Study Evaluating the Laser Diode Effect Burning Mouth Syndrome

Burning Mouth Syndrome Clinical Trial

— laser  

Official title:

Study Evaluating the Laser Diode Effect on Burning Mouth Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02757612
• Other study ID #: UNIVERSIDAD DE MURCIA
• Status: Completed
• Phase: N/A
• First received: April 27, 2016
• Last updated: May 1, 2017
• Start date: June 2015
• Est. completion date: July 30, 2016

Study information

• Verified date: May 2017
• Source: Universidad de Murcia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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 information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: July 30, 2016
• Est. primary completion date: October 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Burning Mouth Syndrome
• Burns
• Syndrome

Intervention

Radiation:
• laser diode
laser diode

Locations

Country	Name	City	State
Spain	Pia Lopez Jornet	Murcia

Sponsors (1)

Lead Sponsor	Collaborator
Universidad de Murcia

Country where clinical trial is conducted

Spain, 

References & Publications (4)

Arduino PG, Cafaro A, Garrone M, Gambino A, Cabras M, Romagnoli E, Broccoletti R. A randomized pilot study to assess the safety and the value of low-level laser therapy versus clonazepam in patients with burning mouth syndrome. Lasers Med Sci. 2016 May;31(4):811-6. doi: 10.1007/s10103-016-1897-8. Epub 2016 Feb 12. — View Citation

Loncar B, Stipetic MM, Baricevic M, Risovic D. The effect of low-level laser therapy on salivary glands in patients with xerostomia. Photomed Laser Surg. 2011 Mar;29(3):171-5. doi: 10.1089/pho.2010.2792. Epub 2010 Nov 6. — View Citation

Pezelj-Ribaric S, Kqiku L, Brumini G, Urek MM, Antonic R, Kuiš D, Glažar I, Städtler P. Proinflammatory cytokine levels in saliva in patients with burning mouth syndrome before and after treatment with low-level laser therapy. Lasers Med Sci. 2013 Jan;28(1):297-301. doi: 10.1007/s10103-012-1149-5. Epub 2012 Jul 8. — View Citation

Spanemberg JC, López López J, de Figueiredo MA, Cherubini K, Salum FG. Efficacy of low-level laser therapy for the treatment of burning mouth syndrome: a randomized, controlled trial. J Biomed Opt. 2015 Sep;20(9):098001. doi: 10.1117/1.JBO.20.9.098001. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain	VAS (Visual Analog Scale).	4 weeks
Secondary	xerostomia	Xerostomia severity test (Xerostomia Inventory):	4 weeks
Secondary	oral quality of life	Oral Health Impact Profile (OHIP-14)	4 weeks
Secondary	anxiety and depression	Levels of anxiety and depression were assessed by Hospital Anxiety and Depression Scale (HADS	4 weeks