An interventional study of Laser+clonazepam and Laser Sham in Burning Mouth Syndrome, sponsored by Universidad de Murcia. Completed at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-07-31.
Sponsored by Universidad de Murcia · Not applicable, Interventional, and Treatment
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).
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).
44 studies on the registry are indexed under Burning Mouth Syndrome; 6 are open to participants now.
This study's enrollment of 20 is below the median of 42 across 35 interventional studies indexed under Burning Mouth Syndrome.
Browse Burning Mouth Syndrome studies →Universidad de Murcia is the lead sponsor of 77 studies on the registry; 16 are open to participants now.
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Exclusion Criteria:
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.
Combination Product: Laser+clonazepam
Group 2 (n=19) were treated with the same laser once a week for a month, but with the tip deactivated
Device: Laser Sham
Group 3 (n=21) were treated with the Helbo® laser once a week for a month.
Device: Laser
Group 4 (n=18) were treated with Rivotril 0.25mg once a day for a month.
Drug: 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
INACTIVE Helbo® Theralite Laser 3D Pocket Probe low power diode laser once a week for a month
Active Helbo® Theralite Laser 3D Pocket Probe low power diode laser once a week for a month
Rivotril 0.25mg once every 24 hours for a month
Pain EVA
The intensity of the symptoms was rated using a Visual Analog Scale (VAS) where 0=no pain and 10=maximum possible pain.
Time frame: Baseline through 1 month
salivary biomarkers
salivary biomarkers interleukins (IL2, IL4, IL5, IL6, IL7, IL8, IL1β)
Time frame: Baseline through 1 month
Plan to share: Undecided
This study is completed, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.
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Universidad de Murcia