Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| RBR-7fvcjkz | Registry Identifier | Brazilian Registration of Clinical Trials (ReBEC) |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Grupo TENS | Experimental | Participants with burning mouth underwent to transcutaneous electrical nerve stimulation |
|
| Grupo LLLT | Active Comparator | Participants with burning mouth underwent low-level laser therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low-Level Light Therapy | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Salivary Flow | The unstimulated salivary flow rate will be determined by the ratio volume of saliva collected, expressed in millimeters per minute (ml/min). | 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
• Patients who did not comply with the study treatment protocol.
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Patrícia Oliveira, PhD | Universidade Federal do Rio Grande do Norte | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Dentistry, Federal University of Rio Grande do Norte | Natal | Rio Grande do Norte | 59056-000 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26873501 | Result | 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. | |
| 37656286 | Derived |
Not provided
Not provided
The article referring to this clinical trial is being edited for subsequent publication in a journal.
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Grupo LLLT | Participants with burning mouth underwent low-level laser therapy. One participant was excluded from this group for not completing the treatment protocol of the present study 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | The age of the participants was measured in years, from which the average age of the participants in each group was calculated. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | Posted | Mean | Standard Deviation | score on a scale | 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). |
|
3 months
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| PhD Cristianne Kalinne Santos Medeiros | Federal University of Rio Grande do Norte | +55(84)3342-2341 | cristiannekalinne@gmail.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 13, 2024 | May 15, 2024 | Prot_SAP_001.pdf |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D002054 | Burning Mouth Syndrome |
| ID | Term |
|---|---|
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D028022 | Low-Level Light Therapy |
| D004561 | Transcutaneous Electric Nerve Stimulation |
| ID | Term |
|---|---|
| D053685 | Laser Therapy |
| D013812 | Therapeutics |
| D010789 | Phototherapy |
| D004599 | Electric Stimulation Therapy |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| Transcutaneous Electric Nerve Stimulation | Device | 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. |
|
| 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. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Count of Participants |
| Participants |
| No |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Race was measured based on the Brazilian Institute of Geography and Statistics (IBGE) classification for the ethnic or racial denomination of people in Brazil. This classification includes the terms: black, brown, yellow, indigenous or white. | Count of Participants | Participants |
|
| Region of Enrollment | This randomized clinical trial involved patients with burning mouth seen at the Stomatology Service of the Department of Dentistry, Federal University of Rio Grande do Norte (UFRN), Natal, RN, Brazil. | Patients older than 18 years who had a burning or dysesthetic sensation in the oral mucosa that recurred daily for more than 2 h per day for more than 3 months, in the absence of clinically evident causal lesions, were included in the study. We also included patients with hyposalivation or any systemic alteration that could be related to a burning sensation in the oral mucosa. | Count of Participants | Participants |
|
| Painful symptoms | Pain/burning was the primary outcome and was measured on a visual analogue scale (VAS; 0-10 cm). Patients were asked to choose a number from 0 to 10 on the scale to describe the level of intensity of their symptoms, with higher values representing a worse outcome. | Mean | Standard Deviation | units on a scale |
|
| OG001 | Grupo LLLT | Participants with burning mouth underwent low-level laser therapy. One participant was excluded from this group for not completing the treatment protocol of the present study 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. |
|
|
| 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). | Posted | Mean | Standard Deviation | average of ml collected per minute | 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 |
|
|
|
| 0 |
| 14 |
| 0 |
| 14 |
| 0 |
| 14 |
| EG001 | 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. | 0 | 14 | 0 | 14 | 0 | 14 |
Not provided
Not provided
| D026741 |
| Physical Therapy Modalities |
| D012046 | Rehabilitation |
| D000698 | Analgesia |
| D000760 | Anesthesia and Analgesia |
| T2 |
|
| T3 |
|