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Study Evaluating the Laser Diode Effect Burning Mouth Syndrome

Study Evaluating the Laser Diode Effect on Burning Mouth Syndrome

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02757612
Acronym
laser
Enrollment
30
Registered
2016-05-02
Start date
2015-06-30
Completion date
2016-07-30
Last updated
2017-05-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Burning Mouth Syndrome

Keywords

laser diode, pain

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

Interventions

RADIATIONlaser diode

laser diode

Sponsors

Universidad de Murcia
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

* 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

Design outcomes

Primary

MeasureTime frameDescription
Pain4 weeksVAS (Visual Analog Scale).

Secondary

MeasureTime frameDescription
xerostomia4 weeksXerostomia severity test (Xerostomia Inventory):
oral quality of life4 weeksOral Health Impact Profile (OHIP-14)
anxiety and depression4 weeksLevels of anxiety and depression were assessed by Hospital Anxiety and Depression Scale (HADS

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026