Burning Mouth SyndromeNCT05816200

Comparison Between Two Treatments for Burning Mouth

A study testing Low-Level Light Therapy and Transcutaneous Electric Nerve Stimulation in people with Burning Mouth Syndrome, run by Universidade Federal do Rio Grande do Norte at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 77 yearsHealthy volunteers can take part
Conditions the study is for: Burning Mouth Syndrome
What is being tested?: Low-Level Light Therapy and Transcutaneous Electric Nerve Stimulation
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 28 participants
Where: 1 siteBrazil
Study dates: 1 Apr 2021to 30 Jun 2022
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 to 77 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Patients aged 18 years or over
Patients with burning sensation in the oral mucosa or recurrent dysesthetics daily for more than 2 hours a day for more than 3 months, without clinically evident causal lesions (IHS, 2018) were included in the study, as well as those who presented hyposalivation or some systemic alteration that could be related to a burning sensation in the oral mucosa

Who cannot join

Patients who did not comply with the study treatment protocol.

Trial locations and contacts

1 site in 1 country.

Brazil1 site

Department of Dentistry, Federal University of Rio Grande do Norte
Natal, Rio Grande do Norte, 59056-000

Other trials in Brazil

About this study

Official title: Comparative Analysis of Low-Level Light Therapy and Transcutaneous Electrical Nerve Stimulation for Burning Mouth: a Randomized Clinical Trial

Introduction: The management of patients with chronic burning mouth is a challenge in clinical dentistry. Objective: To compare the effect of Low Level Laser Therapy (LLLT) and Transcutaneous Electrical Nerve Stimulation (TENS) in the treatment of burning mouth. Materials and Methods: Randomized clinical trial consisting of 25 patients with burning mouth who were treated by TENS (n=12) and by LLLT (n=13). Treatment was carried out weekly for 8 weeks. Two-way ANOVA was used to verify whether there was a significant difference between times T0 (baseline), T1 (after the 4th treatment session), T2 (after the 8th treatment session) and T3 (30 days after the end of treatment) in in relation to symptoms, analyzed using the Visual Analog Scale, unstimulated salivary flow, xerostomia and dysgeusia with TENS and LLLT interventions.

Read the detailed description

Experimental group: 20 participants with burning mouth were submitted to transcutaneous electrical nerve stimulation using a device at a frequency of 50 Hertz with intensity modulated according to the patient's comfort ranging from 1 - 4 (pulse amplitude) with a duration of 25 minutes per session, with one session per week, totaling eight weeks of treatment at the end of the study. The device's self-adhesive electrodes were fixed on the participant's face, following the path of the trigeminal nerve branch on the side affected by pain and/or burning.

Control group: 20 participants with burning mouth underwent low power laser therapy with punctual applications of infrared laser (L2) (power of 100mW, 808 nm, 6 joules of energy/60 seconds) in the affected region, keeping one centimeter of distance between the points, until the entire area of the complaint was irradiated. being held one session per week, totaling eight weeks of treatment at the end of the study.

Conditions: Burning Mouth Syndrome
Being tested: Low-Level Light Therapy, Transcutaneous Electric Nerve Stimulation
Keywords: Low-Level Light Therapy, Transcutaneous Electric Nerve Stimulation
Medical subject headings: Burning Mouth Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Low-Level Light TherapyDevice
Also called Low Power Laser Therapy
Punctual applications of infrared laser (L2) (power of 100mW, 808 nm, 6 joules of energy/60 seconds) in the affected region, keeping one centimeter of distance between the points, until the entire area of the complaint was irradiated. being held one session per week, totaling eight weeks of treatment at the end of the study.
Transcutaneous Electric Nerve StimulationDevice
Using a device at a frequency of 50 Hertz with intensity modulated according to the patient's comfort ranging from 1 - 4 (pulse amplitude) with a duration of 25 minutes per session, with one session per week, totaling eight weeks of treatment at the end of the study. The device's self-adhesive electrodes were fixed on the participant's face, following the path of the trigeminal nerve branch on the side affected by pain and/or burning.

Study groups in NCT05816200
Study group	Role	What they receive
Grupo TENS	Experimental	Participants with burning mouth underwent to transcutaneous electrical nerve stimulation Receives: Device: Transcutaneous Electric Nerve Stimulation
Grupo LLLT	Active comparator	Participants with burning mouth underwent low-level laser therapy Receives: Device: Low-Level Light Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

Painful Symptoms
Changes in the intensity of pain/burning was determined by Visual Analogue Scale. Possible scores range from 0 (no pain) to 10 (worst possible pain).
Measured: Baseline (T0), after the 4th treatment session (4 weeks), after the 8th treatment session (8 weeks). ), 30 days after the end of treatment (8 weeks + 30 days).

Secondary outcomes (1)

Salivary Flow
The unstimulated salivary flow rate will be determined by the ratio volume of saliva collected, expressed in millimeters per minute (ml/min).
Measured: Baseline (T0), after the 4th treatment session (4 weeks), after the 8th treatment session (8 weeks). ), 30 days after the end of treatment (8 weeks + 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Apr 202130 Jun 2022

First posted18 Apr 2023
Study start1 Apr 2021
Primary completion3 Dec 2021
Study completion30 Jun 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
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: None (open label)
Enrolment: 28 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05816200
Sponsor's protocol ID: U1111-1274-3207
Other IDs: RBR-7fvcjkz
Status last verified: Jun 2024
First submitted: 3 Apr 2023
Last updated: 21 Jun 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No: The article referring to this clinical trial is being edited for subsequent publication in a journal.

Publications

Arduino PG, Cafaro A, Garrone M, Gambino A, Cabras M, Romagnoli E, Broccoletti R. A randomized pilot study to assess the safety and the value of low-level laser therapy versus clonazepam in patients with burning mouth syndrome. Lasers Med Sci. 2016 May;31(4):811-6. doi: 10.1007/s10103-016-1897-8. Epub 2016 Feb 12.
PubMed 26873501
Medeiros CKS, Serrao MDCPN, de Lima AAS, da Silveira EJD, de Oliveira PT. Comparative analysis of photobiomodulation therapy and transcutaneous electrical nerve stimulation for burning mouth: a randomized clinical trial. Clin Oral Investig. 2023 Oct;27(10):6157-6165. doi: 10.1007/s00784-023-05232-7. Epub 2023 Sep 1.
PubMed 37656286

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
Improving Prescribing Quality for Oral Mucosal Disorders Using a Pharmacist-Led Model
Oral Lichen Planus, Recurrent Aphthous Stomatitis
Recruiting
MucoLock™ for Treatment of Stomatitis
Stomatitis, Pain
RecruitingObservational study
Reducing Patient Memory Recall in the Burning Mouth Patient Population
Burning Mouth Syndrome
Active, not recruiting
Photobiomodulation Therapy vs. Alpha-Lipoic Acid in Burning Mouth Syndrome Treatment
Burning Mouth Syndrome, Low Level Laser Therapy
Not yet recruiting
Burning Mouth Syndrome: Effects of Occlusal Splint Therapy
Burning Mouth Syndrome, Orofacial Pain

All Burning Mouth Syndrome trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparative Analysis of Low-Level Light Therapy and Transcutaneous Electrical Nerve Stimulation for Burning Mouth: a Randomized Clinical Trial
ClinicalTrials.gov ID: NCT05816200
Acronym / sponsor ID: U1111-1274-3207
Conditions: Burning Mouth Syndrome
Keywords: Low-Level Light Therapy, Transcutaneous Electric Nerve Stimulation
Study type: Interventional
Recruitment status: Completed
Enrolment: 28 participants (actual)
Lead sponsor: Universidade Federal do Rio Grande do NorteUniversity, hospital or other
Study start: 1 Apr 2021 (actual)
Primary completion: 3 Dec 2021 (actual)
Study completion: 30 Jun 2022 (actual)
First posted: 18 Apr 2023 (actual)
Results: Posted 21 Jun 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Grupo TENS	Experimental	Device: Transcutaneous Electric Nerve StimulationParticipants with burning mouth underwent to transcutaneous electrical nerve stimulation
Grupo LLLT	Active comparator	Device: Low-Level Light TherapyParticipants with burning mouth underwent low-level laser therapy

Who may qualify

Ages: 18 to 77 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Patients aged 18 years or over
Patients with burning sensation in the oral mucosa or recurrent dysesthetics daily for more than 2 hours a day for more than 3 months, without clinically evident causal lesions (IHS, 2018) were included in the study, as well as those who presented hyposalivation or some systemic alteration that could be related to a burning sensation in the oral mucosa

Key exclusion criteria (1 listed)

Patients who did not comply with the study treatment protocol.

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-Level Light TherapyAlso: Low Power Laser TherapyPunctual applications of infrared laser (L2) (power of 100mW, 808 nm, 6 joules of energy/60 seconds) in the affected region, keeping one centimeter of distance between the points, until the entire area of the complaint was irradiated. being held one session per week, totaling eight weeks of treatment at the end of the study.	Device	Grupo LLLT
Transcutaneous Electric Nerve StimulationUsing a device at a frequency of 50 Hertz with intensity modulated according to the patient's comfort ranging from 1 - 4 (pulse amplitude) with a duration of 25 minutes per session, with one session per week, totaling eight weeks of treatment at the end of the study. The device's self-adhesive electrodes were fixed on the participant's face, following the path of the trigeminal nerve branch on the side affected by pain and/or burning.	Device	Grupo TENS

Primary outcome

Painful Symptoms
Time frame: Baseline (T0), after the 4th treatment session (4 weeks), after the 8th treatment session (8 weeks). ), 30 days after the end of treatment (8 weeks + 30 days).
Changes in the intensity of pain/burning was determined by Visual Analogue Scale. Possible scores range from 0 (no pain) to 10 (worst possible pain).

1 secondary outcome

Salivary Flow
Time frame: Baseline (T0), after the 4th treatment session (4 weeks), after the 8th treatment session (8 weeks). ), 30 days after the end of treatment (8 weeks + 30 days

Results and safety

Results posted to the registry on 21 Jun 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Grupo TENS	14	12
Grupo LLLT	14	13

Primary outcome: Painful Symptoms

Time frame: Baseline (T0), after the 4th treatment session (4 weeks), after the 8th treatment session (8 weeks). ), 30 days after the end of treatment (8 weeks + 30 days).. Mean (Standard Deviation). Unit: score on a scale

Measure	Grupo TENS n = 12	Grupo LLLT n = 13
T0	7.58 (2.64)	6.92 (2.54)
T1	5.08 (2.94)	5.33 (3.23)
T2	3.17 (2.48)	4.50 (2.88)
T3	5.75 (2.49)	3.75 (3.08)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 3 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Grupo LLLT	0 of 14 (0%)	0 of 14 (0%)	0 of 14
Grupo TENS	0 of 14 (0%)	0 of 14 (0%)	0 of 14

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 26873501Arduino PG, Cafaro A, Garrone M, Gambino A, Cabras M, Romagnoli E, Broccoletti R. A randomized pilot study to assess the safety and the value of low-level laser therapy versus clonazepam in patients with burning mouth syndrome. Lasers Med Sci. 2016 May;31(4):811-6. doi: 10.1007/s10103-016-1897-8. Epub 2016 Feb 12.
Derived from this study: PubMed 37656286Medeiros CKS, Serrao MDCPN, de Lima AAS, da Silveira EJD, de Oliveira PT. Comparative analysis of photobiomodulation therapy and transcutaneous electrical nerve stimulation for burning mouth: a randomized clinical trial. Clin Oral Investig. 2023 Oct;27(10):6157-6165. doi: 10.1007/s00784-023-05232-7. Epub 2023 Sep 1.
Individual participant dataSharing planned: No. The article referring to this clinical trial is being edited for subsequent publication in a journal.

Related trials for Burning Mouth Syndrome

Not yet recruiting
Improving Prescribing Quality for Oral Mucosal Disorders Using a Pharmacist-Led Model
Oral Lichen Planus, Recurrent Aphthous Stomatitis
Recruiting
MucoLock™ for Treatment of Stomatitis
Stomatitis, Pain
RecruitingObservational study
Reducing Patient Memory Recall in the Burning Mouth Patient Population
Burning Mouth Syndrome
Active, not recruiting
Photobiomodulation Therapy vs. Alpha-Lipoic Acid in Burning Mouth Syndrome Treatment
Burning Mouth Syndrome, Low Level Laser Therapy
Not yet recruiting
Burning Mouth Syndrome: Effects of Occlusal Splint Therapy
Burning Mouth Syndrome, Orofacial Pain

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.

Patrícia Oliveira, PhD study director

Universidade Federal do Rio Grande do Norte

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-Level Light Therapy and Transcutaneous Electric Nerve Stimulation in people with Burning Mouth Syndrome, run by Universidade Federal do Rio Grande do Norte at 1 site in Brazil.

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 2 inclusion and 1 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 21 Jun 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 Brazil. 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. 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?

Yes. Results are posted in the registry (first posted 21 Jun 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Painful Symptoms (time frame: Baseline (T0), after the 4th treatment session (4 weeks), after the 8th treatment session (8 weeks). ), 30 days after the end of treatment (8 weeks + 30 days).). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05816200, which also lists 2 linked publications.

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 21 Jun 2024.