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Comparison between two treatments for Burning Mouth

Comparative analysis of Burning Mouth Syndrome Treatment using Low Power Laser (LTTP) and Transcutaneous Electrical Nerve Stimulation System: a randomized clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-7fvcjkz
Enrollment
Unknown
Registered
2022-03-30
Start date
2021-04-01
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Burning Mouth Syndrome

Interventions

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
E02.594.540
E02.331.800

Sponsors

Departamento de Odontologia - Universidade Federal do Rio grande do Norte
Lead Sponsor
Departamento de Odontologia - Universidade Federal do Rio grande do Norte
Collaborator

Eligibility

Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Individuals of both sexes, over 18 years of age; subjects who had recurrent intraoral or dysesthetic burning sensation daily for more than 2 hours a day for more than 3 months without clinically evident causal lesions; individuals who presented a sensation of pain, burning or burning in the oral mucosa and who presented some local or systemic factor that justified such symptoms; individuals who were physically and emotionally able to participate in the study tests

Exclusion criteria

Exclusion criteria: Subjects who did not complete the study treatment protocol; individuals who presented clinical alterations in the oral mucosa

Design outcomes

Secondary

MeasureTime frame
Expected outcome 2: an increase in the salivary flow rate is expected, using for this purpose the collection of unstimulated salivary flow before the start of treatment (T0), after one month of treatment, after two months of treatment (T2 ) and 30 days after the end of treatment (T3) for statistical analysis purposes. Patients with unstimulated salivary flow < 0.1 ml/min were diagnosed with hyposalivation.;Outcome found 2: no intragroup statistical difference was observed in relation to unstimulated salivary flow, but it was possible to demonstrate an intergroup statistical difference between the time intervals T1 and T2 (p=0.052), in which an increase in the average salivary flow was observed in the TENS group and a decrease in the LLLT group.

Primary

MeasureTime frame
Expected outcome 1: it is expected to find a decrease in the score of burning mouth symptoms, determined using the Visual Analogue Scale (VAS), which will be used to collect data before the start of treatment (T0), after one month of treatment (T1), after two months of treatment (T2) and 30 days after the end of treatment (T3) for statistical analysis purposes. ;Finding outcome 1: a statistically significant difference was observed in relation to burning mouth symptoms in the TENS group between the times T0xT1, T0xT2 and T0xT3, and in the LLLT group, between T0xT2 and T0xT3 (p<0.001). A significant intergroup difference (p=0.034) was also observed between the T2 and T3 time intervals, with mean VAS scores decreasing in the LLLT group and increasing in the TENS group (p=0.003).

Countries

Brazil

Contacts

Public ContactCristianne Kalinne Medeiros

Universidade Federal do Rio Grande do Norte

cristiannekalinne@gmail.com+55(84)3215-4100

Outcome results

None listed

Source: REBEC (via WHO ICTRP)