Burning Mouth Syndrome Clinical Trial
Official title:
COMPARATIVE ANALYSIS OF THE TREATMENT OF BURNING MOUTH WITH LOW-INTENSITY LASER THERAPY AND TRANSCUTANEOUS ELECTRICAL NERVOUS STIMULATION: RANDOMIZED CLINICAL TRIAL
Verified date | April 2023 |
Source | Universidade Federal do Rio Grande do Norte |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 25 |
Est. completion date | June 30, 2022 |
Est. primary completion date | December 3, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 41 Years to 77 Years |
Eligibility | Inclusion Criteria: patients over 18 years of age who had a 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, but who did not present clinical alterations in the oral mucosa such as erosive lichen planus, geographic tongue, infections, allergic reactions, trauma and injuries by physical or chemical agents. - Exclusion Criteria: patients who did not comply with the study treatment protocol. |
Country | Name | City | State |
---|---|---|---|
Brazil | Department of Dentistry, Federal University of Rio Grande do Norte | Natal | Rio Grande Do Norte |
Lead Sponsor | Collaborator |
---|---|
Universidade Federal do Rio Grande do Norte |
Brazil,
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 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Symptoms | Improvement of symptoms, determined by Visual Analogue Scale (VAS) (0-10 cm) before the beginning of treatment, with one month of treatment, with two months of treatment and 30 days after the end of treatment. | Three months | |
Secondary | Salivary flow | Increase in salivary flow, determined by collecting unstimulated salivary flow before starting treatment, at one month of treatment, at two months of treatment and 30 days after the end of treatment. | Three months |
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