Study Evaluating the Laser Diode Effect Burning Mouth Syndrome

Study Overview
=================
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

Official Title
-----------------
Study Evaluating the Laser Diode Effect on Burning Mouth Syndrome

Conditions
-----------------
Burning Mouth Syndrome

Intervention / Treatment
-----------------
* Radiation: laser diode


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Interventional<br>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 | Radiation: laser diode<br>* laser diode<br>|
| Sham Comparator: Comparator<br>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 | Radiation: laser diode<br>* laser diode<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain | VAS (Visual Analog Scale). | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| xerostomia | Xerostomia severity test (Xerostomia Inventory): | 4 weeks | 
| oral quality of life | Oral Health Impact Profile (OHIP-14) | 4 weeks | 
| anxiety and depression | Levels of anxiety and depression were assessed by Hospital Anxiety and Depression Scale (HADS | 4 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
laser diode, pain