- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05816200
Comparison Between Two Treatments for Burning Mouth
COMPARATIVE ANALYSIS OF THE TREATMENT OF BURNING MOUTH WITH LOW-INTENSITY LASER THERAPY AND TRANSCUTANEOUS ELECTRICAL NERVOUS STIMULATION: RANDOMIZED CLINICAL TRIAL
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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Rio Grande Do Norte
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Natal, Rio Grande Do Norte, Brazil, 59056-000
- Department of Dentistry, Federal University of Rio Grande do Norte
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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.
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Exclusion Criteria: patients who did not comply with the study treatment protocol.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Grupo TENS
Participants with burning mouth underwent 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.
|
Active Comparator: Grupo LLLT
Participants with burning mouth underwent low-level laser 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.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Symptoms
Time Frame: Three months
|
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.
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Three months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Salivary flow
Time Frame: Three months
|
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
|
Collaborators and Investigators
Investigators
- Study Director: Patrícia Oliveira, PhD, Universidade Federal do Rio Grande do Norte
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- U1111-1274-3207
- RBR-7fvcjkz (Registry Identifier: BRAZILIAN REGISTRATION OF CLINICAL TRIALS (ReBEC))
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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