MedPath

Study Evaluating the Laser Diode Effect Burning Mouth Syndrome

Not Applicable
Completed
Conditions
Burning Mouth Syndrome
Registration Number
NCT02757612
Lead Sponsor
Universidad de Murcia
Brief Summary

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

Detailed 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

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
30
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Pain4 weeks

VAS (Visual Analog Scale).

Secondary Outcome Measures
NameTimeMethod
xerostomia4 weeks

Xerostomia severity test (Xerostomia Inventory):

oral quality of life4 weeks

Oral Health Impact Profile (OHIP-14)

anxiety and depression4 weeks

Levels of anxiety and depression were assessed by Hospital Anxiety and Depression Scale (HADS

Trial Locations

Locations (1)

Pia Lopez Jornet

🇪🇸

Murcia, Spain

Pia Lopez Jornet
🇪🇸Murcia, Spain

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.