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Comparison Between Two Treatments for Burning Mouth

Not Applicable
Completed
Conditions
Burning Mouth Syndrome
Interventions
Device: Transcutaneous Electric Nerve Stimulation
Device: Low-Level Light Therapy
Registration Number
NCT05816200
Lead Sponsor
Universidade Federal do Rio Grande do Norte
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
28
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 & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Grupo TENSTranscutaneous Electric Nerve StimulationParticipants with burning mouth underwent to transcutaneous electrical nerve stimulation
Grupo LLLTLow-Level Light TherapyParticipants with burning mouth underwent low-level laser therapy
Primary Outcome Measures
NameTimeMethod
Painful SymptomsBaseline (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 Outcome Measures
NameTimeMethod
Salivary FlowBaseline (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).

Trial Locations

Locations (1)

Department of Dentistry, Federal University of Rio Grande do Norte

🇧🇷

Natal, Rio Grande Do Norte, Brazil

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