Inflammatory Markers in Saliva of Patients With Burning Mouth Syndrome

NCT06217731 | Completed

• 1 other identifier: Pia Lopez Jornet
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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).

Conditions

Burning Mouth Syndrome

Keywords

saliva; pain; markers

Outcome Measures

Primary Outcomes (1)

• Pain EVA

  The intensity of the symptoms was rated using a Visual Analog Scale (VAS) where 0=no pain and 10=maximum possible pain.

  Baseline through 1 month

Secondary Outcomes (1)

• salivary biomarkers

  Baseline through 1 month

Study Arms (4)

Group1 laser + clonazepam

ACTIVE COMPARATOR

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 Laser Sham

SHAM COMPARATOR

Group 2 (n=19) were treated with the same laser once a week for a month, but with the tip deactivated

Device: Laser Sham

group3 laser

EXPERIMENTAL

Group 3 (n=21) were treated with the Helbo® laser once a week for a month.

Device: Laser

group 4 clonazepam

EXPERIMENTAL

Group 4 (n=18) were treated with Rivotril 0.25mg once a day for a month.

Drug: Clonazepam

Interventions

Laser+clonazepam COMBINATION_PRODUCT

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

Group1 laser + clonazepam

Laser Sham DEVICE

INACTIVE Helbo® Theralite Laser 3D Pocket Probe low power diode laser once a week for a month

group 2 Laser Sham

Laser DEVICE

Active Helbo® Theralite Laser 3D Pocket Probe low power diode laser once a week for a month

group3 laser

Clonazepam DRUG

Rivotril 0.25mg once every 24 hours for a month

group 4 clonazepam

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Pregnant or lactating patients
• Oncology patients
• Sjögren's syndrome

Sponsors & Collaborators

• Universidad de Murcia: lead

Study Sites (1)

Pia Lopez Jornet

Murcia, 30004, Spain

Location

Related Publications (3)

• 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.

  PMID: 34404247 BACKGROUND

• 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.

  PMID: 36214096 BACKGROUND

• 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.

  PMID: 28247977 BACKGROUND

MeSH Terms

Conditions

Burning Mouth Syndrome; Pain

Interventions

Lasers; Clonazepam

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies; Benzodiazepinones; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: January 6, 2024
• First Posted: January 22, 2024
• Study Start: January 10, 2022
• Primary Completion: February 10, 2022
• Study Completion: December 10, 2023
• Last Updated: July 31, 2024

Record last verified: 2024-01

Locations

ES (1)