Comparison Between Two Treatments for Burning Mouth

NCT05816200 | Completed Results DMC FDA Device

• 2 other identifiers: U1111-1274-3207RBR-7fvcjkz
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Burning Mouth Syndrome

Keywords

Low-Level Light Therapy; Transcutaneous Electric Nerve Stimulation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (2)

Grupo TENS

EXPERIMENTAL

Participants with burning mouth underwent to transcutaneous electrical nerve stimulation

Device: Transcutaneous Electric Nerve Stimulation

Grupo LLLT

ACTIVE COMPARATOR

Participants with burning mouth underwent low-level laser therapy

Device: Low-Level Light Therapy

Interventions

Low-Level Light Therapy 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.

Also known as: Low Power Laser Therapy

Grupo LLLT

Transcutaneous Electric Nerve Stimulation 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 TENS

Eligibility Criteria

• Age: 18 Years - 77 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patients who did not comply with the study treatment protocol.

Sponsors & Collaborators

• Universidade Federal do Rio Grande do Norte: lead

Study Sites (1)

Department of Dentistry, Federal University of Rio Grande do Norte

Natal, Rio Grande do Norte, 59056-000, Brazil

Location

Related Publications (2)

• 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.

  PMID: 26873501 RESULT

• 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.

  PMID: 37656286 DERIVED

MeSH Terms

Conditions

Burning Mouth Syndrome

Interventions

Low-Level Light Therapy; Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy; Electric Stimulation Therapy; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Results Point of Contact

• Title: PhD Cristianne Kalinne Santos Medeiros
• Organization: Federal University of Rio Grande do Norte

cristiannekalinne@gmail.com

+55(84)3342-2341

Study Officials

• Patrícia Oliveira, PhD

  Universidade Federal do Rio Grande do Norte

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 3, 2023
• First Posted: April 18, 2023
• Study Start: April 1, 2021
• Primary Completion: December 3, 2021
• Study Completion: June 30, 2022
• Last Updated: June 21, 2024
• Results First Posted: June 21, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)