Burning Mouth Syndrome
Conditions
Keywords
saliva, pain, markers
Brief summary
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).
Detailed description
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).
Interventions
COMBINATION_PRODUCTLaser+clonazepam
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
DEVICELaser Sham
INACTIVE Helbo® Theralite Laser 3D Pocket Probe low power diode laser once a week for a month
DEVICELaser
Active Helbo® Theralite Laser 3D Pocket Probe low power diode laser once a week for a month
DRUGClonazepam
Rivotril 0.25mg once every 24 hours for a month
Sponsors
Universidad de Murcia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Patients who were included in Group 1 (n=20) were treated with the low power diode laser Helbo® Theralite Laser 3D Pocket Probe once a week for one month and Rivotril 0.25mg once every 24 hours for one month. Group 2 (n=19) were treated with the same laser once a week for one month, but with the tip not activated as a placebo treatment. Group 3 (n=21) were only treated with Helbo® laser once a week for one month and Group 4 (n=18) had only Rivotril 0.25mg once a day for one month. The patients were not aware of the different groups on which this study is based.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain EVA | Baseline through 1 month | The intensity of the symptoms was rated using a Visual Analog Scale (VAS) where 0=no pain and 10=maximum possible pain. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| salivary biomarkers | Baseline through 1 month | salivary biomarkers interleukins (IL2, IL4, IL5, IL6, IL7, IL8, IL1β) |
Countries
Spain
Outcome results
None listed