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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

Tracking Information
First Submitted Date  ICMJE April 27, 2016
First Posted Date  ICMJE May 2, 2016
Last Update Posted Date May 4, 2017
Study Start Date  ICMJE June 2015
Actual Primary Completion Date October 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 28, 2016)
Pain [ Time Frame: 4 weeks ]
VAS (Visual Analog Scale).
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02757612 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 28, 2016)
  • xerostomia [ Time Frame: 4 weeks ]
    Xerostomia severity test (Xerostomia Inventory):
  • oral quality of life [ Time Frame: 4 weeks ]
    Oral Health Impact Profile (OHIP-14)
  • anxiety and depression [ Time Frame: 4 weeks ]
    Levels of anxiety and depression were assessed by Hospital Anxiety and Depression Scale (HADS
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study Evaluating the Laser Diode Effect Burning Mouth Syndrome
Official Title  ICMJE Study Evaluating the Laser Diode Effect on Burning Mouth Syndrome
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Burning Mouth Syndrome
Intervention  ICMJE Radiation: laser diode
laser diode
Study Arms  ICMJE
  • 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

    Intervention: Radiation: 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

    Intervention: Radiation: laser diode
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 28, 2016)
30
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 30, 2016
Actual Primary Completion Date October 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02757612
Other Study ID Numbers  ICMJE UNIVERSIDAD DE MURCIA
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Pia Lopez Jornet, Universidad de Murcia
Study Sponsor  ICMJE Universidad de Murcia
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Lopez-Jornet Pia, MD DDS PhD University Murcia
PRS Account Universidad de Murcia
Verification Date May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP