- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06217731
Inflammatory Markers in Saliva of Patients With Burning Mouth Syndrome (burningmouth)
Inflammatory Markers in Saliva of Patients With Burning Mouth Syndrome Before and After Treatment With Low-Level Laser Therapy and Clonazepam: A Randomized, Single-Blind Clinical Trial
Burning Mouth Syndrome (BMS) is a chronic pain disorder that presents with inflammation and burning sensation in the oral cavity without visible lesions. Multiple therapies have been investigated without conclusive results.Objective: To analyse the efficacy of treatment with Clonazepam (Rivotril) and Low Power Diode Laser Therapy in patients with Burning Mouth Syndrome and to study the markers of inflammation present in the patients' saliva.
Methods: Randomised, single-blind clinical trial with 89 patients divided into Group 1 Laser + Rivotril (n=20), Group 2 Laser Sham placebo (n=19), Group 3 Laser (n=21) and Group 4 Rivotril (n=18). The intensity of symptomatology was rated by Visual Analogue Scale (VAS). Sialometry was performed before and after treatment and questionnaires such as the Xerostomia Inventory, the Oral Health Impact Profile-14 (OHIP14) and the Mini-Nutritional Assessment (MNA) were completed. Saliva samples were analysed by measuring markers related to inflammatory processes; Interleukins (IL2, IL4, IL 5, IL6, IL 7, IL 8, IL1β, IL 10, IL12, IL13, IL17, IL21, IL23), proteins (MIP-3α, MIP-1α, MIP-1β), Cytokine GM-CSF, Interferon gamma (IFNγ), Interferon Inducible Tα-Cell Chemoattractant (ITAC), Fractalkine and Tumour Necrosis Factor α(TNFα).
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Murcia, Spain, 30004
- Pia Lopez Jornet
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Clinical diagnosis Burning Mouth Syndrome (BMS) burning sensation in the oral mucosa or recurrent dysesthetics daily for more than 2 hours a day for more than 3 months, without clinically evident causal lesions
Exclusion Criteria:
- Pregnant or lactating patients
- Oncology patients
- Sjögren's syndrome
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Active Comparator: Group1 laser + clonazepam
Group 1 (n=20) were treated with the Helbo® Theralite Laser 3D Pocket Probe low power diode laser once a week for a month and Rivotril ( clonazepam) 0.25mg once every 24 hours for a month.
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treated with the Helbo® Theralite Laser 3D Pocket Probe low power diode laser once a week for a month and Rivotril 0.25mg once every 24 hours for a month
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Sham Comparator: group2 Laser Sham
Group 2 (n=19) were treated with the same laser once a week for a month, but with the tip deactivated
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INACITVE Helbo® Theralite Laser 3D Pocket Probe low power diode laser once a week for a month
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Experimental: group4 clonazepam
Group 4 (n=18) were treated with Rivotril 0.25mg once a day for a month.
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Rivotril 0.25mg once every 24 hours for a month
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Experimental: group3 laser
Group 3 (n=21) were treated with the Helbo® laser once a week for a month.
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Active Helbo® Theralite Laser 3D Pocket Probe low power diode laser once a week for a month
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain EVA
Time Frame: Baseline through 1 month
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The intensity of the symptoms was rated using a Visual Analog Scale (VAS) where 0=no pain and 10=maximum possible pain.
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Baseline through 1 month
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
salivary biomarkers
Time Frame: Baseline through 1 month
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salivary biomarkers interleukins (IL2, IL4, IL5, IL6, IL7, IL8, IL1β)
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Baseline through 1 month
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Liu YF, Kim Y, Yoo T, Han P, Inman JC. Burning mouth syndrome: a systematic review of treatments. Oral Dis. 2018 Apr;24(3):325-334. doi: 10.1111/odi.12660. Epub 2017 Mar 30.
- Tan HL, Smith JG, Hoffmann J, Renton T. A systematic review of treatment for patients with burning mouth syndrome. Cephalalgia. 2022 Feb;42(2):128-161. doi: 10.1177/03331024211036152. Epub 2021 Aug 18.
- Alvarenga-Brant R, Costa FO, Mattos-Pereira G, Esteves-Lima RP, Belem FV, Lai H, Ge L, Gomez RS, Martins CC. Treatments for Burning Mouth Syndrome: A Network Meta-analysis. J Dent Res. 2023 Feb;102(2):135-145. doi: 10.1177/00220345221130025. Epub 2022 Oct 8.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pia Lopez Jornet
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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