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CompletedNCT02757612laserUpdated May 4, 2017

Study Evaluating the Laser Diode Effect Burning Mouth Syndrome

An interventional study of laser diode in Burning Mouth Syndrome, sponsored by Universidad de Murcia. Completed at 1 site in Spain. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-05-04.

Sponsored by Universidad de Murcia · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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

Read the 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

02

Conditions studied

  • Burning Mouth Syndrome

Keywords

  • laser diode, pain
03

In context

Burning Mouth Syndrome

44 studies on the registry are indexed under Burning Mouth Syndrome; 6 are open to participants now.

This study's enrollment of 30 is below the median of 42 across 35 interventional studies indexed under Burning Mouth Syndrome.

Browse Burning Mouth Syndrome studies →

Lead sponsor

Universidad de Murcia is the lead sponsor of 77 studies on the registry; 16 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
30 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • Radiationlaser diode

    laser diode

06

What researchers measure

Primary outcomes

  1. Pain

    VAS (Visual Analog Scale).

    Time frame: 4 weeks

Secondary outcomes

  1. xerostomia

    Xerostomia severity test (Xerostomia Inventory):

    Time frame: 4 weeks

  2. oral quality of life

    Oral Health Impact Profile (OHIP-14)

    Time frame: 4 weeks

  3. anxiety and depression

    Levels of anxiety and depression were assessed by Hospital Anxiety and Depression Scale (HADS

    Time frame: 4 weeks

07

Study locations

1 site
  • Pia Lopez Jornet
    Murcia, 30008, Spain
08

References and documents

Publications

  • 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. PubMed 21054200 ↗
  • 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. PubMed 26873501 ↗
  • 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. PubMed 26359814 ↗
  • 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. PubMed 22773117 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 4, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02757612
Lead sponsor
Universidad de Murcia
Responsible party
Pia Lopez Jornet (MD,DDS,PhD, Universidad de Murcia) — Principal investigator
First posted
May 2, 2016
Start date
Jun 2015
Primary completion
Oct 2015
Completion
Jul 30, 2016
Last update
May 4, 2017

Study contacts

Lopez-Jornet Pia, MD DDS PhD
principal investigator · University Murcia

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2017. You cannot join it, but the record below documents what was studied.

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