Effect to the Photobiomodulation in the Burning Mouth Syndrome (PBM-BMS)

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

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.

Study Overview

• Status: Completed
• Conditions: Quality of Life; Anxiety Depression; Dry Mouth; Burning Mouth Syndrome
• Intervention / Treatment: Other: Low frequency laser photobiomodulation inactive; Radiation: Low frequency laser activated photobiomodulation

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • A Coruña
    • Santiago De Compostela, A Coruña, Spain, 15785
      • Universidad de Santiago de Compostela

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Control Group (CG); In these patients the investigators will use the same protocol applied in the experimental group (time and application values) but the laser device will be turn off.	Other: Low frequency laser photobiomodulation inactive; The same protocol as the activated group
Active Comparator: Laser Group (GL); The patients will be submitted to eight sessions of low power laser. The radiation emission will be performed according to the protocol.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain reported	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.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subjective sensation of dry mouth	Assess the subjective sensation of dry mouth through the xerostomia inventory.	6 months
Quantitative measurement of saliva	Quantitative measurement of saliva through the unstimulated global saliva test (TSG-I).	6 months
Degree of anxiety of the patients	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.	6 months
Quality of life of the patients	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.	6 months

Collaborators and Investigators

• Sponsor: University of Santiago de Compostela

Study record dates

Study Major Dates

• Study Start (Actual): May 12, 2023
• Primary Completion (Actual): October 30, 2023
• Study Completion (Actual): January 15, 2024

Study Registration Dates

• First Submitted: May 12, 2023
• First Submitted That Met QC Criteria: May 12, 2023
• First Posted (Actual): May 23, 2023

Study Record Updates

• Last Update Posted (Actual): April 18, 2024
• Last Update Submitted That Met QC Criteria: April 17, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Quality of Life; Xerostomia; Burning Mouth Syndrome; Hyposalivation; Oral Manifestations; Anxiety Depression
• Additional Relevant MeSH Terms: Behavioral Symptoms; Pathologic Processes; Wounds and Injuries; Disease; Stomatognathic Diseases; Mouth Diseases; Depression; Syndrome; Burns; Burning Mouth Syndrome
• Other Study ID Numbers: RCT-PBM/BMS-23

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: The investigators will anonymize and categorize the clinical data of the patients to share the information with the other researchers of the group.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No