Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02757612
Other study ID # UNIVERSIDAD DE MURCIA
Secondary ID
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Completed NCT04475614 - Therapeutic Options for Treatment of Burning Mouth Syndrome N/A
Completed NCT00374673 - Efficacy of Transcranial Magnetic Stimulation (TMS) in Chronic Idiopathic Pain Disorders Phase 3
Completed NCT02964728 - Botulinum Toxin in Burning Mouth Syndrome Phase 2
Completed NCT04535973 - Hormonal Status and Quality of Life in Female Postmenopausal Patients With Burning Mouth Syndrome
Recruiting NCT06040190 - Effect of Treatments on Pain and Quality of Life in Individual With Burning Mouth Syndrome Phase 4
Not yet recruiting NCT05059418 - Burning Mouth Syndrome - New Diagnostic Criteria and Treatment N/A
Recruiting NCT01867151 - Effect of Gluten Free Diet in Patients With Burning Mouth Syndrome N/A
Completed NCT05872789 - Impact of Diazepam 1% Oral Gel Efficacy in Burning Mouth Syndrome N/A
Completed NCT05871580 - Effect to the Photobiomodulation in the Burning Mouth Syndrome N/A
Recruiting NCT05309070 - The Efficacy of N-acetyl-cysteine in the Treatment of Burning Mouth Syndrome N/A
Completed NCT05399238 - Thermography and Burning Mouth Syndrome
Completed NCT02580734 - Efficacy of Melatonin in Burning Mouth Syndrome (BMS) N/A
Completed NCT02382029 - Acupuncture Versus Clonazepam in Burning Mouth Syndrome Phase 0
Recruiting NCT05819697 - Reducing Patient Memory Recall in the Burning Mouth Patient Population
Completed NCT00862576 - A Study of the Association of Sleep Dysfunction and Burning Mouth Syndrome N/A
Not yet recruiting NCT04189367 - Treatment of Burning Mouth Syndrome With Integration of Traditional Chinese Medicine and Western Medicine Phase 3
Completed NCT00001524 - Thalidomide to Treat Oral Lesions in HIV-Infected Patients Phase 2
Recruiting NCT04481841 - Head Yuanshi Dian Therapy in Burning Mouth Syndrome Early Phase 1
Completed NCT02686359 - Opiorphin Levels in Fluids of Burning Mouth Syndrome Patients (OPIODYN) N/A
Completed NCT05309681 - Salivary Melatonin Levels and Sleep Quality in Patients With Burning Mouth Syndrome