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Study Evaluating the Laser Diode Effect Burning Mouth Syndrome (laser)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02757612
Recruitment Status : Completed
First Posted : May 2, 2016
Last Update Posted : May 4, 2017
Information provided by (Responsible Party):
Pia Lopez Jornet, 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

Condition or disease Intervention/treatment Phase
Burning Mouth Syndrome Radiation: laser diode Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Study Evaluating the Laser Diode Effect on Burning Mouth Syndrome
Study Start Date : June 2015
Actual Primary Completion Date : October 2015
Actual Study Completion Date : July 30, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Burns

Arm Intervention/treatment
Active Comparator: Interventional

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

Radiation: laser diode
laser diode

Sham Comparator: Comparator

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

Radiation: laser diode
laser diode

Primary Outcome Measures :
  1. Pain [ Time Frame: 4 weeks ]
    VAS (Visual Analog Scale).

Secondary Outcome Measures :
  1. xerostomia [ Time Frame: 4 weeks ]
    Xerostomia severity test (Xerostomia Inventory):

  2. oral quality of life [ Time Frame: 4 weeks ]
    Oral Health Impact Profile (OHIP-14)

  3. anxiety and depression [ Time Frame: 4 weeks ]
    Levels of anxiety and depression were assessed by Hospital Anxiety and Depression Scale (HADS

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02757612

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Pia Lopez Jornet
Murcia, Spain, 30008
Sponsors and Collaborators
Universidad de Murcia
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Principal Investigator: Lopez-Jornet Pia, MD DDS PhD University Murcia

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Responsible Party: Pia Lopez Jornet, MD,DDS,PhD, Universidad de Murcia Identifier: NCT02757612     History of Changes
First Posted: May 2, 2016    Key Record Dates
Last Update Posted: May 4, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Pia Lopez Jornet, Universidad de Murcia:
laser diode, pain
Additional relevant MeSH terms:
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Burning Mouth Syndrome
Pathologic Processes
Wounds and Injuries
Mouth Diseases
Stomatognathic Diseases