Skip to main content
OpenTrials
Completed

NCT Number: NCT05871580

Effect to the Photobiomodulation in the Burning Mouth Syndrome

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidad de Santiago de Compostela

Santiago de Compostela, A Coruña, 15785, Spain

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with a diagnosis of BMS and symptoms of at least 3 months duration;
  • Clinical examination confirms clinically normal mucosa;
  • Patients who are not undergoing treatment for BMS;
  • Patients who, after being informed about the objectives and procedures of the investigation, agree and sign the informed consent form.

Exclusion criteria

  • Patients with uncontrolled systemic diseases (ASA III, IV);
  • Patients who have received previous radio and/or chemotherapy of the head and neck;
  • Patients with secondary BMS, which is due to organic causes, such as biological factors, i.e. the presence of some bacteria or fungi, which have a direct irritant effect on the oral mucosa and are capable of triggering burning symptoms. Such conditions considered as differential diagnosis of primary BMS which are, oral candidiasis, erosive lichen planus, geographic tongue;
  • Patients presenting systemic factors such as Sjögren's syndrome, untreated diabetes, or if they use drugs that cause oral burning;
  • Patients presenting a VAS score below 3 out of 10.

Removal criteria:

-Patients who for any reason fail to keep follow-up appointments.

Treatment and study plan

Low frequency laser activated photobiomodulation

Radiation

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.

Low frequency laser photobiomodulation inactive

Other

The same protocol as the activated group

Primary outcomes

  1. Pain reported

    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.

Secondary outcomes

  1. Degree of anxiety of the patients

    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.

  2. Quality of life of the patients

    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.

  3. Subjective sensation of dry mouth

    Time frame: 6 months

    Assess the subjective sensation of dry mouth through the xerostomia inventory.

  4. Quantitative measurement of saliva

    Time frame: 6 months

    Quantitative measurement of saliva through the unstimulated global saliva test (TSG-I).

Sponsors and collaborators

Lead sponsor

University of Santiago de Compostela

Other

Registry information

Official study title

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

Acronym: PBM-BMS

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
May 23, 2023
Registry last updated
Apr 18, 2024

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.