NCT05871580

Effect to the Photobiomodulation in the Burning Mouth Syndrome

Effect to the Photobiomodulation in the Burning Mouth Syndrome. A Randomised Doble-Blind Clinical Trial.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: University of Santiago de Compostela · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Burning Mouth Syndrome
• Quality of Life
• Anxiety Depression
• Dry Mouth

Interventions

Type	Name	Description
RADIATION	Low frequency laser activated photobiomodulation	Infravermelho: analgesia, tissue biostimulation. The number of laser application points will be determined based on the areas referred by the patients. * apex tongue: 3 points * lateral edge of the tongue: 4 points * tongue dorsum: 10 points * jugal mucosa: 8 points * labial mucosa: 5 points * hard palate: 8 stitches * soft palate: 3 stitches * gingiva or alveolar mucosa: 3 stitches per sextant. Time of 30 seconds in each application point, with dosage: 3 J/point.
OTHER	Low frequency laser photobiomodulation inactive	The same protocol as the activated group

Timeline

• Start date: 2023-05-12
• Primary completion: 2023-10-30
• Completion: 2024-01-15
• First posted: 2023-05-23
• Last updated: 2024-04-18

Locations

1 site across 1 country: Spain