Comparative Analysis of Low-Level Light Therapy and Transcutaneous Electrical Nerve Stimulation for Burning Mouth: a Randomized Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 28
- Locations
- 1
- Primary Endpoint
- Painful Symptoms
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 77 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
Grupo TENS
Participants with burning mouth underwent to transcutaneous electrical nerve stimulation
Intervention: Transcutaneous Electric Nerve Stimulation (Device)
Grupo LLLT
Participants with burning mouth underwent low-level laser therapy
Intervention: Low-Level Light Therapy (Device)
Outcomes
Primary Outcomes
Painful Symptoms
Time Frame: 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).
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 Outcomes
- Salivary Flow(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)
Investigators
Cristianne Kalinne Santos Medeiros
Principal Investigator
Universidade Federal do Rio Grande do Norte