Clinical trial NCT02757612: Study Evaluating the Laser Diode Effect Burning Mouth Syndrome
Official title: Study Evaluating the Laser Diode Effect on Burning Mouth Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Burning Mouth Syndrome
Keywords: laser diode, pain
Lead sponsor: Universidad de Murcia
Sponsor class: OTHER
First posted: 2016-05-02
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Pain
timeFrame: 4 weeks
Secondary outcomes:
measure: xerostomia
timeFrame: 4 weeks
measure: oral quality of life
timeFrame: 4 weeks
measure: anxiety and depression
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Murcia
country: Spain
facility: Pia Lopez Jornet
Study officials:
affiliation: University Murcia
name: Lopez-Jornet Pia, MD DDS PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.
citation: Spanemberg JC, Lopez Lopez 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.
citation: Pezelj-Ribaric S, Kqiku L, Brumini G, Urek MM, Antonic R, Kuis D, Glazar I, Stadtler 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.