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Comparison Between Two Treatments for Burning Mouth

Primary Purpose

Burning Mouth Syndrome

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Low-Level Light Therapy
Transcutaneous Electric Nerve Stimulation
Sponsored by
Universidade Federal do Rio Grande do Norte
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Burning Mouth Syndrome focused on measuring Low-Level Light Therapy, Transcutaneous Electric Nerve Stimulation

Eligibility Criteria

41 Years - 77 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Department of Dentistry, Federal University of Rio Grande do Norte

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Grupo TENS

Grupo LLLT

Arm Description

Participants with burning mouth underwent to transcutaneous electrical nerve stimulation

Participants with burning mouth underwent low-level laser therapy

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
April 3, 2023
Last Updated
April 3, 2023
Sponsor
Universidade Federal do Rio Grande do Norte
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1. Study Identification

Unique Protocol Identification Number
NCT05816200
Brief Title
Comparison Between Two Treatments for Burning Mouth
Official Title
COMPARATIVE ANALYSIS OF THE TREATMENT OF BURNING MOUTH WITH LOW-INTENSITY LASER THERAPY AND TRANSCUTANEOUS ELECTRICAL NERVOUS STIMULATION: RANDOMIZED CLINICAL TRIAL
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
April 1, 2021 (Actual)
Primary Completion Date
December 3, 2021 (Actual)
Study Completion Date
June 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Federal do Rio Grande do Norte

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burning Mouth Syndrome
Keywords
Low-Level Light Therapy, Transcutaneous Electric Nerve Stimulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Grupo TENS
Arm Type
Experimental
Arm Description
Participants with burning mouth underwent to transcutaneous electrical nerve stimulation
Arm Title
Grupo LLLT
Arm Type
Active Comparator
Arm Description
Participants with burning mouth underwent low-level laser therapy
Intervention Type
Device
Intervention Name(s)
Low-Level Light Therapy
Other Intervention Name(s)
Low Power Laser Therapy
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Transcutaneous Electric Nerve Stimulation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Symptoms
Description
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.
Time Frame
Three months
Secondary Outcome Measure Information:
Title
Salivary flow
Description
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.
Time Frame
Three months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
41 Years
Maximum Age & Unit of Time
77 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patrícia Oliveira, PhD
Organizational Affiliation
Universidade Federal do Rio Grande do Norte
Official's Role
Study Director
Facility Information:
Facility Name
Department of Dentistry, Federal University of Rio Grande do Norte
City
Natal
State/Province
Rio Grande Do Norte
ZIP/Postal Code
59056-000
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
The article referring to this clinical trial is being edited for subsequent publication in a journal.
Citations:
PubMed Identifier
26873501
Citation
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.
Results Reference
result

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Comparison Between Two Treatments for Burning Mouth

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