Burning Mouth SyndromePBM-BMSNCT05871580
Effect to the Photobiomodulation in the Burning Mouth Syndrome
A study testing Low frequency laser activated photobiomodulation and Low frequency laser photobiomodulation inactive in people with Burning Mouth Syndrome and Quality of Life, run by University of Santiago de Compostela at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Burning Mouth Syndrome, Quality of Life, Anxiety Depression
- What is being tested?
- Low frequency laser activated photobiomodulation and Low frequency laser photobiomodulation inactive
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- 12 May 2023to 15 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Universidad de Santiago de Compostela
Santiago de Compostela, A Coruña, 15785
About this study
Official title: 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.
Read more
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
- Being tested
- Low frequency laser activated photobiomodulation, Low frequency laser photobiomodulation inactive
- Keywords
- Burning Mouth Syndrome, Oral Manifestations, Quality of Life, Anxiety Depression, Hyposalivation, Xerostomia
- Medical subject headings
- Burning Mouth Syndrome, Xerostomia, Oral Manifestations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low frequency laser activated photobiomodulationRadiation
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 inactiveOther
The same protocol as the activated group
| Study group | Role | What they receive |
|---|---|---|
| Laser Group (GL) | Active comparator | The patients will be submitted to eight sessions of low power laser. The radiation emission will be performed according to the protocol. Receives: Radiation: Low frequency laser activated photobiomodulation |
| Control Group (CG) | Placebo comparator | 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. Receives: Other: Low frequency laser photobiomodulation inactive |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (4)
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.
Measured: 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.
Measured: 6 months
Subjective sensation of dry mouth
Assess the subjective sensation of dry mouth through the xerostomia inventory.
Measured: 6 months
Quantitative measurement of saliva
Quantitative measurement of saliva through the unstimulated global saliva test (TSG-I).
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2023
- Study start12 May 2023
- Primary completion30 Oct 2023
- Study completion15 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Burning Mouth SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Santiago de Compostela
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mario Pérez Sayáns, University of Santiago de Compostela
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05871580
- Sponsor's protocol ID
- RCT-PBM/BMS-23
- Acronym
- PBM-BMS
- Status last verified
- Apr 2024
- First submitted
- 12 May 2023
- Last updated
- 18 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The investigators will anonymize and categorize the clinical data of the patients to share the information with the other researchers of the group.
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect to the Photobiomodulation in the Burning Mouth Syndrome. A Randomised Doble-Blind Clinical Trial.
- ClinicalTrials.gov ID
- NCT05871580
- Acronym / sponsor ID
- PBM-BMS / RCT-PBM/BMS-23
- Conditions
- Burning Mouth Syndrome, Quality of Life, Anxiety Depression, Dry Mouth
- Keywords
- Burning Mouth Syndrome, Oral Manifestations, Quality of Life, Anxiety Depression, Hyposalivation, Xerostomia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of Santiago de CompostelaUniversity, hospital or other
- Study start
- 12 May 2023 (actual)
- Primary completion
- 30 Oct 2023 (actual)
- Study completion
- 15 Jan 2024 (actual)
- First posted
- 23 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laser Group (GL) | Active comparator | Radiation: Low frequency laser activated photobiomodulationThe patients will be submitted to eight sessions of low power laser. The radiation emission will be performed according to the protocol. |
| Control Group (CG) | Placebo comparator | Other: Low frequency laser photobiomodulation inactiveIn 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low frequency laser activated photobiomodulationInfravermelho: 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. | Radiation | Laser Group (GL) |
| Low frequency laser photobiomodulation inactiveThe same protocol as the activated group | Other | Control Group (CG) |
Primary outcome
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.
4 secondary outcomes
Degree of anxiety of the patients
Time frame: 6 months
Quality of life of the patients
Time frame: 6 months
Subjective sensation of dry mouth
Time frame: 6 months
Quantitative measurement of saliva
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2024.
- Individual participant dataSharing planned: Undecided. The investigators will anonymize and categorize the clinical data of the patients to share the information with the other researchers of the group.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low frequency laser activated photobiomodulation and Low frequency laser photobiomodulation inactive in people with Burning Mouth Syndrome and Quality of Life, run by University of Santiago de Compostela at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain reported (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2024.