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Trial record 4 of 19 for:    "Burning Mouth Syndrome"

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

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ClinicalTrials.gov Identifier: NCT02757612
Recruitment Status : Completed
First Posted : May 2, 2016
Last Update Posted : May 4, 2017
Sponsor:
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

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



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

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 ClinicalTrials.gov identifier (NCT number): NCT02757612


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

Publications:
Responsible Party: Pia Lopez Jornet, MD,DDS,PhD, Universidad de Murcia
ClinicalTrials.gov Identifier: NCT02757612     History of Changes
Other Study ID Numbers: UNIVERSIDAD DE MURCIA
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:
Syndrome
Burns
Burning Mouth Syndrome
Disease
Pathologic Processes
Wounds and Injuries
Mouth Diseases
Stomatognathic Diseases