Inflammatory Markers in Saliva of Patients With Burning Mouth Syndrome (burningmouth)

U

Universidad de Murcia

Status

Completed

Conditions

Burning Mouth Syndrome

Treatments

Combination Product: Laser+clonazepam
Device: Laser Sham
Drug: Clonazepam
Device: Laser

Study type

Interventional

Funder types

Other

Identifiers

NCT06217731
Pia Lopez Jornet

Details and patient eligibility

About

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).

Full 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).

Enrollment

20 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

20 participants in 4 patient groups

Group1 laser + clonazepam
Active Comparator group
Description:
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.
Treatment:
Combination Product: Laser+clonazepam
group2 Laser Sham
Sham Comparator group
Description:
Group 2 (n=19) were treated with the same laser once a week for a month, but with the tip deactivated
Treatment:
Device: Laser Sham
group3 laser
Experimental group
Description:
Group 3 (n=21) were treated with the Helbo® laser once a week for a month.
Treatment:
Device: Laser
group4 clonazepam
Experimental group
Description:
Group 4 (n=18) were treated with Rivotril 0.25mg once a day for a month.
Treatment:
Drug: Clonazepam

Trial contacts and locations

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Data sourced from clinicaltrials.gov

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