NCT02757612

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2015

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

April 27, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 2, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2016

Completed
Last Updated

May 4, 2017

Status Verified

May 1, 2017

Enrollment Period

4 months

First QC Date

April 27, 2016

Last Update Submit

May 1, 2017

Conditions

Burning Mouth Syndrome

Keywords

laser diode, pain

Outcome Measures

Primary Outcomes (1)

  • Pain

    VAS (Visual Analog Scale).

    4 weeks

Secondary Outcomes (3)

  • xerostomia

    4 weeks

  • oral quality of life

    4 weeks

  • anxiety and depression

    4 weeks

Study Arms (2)

Interventional

ACTIVE COMPARATOR

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

Comparator

SHAM 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

laser diodeRADIATION

laser diode

ComparatorInterventional

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pia Lopez Jornet

Murcia, 30008, Spain

Location

Related Publications (4)

  • 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.

    PMID: 21054200BACKGROUND

  • 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.

    PMID: 26873501BACKGROUND

  • 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.

    PMID: 26359814BACKGROUND

  • 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.

    PMID: 22773117BACKGROUND

MeSH Terms

Conditions

Burning Mouth SyndromePain

Interventions

Lasers, Semiconductor

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

LasersOptical DevicesEquipment and SuppliesRadiation Equipment and Supplies

Study Officials

  • Lopez-Jornet Pia, MD DDS PhD

    University Murcia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD,DDS,PhD

Study Record Dates

First Submitted

April 27, 2016

First Posted

May 2, 2016

Study Start

June 1, 2015

Primary Completion

October 1, 2015

Study Completion

July 30, 2016

Last Updated

May 4, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)