NCT06217731

Inflammatory Markers in Saliva of Patients With Burning Mouth Syndrome

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Universidad de Murcia · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Burning Mouth Syndrome

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Laser+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
DEVICE	Laser Sham	INACTIVE Helbo® Theralite Laser 3D Pocket Probe low power diode laser once a week for a month
DEVICE	Laser	Active Helbo® Theralite Laser 3D Pocket Probe low power diode laser once a week for a month
DRUG	Clonazepam	Rivotril 0.25mg once every 24 hours for a month

Timeline

• Start date: 2022-01-10
• Primary completion: 2022-02-10
• Completion: 2023-12-10
• First posted: 2024-01-22
• Last updated: 2024-07-31

Locations

1 site across 1 country: Spain