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Comparison Between Two Treatments for Burning Mouth

U

Universidade Federal do Rio Grande do Norte

Status

Completed

Conditions

Burning Mouth Syndrome

Treatments

Device: Transcutaneous Electric Nerve Stimulation
Device: Low-Level Light Therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT05816200
RBR-7fvcjkz (Registry Identifier)
U1111-1274-3207

Details and patient eligibility

About

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.

Full 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.

Enrollment

28 patients

Sex

All

Ages

18 to 77 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

28 participants in 2 patient groups

Grupo TENS
Experimental group
Description:
Participants with burning mouth underwent to transcutaneous electrical nerve stimulation
Treatment:
Device: Transcutaneous Electric Nerve Stimulation
Grupo LLLT
Active Comparator group
Description:
Participants with burning mouth underwent low-level laser therapy
Treatment:
Device: Low-Level Light Therapy

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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