Study Evaluating the Laser Diode Effect Burning Mouth Syndrome

Not Applicable

Completed

• Conditions: Burning Mouth Syndrome
• Interventions: Radiation: laser diode

• 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

Study Timeline

• Study Start: 2015-06
• Primary Completion: 2015-10
• Study First Submitted: 2016-04-27
• Study First Submitted QC: 2016-04-28
• Study First Posted: 2016-05-02
• Study Completion: 2016-07-30
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-01
• Last Update Posted: 2017-05-04

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

Arm && Interventions

Group	Intervention	Description
Interventional	laser diode	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
Comparator	laser diode	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

Primary Outcome Measures

Name	Time	Method
Pain	4 weeks	VAS (Visual Analog Scale).

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Pia Lopez Jornet; 🇪🇸 Murcia, Spain