Universidad de Santiago de Compostela
Santiago de Compostela, A Coruña, 15785, Spain
NCT Number: NCT05871580
Introduction: Burning mouth syndrome (BMS) is a pathology with a low prevalence, affecting between 0.1% and 3.7% of the general population, the ratio between women and men is between 3 and 7:1. It is clinically characterized by a burning pain sensation, recurrent daily for more than 2 hours a day, persistent for more than 3 months and in a way that increases throughout the day and decreases at night, without presenting clinically evident causal lesions on the surface of the oral mucosa, nor changes in clinical sensory tests.
The description of the symptomatology varies according to the patient and may be related especially to psychogenic factors.
Patients report dry mouth/xerostomia and taste alterations, such as metallic or bitter taste. The most frequent location is on the tongue (tip and lateral borders), but it can also include the anterior palate, gingiva and lips.
Since the etiopathogenic factors that produce BMS are not clear, it is difficult to make advances in therapy. The available treatments aim to control the multiple factors related to BMS, thus reducing the symptoms described by patients. Among them, the literature describes low level laser photobiomodulation.
The success of the use of low level lasers for treatments in oral medicine is due to their biomodulatory activity and their ability to penetrate tissues. The analgesic action of laser radiation is due to the inhibition of nociceptive mediators and the release by the Central Nervous System (CNS) of endogenous analgesic substances such as endorphins, which hinders the transmission of the painful stimulus.
It has been verified that low power laser radiation therapy can be effective in reducing symptoms in patients with BMS. Importantly, low power laser therapy is non-invasive, well tolerated by patients.
Objectives: To confirm the hypothesis that the application of low power laser in the areas of oral burning can improve the symptomatology of BMS.
Material and methods: We propose a clinical study in 38 patients with idiopathic BMS, prospective, randomized, double-blind.
The study universe will be constituted by patients attended at the Oral Medicine, Oral Surgery and Implantology Unit of the Faculty of Dentistry of the University of Santiago de Compostela (USC).
The Hospital Anxiety and Depression Scale (HADS), quality of life (OHIP-14) and subjective sensation of dry mouth xerostomia inventory (XI) questionnaires will be applied to all the patients, and the amount of saliva will be quantitatively determined by means of the unstimulated global saliva test (TSG-I) using a millimetric absorbent paper strip, at the beginning, at the end of treatment and at the re-evaluation at two and six months.
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Not applicable
Santiago de Compostela, A Coruña, 15785, Spain
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Removal criteria:
-Patients who for any reason fail to keep follow-up appointments.
Infravermelho: analgesia, tissue biostimulation. The number of laser application points will be determined based on the areas referred by the patients.
Time of 30 seconds in each application point, with dosage: 3 J/point.
The same protocol as the activated group
Time frame: 6 months
To evaluate the effect of 808 nm diode laser radiation (infrared) applied intraorally on areas where patients report burning mouth. The degree of pain/burning reported by patients using a visual analogue scale (VAS). Scale from 0 to 10, where zero means no pain and ten means severe pain.
Time frame: 6 months
To evaluate the degree of anxiety of the patients, through the Hospital Anxiety and Depression Scale (HADS). For every question the patient must answer about the presence or frequency of the symptoms, with four possible answers. The score ranges from 0 to 3 points for every question, depending on the intensity of the symptoms. Therefore, the total HADS score ranges from 0 to 21 points for each subscale.
Time frame: 6 months
Assess quality of life, using OHIP-14. For scoring the answers to each of the 14 questions in the OHIP-14, the following values are used: 0 = never, 1 = rarely, 2 = sometimes, 3 = frequently, 4 = always, with the maximum possible score reaching 56 points.
Time frame: 6 months
Assess the subjective sensation of dry mouth through the xerostomia inventory.
Time frame: 6 months
Quantitative measurement of saliva through the unstimulated global saliva test (TSG-I).
University of Santiago de Compostela
Other
Effect to the Photobiomodulation in the Burning Mouth Syndrome. A Randomised Doble-Blind Clinical Trial.
Acronym: PBM-BMS
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT04535973
17β-Estradiol, Burning Mouth Syndrome
Zagreb, Croatia
View Trial DetailsNCT01754740
Burning Mouth Syndrome, Mouth Diseases
São Paulo, Brazil
View Trial DetailsNCT00001601
Aphthous Stomatitis, Burning Mouth Syndrome
Bethesda, Maryland, United States
View Trial DetailsNCT07344909
Burning Mouth Syndrome, Facial Pain
Malmö, Sweden
View Trial Details