Study Evaluating the Laser Diode Effect Burning Mouth Syndrome (laser)

Universidad de Murcia

Status: Completed

Conditions: Burning Mouth Syndrome

Treatments: Radiation: laser diode

Study type: Interventional

Funder types: Other

Identifiers

NCT02757612

UNIVERSIDAD DE MURCIA

Details and patient eligibility

About

The aim of this study was to report the effect of laser diode on the treatment of burning mouth syndrome (BMS)

Patients were randomly allocated to two different groups:

the first one (group A) underwent Laser diode whereas the second one (group B) received Laser diode inactive

Full description

The inclusion criteria were as follows: (a) oral burning sensation, at least in the last 6 months; (b) no detection of oral mucosal lesions; and (c) ability to complete the present clinical trial. The exclusion criteria were as follows: (a) diagnosis of Sjögren syndrome on the basis of European criteria ; (b) previous head and neck radiotherapy; (c) diagnosed lymphoma; (d) hepatitis C infection; (c) pregnant or breast-feeding women

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• diagnosis of burning mouth syndrome in accordance the International Classification of Headaches: continuous symptoms of oral burning or pain on a daily or almost daily basis, during all or part of the day for more than 6 months

Exclusion criteria

• history of head and neck malignancy, radiation therapy to the head and neck area, poorly managed diabetes mellitus, chronic thyroid disease, or known Sjogren's disease and pregnant

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 2 patient groups

Interventional

Active Comparator group

Description:

Device Laser diode parameters: spot size of 0.04 mm2, average power (output) of 40 mW and 0.4 J per irradiation point, energy density of 10 J cm2, irradiation time of 10 seconds per point 1 session per week during 4 session

Treatment:

Radiation: laser diode

Comparator

Sham Comparator group

Description:

laser probe inactive for similar duration as for the laser diode group; only a beep sound was produced by the laser machine 1 session per week during 4 session

Treatment:

Radiation: laser diode