Back to resultsStudy Evaluating the Laser Diode Effect Burning Mouth Syndrome (laser)
Primary Purpose
Burning Mouth Syndrome
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
laser diode
Sponsored by
About this trial
This is an interventional treatment trial for Burning Mouth Syndrome focused on measuring laser diode, pain
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
Sites / Locations
- Pia Lopez Jornet
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
Interventional
Comparator
Arm Description
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
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
Outcomes
Primary Outcome Measures
Pain
VAS (Visual Analog Scale).
Secondary Outcome Measures
xerostomia
Xerostomia severity test (Xerostomia Inventory):
oral quality of life
Oral Health Impact Profile (OHIP-14)
anxiety and depression
Levels of anxiety and depression were assessed by Hospital Anxiety and Depression Scale (HADS
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02757612
Brief Title
Study Evaluating the Laser Diode Effect Burning Mouth Syndrome
Acronym
laser
Official Title
Study Evaluating the Laser Diode Effect on Burning Mouth Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
June 2015 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
July 30, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad de Murcia
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burning Mouth Syndrome
Keywords
laser diode, pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Interventional
Arm Type
Active Comparator
Arm Description
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
Arm Title
Comparator
Arm Type
Sham Comparator
Arm Description
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
Intervention Type
Radiation
Intervention Name(s)
laser diode
Intervention Description
laser diode
Primary Outcome Measure Information:
Title
Pain
Description
VAS (Visual Analog Scale).
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
xerostomia
Description
Xerostomia severity test (Xerostomia Inventory):
Time Frame
4 weeks
Title
oral quality of life
Description
Oral Health Impact Profile (OHIP-14)
Time Frame
4 weeks
Title
anxiety and depression
Description
Levels of anxiety and depression were assessed by Hospital Anxiety and Depression Scale (HADS
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lopez-Jornet Pia, MD DDS PhD
Organizational Affiliation
University Murcia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pia Lopez Jornet
City
Murcia
ZIP/Postal Code
30008
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
21054200
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.
Results Reference
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PubMed Identifier
26873501
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.
Results Reference
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PubMed Identifier
26359814
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.
Results Reference
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PubMed Identifier
22773117
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.
Results Reference
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Study Evaluating the Laser Diode Effect Burning Mouth Syndrome
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