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Comparison of the use of Photobiomodulator Therapy and medication for the treatment of Burning Mouth: Clinical trial

Comparative Analysis of Photobiomodulatory and Pharmacological Therapy for Burning Mouth: A Randomized Clinical Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-7pxxjzd
Enrollment
80
Registered
2026-05-25
Start date
2024-06-01
Completion date
Unknown
Last updated
2026-06-01

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

Conditions

Burning Mouth Syndrome Stomatognathic Diseases

Interventions

This is an open-label, randomized, controlled clinical trial with four arms, in which 80 participants who meet the eligibility criteria will be allocated by simple randomization (draw) into 4 groups.
s recommendations, which consists of punctual applications with infrared laser (L2) (100mW power, 808 nm, 4 joules of energy/40 seconds) in the affected area, maintaining a one-centimeter distance bet

Sponsors

Universidade Federal do Rio Grande do Norte
Lead Sponsor
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; Individuals who presented with a burning sensation in the oral mucosa or recurrent dysesthesia, daily for more than two hours a day, for more than three months, without clinically evident causal lesions; Individuals who present with a burning sensation in the mouth or recurrent dysesthesia, even if they have salivary alterations or some systemic alteration that may be related to the symptoms; patients who are not undergoing any other type of treatment for burning mouth for at least three months at the time of inclusion in the study; Individuals who are physically able to attend the study tests

Exclusion criteria

Exclusion criteria: Individuals with Sjögren's syndrome who presented with alterations and/or lesions in the oral mucosa, such as erosive lichen planus, ulcerations, geographic tongue, infections, allergic reactions, trauma, and lesions caused by physical or chemical agents; individuals with a known allergy to pepper and its derivatives; pregnant or breastfeeding women; patients with severe neurological or psychiatric diseases that could interfere with pain perception or adherence to the protocol

Design outcomes

Primary

MeasureTime frame
Expected outcome 1: Topical capsaicin 0,001% used alone is expected to be more effective than low-level laser therapy in reducing painful symptoms in patients suffering from burning mouth syndrome, which will be assessed using the visual analog pain scale before, during, and after treatment. ;Outcome found 1: Topical capsaicin 0,001% used alone proved to be as effective as low-level laser therapy. And, when combined, the reduction in symptoms is already significant from the second week of treatment.

Secondary

MeasureTime frame
No secondary outcomes are expected.

Countries

BR

Contacts

Public ContactBrenda Ferreira

Universidade Federal do Rio Grande do Norte

brenda.carlos.098@ufrn.edu.br+55 84 3342-2341

Outcome results

None listed

Source: REBEC (via WHO ICTRP) · Data processed: Jun 11, 2026