Burning Mouth Syndrome
Conditions
Keywords
Low-Level Light Therapy, Transcutaneous Electric Nerve Stimulation
Brief summary
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
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.
Interventions
DEVICELow-Level Light 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.
DEVICETranscutaneous Electric 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.
Sponsors
Universidade Federal do Rio Grande do Norte
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 77 Years
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
• Patients who did not comply with the study treatment protocol.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Painful Symptoms | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Salivary Flow | 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 | The unstimulated salivary flow rate will be determined by the ratio volume of saliva collected, expressed in millimeters per minute (ml/min). |
Countries
Brazil
Participant flow
Recruitment details
The study population consisted of patients complaining of burning mouth treated at the Stomatology Service of the Department of Dentistry (DOD) at UFRN from April 2021 to February 2022.
Pre-assignment details
Individuals who presented clinical changes in the oral mucosa such as erosive lichen planus, geographic tongue, infections, allergic reactions, trauma and injuries caused by physical or chemical agents were excluded.
Participants by arm
| Arm | Count |
|---|---|
| Grupo TENS Participants with burning mouth underwent to transcutaneous electrical nerve stimulation
Transcutaneous Electric 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. | 12 |
| Grupo LLLT Participants with burning mouth underwent low-level laser therapy
Low-Level Light 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. | 13 |
| Total | 25 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 2 | 1 |
Baseline characteristics
| Characteristic | Grupo TENS | Grupo LLLT | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 3 Participants | 6 Participants | 9 Participants |
| Age, Categorical Between 18 and 65 years | 9 Participants | 7 Participants | 16 Participants |
| Age, Continuous | 58.36 years STANDARD_DEVIATION 10.56 | 61.36 years STANDARD_DEVIATION 10.4 | 59.86 years STANDARD_DEVIATION 10.4 |
| Painful symptoms | 7.58 units on a scale STANDARD_DEVIATION 2.64 | 6.92 units on a scale STANDARD_DEVIATION 2.54 | 7.39 units on a scale STANDARD_DEVIATION 2.48 |
| Race/Ethnicity, Customized Baseline (T0) Brown | 2 Participants | 6 Participants | 8 Participants |
| Race/Ethnicity, Customized Baseline (T0) White | 10 Participants | 07 Participants | 17 Participants |
| Region of Enrollment Brazil | 12 Participants | 13 Participants | 25 Participants |
| Sex: Female, Male Female | 10 Participants | 11 Participants | 21 Participants |
| Sex: Female, Male Male | 2 Participants | 2 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 14 | 0 / 14 |
| other Total, other adverse events | 0 / 14 | 0 / 14 |
| serious Total, serious adverse events | 0 / 14 | 0 / 14 |
Outcome results
Primary
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).
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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Grupo TENS | Painful Symptoms | T2 | 3.17 score on a scale | Standard Deviation 2.48 |
| Grupo TENS | Painful Symptoms | T0 | 7.58 score on a scale | Standard Deviation 2.64 |
| Grupo TENS | Painful Symptoms | T3 | 5.75 score on a scale | Standard Deviation 2.49 |
| Grupo TENS | Painful Symptoms | T1 | 5.08 score on a scale | Standard Deviation 2.94 |
| Grupo LLLT | Painful Symptoms | T3 | 3.75 score on a scale | Standard Deviation 3.08 |
| Grupo LLLT | Painful Symptoms | T2 | 4.50 score on a scale | Standard Deviation 2.88 |
| Grupo LLLT | Painful Symptoms | T1 | 5.33 score on a scale | Standard Deviation 3.23 |
| Grupo LLLT | Painful Symptoms | T0 | 6.92 score on a scale | Standard Deviation 2.54 |
Secondary
Salivary Flow
The unstimulated salivary flow rate will be determined by the ratio volume of saliva collected, expressed in millimeters per minute (ml/min).
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Grupo TENS | Salivary Flow | T1 | 0.22 average of ml collected per minute | Standard Deviation 0.08 |
| Grupo TENS | Salivary Flow | T3 | 0.30 average of ml collected per minute | Standard Deviation 0.36 |
| Grupo TENS | Salivary Flow | T2 | 0.36 average of ml collected per minute | Standard Deviation 0.22 |
| Grupo TENS | Salivary Flow | T0 | 0.32 average of ml collected per minute | Standard Deviation 0.23 |
| Grupo LLLT | Salivary Flow | T1 | 0.30 average of ml collected per minute | Standard Deviation 0.3 |
| Grupo LLLT | Salivary Flow | T0 | 0.27 average of ml collected per minute | Standard Deviation 0.2 |
| Grupo LLLT | Salivary Flow | T2 | 0.22 average of ml collected per minute | Standard Deviation 0.13 |
| Grupo LLLT | Salivary Flow | T3 | 0.24 average of ml collected per minute | Standard Deviation 0.14 |