)
    topical phytotherapic capsaicin gel
    Intervention Description
    Participants in this group will to apply the gel containing tocapsaicin on painful oral sites.
    Intervention Type
    Radiation
    Intervention Name(s)
    local photobiomodulation
    Other Intervention Name(s)
    photodynamic therapy
    Intervention Description
    Photobiomodulation will be applied during 10 seconds per point at 56 points (three on the vestibular mucosa of the 4 quadrants, four on each labial mucosa, six on each of the two buccal mucosae, six on the hard palate, four on each lateral edge of the tongue, six on the dorsum of the tongue, and four sublingual points) with an intermediate distance of 2 mm. A dose of 12 J/cm² per session will be applied in continuous mode for 10 sessions. The 10 sessions will be applied twice a week for 5 consecutive weeks. The LASER will be applied perpendicularly in contact with the mucosa. All patients and the clinician will wear protective glasses.
    Primary Outcome Measure Information:
    Title
    Change in pain scores
    Description
    Change in pain scores measured by a visual analog scale and the short version of the McGill Pain Questionnaire. Visual Analogue Scale: values ranging from 0 (no pain) to 10 (most severe pain). The McGill instrument contains 15 descriptors of pain sensation (11 sensory and 4 affective), with each descriptor ranked on a 4-point rating scale (0 = none, 1 = mild, 2 = moderate and 3 = severe). Three measures of pain experience based on sensory and affective descriptors can be obtained: (1) The total index consists of the sum of all 15 descriptors with the total score ranging from 0 to 45; (2) The sensory index consists of the sum of descriptors 1 - 11 with the total score ranging from 0 to 33; and (3) the affective index consists of the sum of descriptors 12 - 15 with the total score ranging from 0 to 12.
    Time Frame
    baseline and 3 weeks
    Title
    Change in pain scores
    Description
    Change in pain scores measured by a visual analog scale and the short version of the McGill Pain Questionnaire. Visual Analogue Scale: values ranging from 0 (no pain) to 10 (most severe pain). The McGill instrument contains 15 descriptors of pain sensation (11 sensory and 4 affective), with each descriptor ranked on a 4-point rating scale (0 = none, 1 = mild, 2 = moderate and 3 = severe). Three measures of pain experience based on sensory and affective descriptors can be obtained: (1) The total index consists of the sum of all 15 descriptors with the total score ranging from 0 to 45; (2) The sensory index consists of the sum of descriptors 1 - 11 with the total score ranging from 0 to 33; and (3) the affective index consists of the sum of descriptors 12 - 15 with the total score ranging from 0 to 12.
    Time Frame
    baseline and 2 months
    Secondary Outcome Measure Information:
    Title
    Change in quality of life scores
    Description
    Change in quality of life measured by Oral Impacts on Daily Performance scores. Total score ranging from 0 to 275 being classified as: 0 = no impact, values 1 to 10 = low impact, values 11 to 40 = medium impact and values 41 to 275 = high impact (i.e, worse quality of life).
    Time Frame
    baseline and 3 weeks
    Title
    Change in quality of life scores
    Description
    Change in quality of life measured by Oral Impacts on Daily Performance scores. Total score ranging from 0 to 275 being classified as: 0 = no impact, values 1 to 10 = low impact, values 11 to 40 = medium impact and values 41 to 275 = high impact (i.e, worse quality of life).
    Time Frame
    baseline and 2 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: burning mouth syndrome; oral pain that recurs daily for > 2 hours per day for > 3 months; pain with burning quality and felt superficially in the oral mucosa; oral mucosa appears normal oral clinical examination, including sensory tests, is normal; Exclusion Criteria: pregnancy; oral mucosal lesions; systemic diseases such as diabetes, anemia, deficiency of vitamin B1, B2, B6, B12, Fe, Zinc, and folic acid; gastroesophageal reflux; previous head and neck radiotherapy; Sjogren's disease; allergies; candidiasis; unstimulated saliva flow < 0.25 ml/min and stimulated flow < 1.0 ml/min will be excluded;
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Fernando O Costa, PhD
    Phone
    +55 31 9954-0657
    Email
    focperio@uol.com.br
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Fernando O Costa, PhD
    Organizational Affiliation
    Federal University of Minas Gerais
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    Individual patient data will not be shared.

    Learn more about this trial

    Effect of Treatments on Pain and Quality of Life in Individual With Burning Mouth Syndrome

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