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Completed

NCT Number: NCT02757612

Study Evaluating the Laser Diode Effect Burning Mouth Syndrome

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

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Key information

Conditions

Burning Mouth Syndrome Mouth Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pia Lopez Jornet

Murcia, 30008, Spain

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

laser diode

Radiation

laser diode

Primary outcomes

  1. Pain

    Time frame: 4 weeks

    VAS (Visual Analog Scale).

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Universidad de Murcia

Other

Registry information

Official study title

Study Evaluating the Laser Diode Effect on Burning Mouth Syndrome

Acronym: laser

Important dates

Study start
2015
Primary completion
2015
Study completion
2016
First posted
May 2, 2016
Registry last updated
May 4, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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