Comparison Between Two Treatments for Burning Mouth

NCT ID: NCT05816200

Last Updated: 2024-06-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-01
• Study Completion Date: 2022-06-30

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.

Conditions

Burning Mouth Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Grupo TENS

Participants with burning mouth underwent to transcutaneous electrical nerve stimulation

Group Type: EXPERIMENTAL

Transcutaneous Electric Nerve Stimulation

Intervention Type: DEVICE

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.

Grupo LLLT

Participants with burning mouth underwent low-level laser therapy

Group Type: ACTIVE_COMPARATOR

Low-Level Light Therapy

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

Other Intervention Names

Low Power Laser Therapy

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 77 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Universidade Federal do Rio Grande do Norte

OTHER

Sponsor Role: lead

Responsible Party

Cristianne Kalinne Santos Medeiros

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Patrícia Oliveira, PhD

Role: STUDY_DIRECTOR

Universidade Federal do Rio Grande do Norte

Locations

Department of Dentistry, Federal University of Rio Grande do Norte

Natal, Rio Grande do Norte, Brazil

Countries

Brazil

References

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.

Reference Type: RESULT

PMID: 26873501 (View on PubMed)

Medeiros CKS, Serrao MDCPN, de Lima AAS, da Silveira EJD, de Oliveira PT. Comparative analysis of photobiomodulation therapy and transcutaneous electrical nerve stimulation for burning mouth: a randomized clinical trial. Clin Oral Investig. 2023 Oct;27(10):6157-6165. doi: 10.1007/s00784-023-05232-7. Epub 2023 Sep 1.

Reference Type: DERIVED

PMID: 37656286 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

RBR-7fvcjkz

Identifier Type: REGISTRY

Identifier Source: secondary_id

U1111-1274-3207

Identifier Type: -

Identifier Source: org_study_id