Comparison Between Two Treatments for Burning Mouth

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.

Study Overview

• Status: Completed
• Conditions: Burning Mouth Syndrome
• Intervention / Treatment: Device: Transcutaneous Electric Nerve Stimulation; Device: Low-Level Light Therapy

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.

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Grupo TENS; Participants with burning mouth underwent to transcutaneous electrical nerve stimulation	Device: 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.
Active Comparator: Grupo LLLT; Participants with burning mouth underwent low-level laser therapy	Device: 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.; Other Names: Low Power Laser Therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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).

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Universidade Federal do Rio Grande do Norte
• Investigators: Study Director: Patrícia Oliveira, PhD, Universidade Federal do Rio Grande do Norte

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2021
• Primary Completion (Actual): December 3, 2021
• Study Completion (Actual): June 30, 2022

Study Registration Dates

• First Submitted: April 3, 2023
• First Submitted That Met QC Criteria: April 3, 2023
• First Posted (Actual): April 18, 2023

Study Record Updates

• Last Update Posted (Actual): June 21, 2024
• Last Update Submitted That Met QC Criteria: June 17, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: Transcutaneous Electric Nerve Stimulation; Low-Level Light Therapy
• Additional Relevant MeSH Terms: Wounds and Injuries; Stomatognathic Diseases; Mouth Diseases; Burns; Burning Mouth Syndrome
• Other Study ID Numbers: U1111-1274-3207; RBR-7fvcjkz (Registry Identifier: Brazilian Registration of Clinical Trials (ReBEC))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The article referring to this clinical trial is being edited for subsequent publication in a journal.

Drug and device information, study documents

• 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