Comparison Between Two Treatments for Burning Mouth

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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COMPARATIVE ANALYSIS OF THE TREATMENT OF BURNING MOUTH WITH LOW-INTENSITY LASER THERAPY AND TRANSCUTANEOUS ELECTRICAL NERVOUS STIMULATION: RANDOMIZED CLINICAL TRIAL

Conditions
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Burning Mouth Syndrome

Intervention / Treatment
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* Device: Low-Level Light Therapy
* Device: Transcutaneous Electric Nerve Stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients over 18 years of age who had a 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, but who did not present clinical alterations in the oral mucosa such as erosive lichen planus, geographic tongue, infections, allergic reactions, trauma and injuries by physical or chemical agents. - Exclusion Criteria: patients who did not comply with the study treatment protocol.

Ages Eligible for Study
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Minimum Age: 41 Years
Maximum Age: 77 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Grupo TENS<br>Participants with burning mouth underwent to transcutaneous electrical nerve stimulation | Device: Transcutaneous Electric Nerve Stimulation<br>* 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.<br>|
| Active Comparator: Grupo LLLT<br>Participants with burning mouth underwent low-level laser therapy | Device: Low-Level Light Therapy<br>* 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.<br>* Other names: Low Power Laser Therapy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptoms | Improvement of symptoms, determined by Visual Analogue Scale (VAS) (0-10 cm) before the beginning of treatment, with one month of treatment, with two months of treatment and 30 days after the end of treatment. | Three months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Salivary flow | Increase in salivary flow, determined by collecting unstimulated salivary flow before starting treatment, at one month of treatment, at two months of treatment and 30 days after the end of treatment. | Three months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Low-Level Light Therapy, Transcutaneous Electric Nerve Stimulation