Inflammatory Markers in Saliva of Patients With Burning Mouth Syndrome
NCT ID: NCT06217731
Last Updated: 2024-07-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
20 participants
INTERVENTIONAL
2022-01-10
2023-12-10
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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).
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Low Level Laser Therapy Plus Topical Clonazepam Treatment to Burning Mouth Symdrome
NCT04313907
Effect of Treatments on Pain and Quality of Life in Individual With Burning Mouth Syndrome
NCT06040190
Evaluation of the Effectiveness of the Selected Method of Treatment of Primary Burning Mouth Syndrome
NCT04884503
Effects of Photobiomodulation in Burning Mouth Syndrome
NCT04034849
Effectiveness of Mucolox® and Clonazepam in Treatment of Burning Mouth Syndrome
NCT02690844
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Group1 laser + clonazepam
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.
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
group 2 Laser Sham
Group 2 (n=19) were treated with the same laser once a week for a month, but with the tip deactivated
Laser Sham
INACTIVE Helbo® Theralite Laser 3D Pocket Probe low power diode laser once a week for a month
group3 laser
Group 3 (n=21) were treated with the Helbo® laser once a week for a month.
Laser
Active Helbo® Theralite Laser 3D Pocket Probe low power diode laser once a week for a month
group 4 clonazepam
Group 4 (n=18) were treated with Rivotril 0.25mg once a day for a month.
Clonazepam
Rivotril 0.25mg once every 24 hours for a month
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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
Laser Sham
INACTIVE Helbo® Theralite Laser 3D Pocket Probe low power diode laser once a week for a month
Laser
Active Helbo® Theralite Laser 3D Pocket Probe low power diode laser once a week for a month
Clonazepam
Rivotril 0.25mg once every 24 hours for a month
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
* Oncology patients
* Sjögren's syndrome
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Universidad de Murcia
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Pia Lopez Jornet
Principal investigator
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Pia Lopez Jornet
Murcia, , Spain
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Pia Lopez Jornet
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.