Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000357257
Ethics application status
Approved
Date submitted
11/12/2008
Date registered
26/05/2009
Date last updated
5/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Infrared Laser Irradiation Applied to the Treatment of Burning Mouth Syndrome: a study with control group.
Scientific title
Infrared laser irradiation applied to the treatment of burning mouth syndrome patients.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Burning Mouth Syndrome 4121 0
Condition category
Condition code
Oral and Gastrointestinal 4316 4316 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The patients included in the trial will have their mucosal area affected by the burning sensation measured and calculated in square centimeters. This figure will be used to calculate the period of time of irradiation according to the following equation: energy (6J) X area affected (cm2) / power (0.12 Watts). Irradiation will be delivered in scanning mode twice a week, during two weeks.
Intervention code [1] 3830 0
Treatment: Other
Comparator / control treatment
The control group will be submitted to the same steps, without receiving active laser irradiation. The laser applying point will be placed in contact with the mucosa affected and the patient will hear the beep sound of the timer with no laser irradiation on.
Control group
Placebo

Outcomes
Primary outcome [1] 5206 0
To evaluate the effect of low level laser therapy on the treatment of burning mouth syndrome (BMS) patients through the use of visual analogue scales and a questionnaire on the global perceived effect of the therapy.
Timepoint [1] 5206 0
Evaluation of symptoms pre and post irradiation sessions, and 7,14,30,60 and 90 days after the last irradiation.
Secondary outcome [1] 9312 0
To investigate possible correlation between number of fungiform papillae on the tongue dorsum and the severity of symptoms. The tongue papillae will be visually counted through magnification of a photograph taken from the tongue dorsum with a plastic template of one square centimeter.
Timepoint [1] 9312 0
Prior to low laser irradiation sessions, 7 days and 90 days after the last irradiation.

Eligibility
Key inclusion criteria
Patients with burning mouth syndrome presenting symptoms at least for 6 months.
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with lesions on the oral mucosa that may be related to the burning sensation

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patients will be selected by two specialized researchers responsible for the correct diagnosis and for presenting the informed consent to the subjects. Randomization will be performed with the aid of a computer software by a researcher not involved with the clinical environment of the trial. Allocation concealment will be done with the use of sealed envelopes sequentially numbered which content will be known by the clinical researcher only at the time of group allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using a randomization table created by a computer software (www.graphpad.com)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
5/01/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment outside Australia
Country [1] 1469 0
Brazil
State/province [1] 1469 0
Sao Paulo
Country [2] 1470 0
Brazil
State/province [2] 1470 0

Funding & Sponsors
Funding source category [1] 4280 0
University
Name [1] 4280 0
University of Sao Paulo
Country [1] 4280 0
Brazil
Primary sponsor type
University
Name
University of Sao Paulo
Address
Av. Prof Lineu Prestes, 2227
Cidade Universitaria
Sao Paulo, SP, CEP 05508-000
Country
Brazil
Secondary sponsor category [1] 3853 0
None
Name [1] 3853 0
Address [1] 3853 0
Country [1] 3853 0
Other collaborator category [1] 506 0
Other Collaborative groups
Name [1] 506 0
Instituto de Pesquisas Energeticas e Nucleares - IPEN
Address [1] 506 0
Av. Lineu Prestes 2242 - Cidade Universitaria - CEP: 05508-000 - Sao Paulo - SP
Country [1] 506 0
Brazil

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 7117 0
Comite de Etica em Pesquisa da Faculdade de Odontologia da Universidade de Sao Paulo
Ethics committee address [1] 7117 0
Av. Prof Lineu Prestes, 2227
Cidade Universitaria
Sao Paulo, SP, CEP 05508-000
Ethics committee country [1] 7117 0
Brazil
Date submitted for ethics approval [1] 7117 0
11/09/2008
Approval date [1] 7117 0
17/02/2009
Ethics approval number [1] 7117 0
224649

Summary
Brief summary
The main purpose of this controlled clinical trial is to investigate the efficcacy of low level laser therapy in the treatment of Burning Mouth Syndrome patients, considering the mucosa affected and level of discomfort. Evaluation will be performed through visual analogue scales and a global perceived effect questionnaire after four laser irradiations sessions and a ninety days follow-up period.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35034 0
Address 35034 0
Country 35034 0
Phone 35034 0
Fax 35034 0
Email 35034 0
Contact person for public queries
Name 12381 0
Vivian Diane Pellegrini
Address 12381 0
Av. Prof Lineu Prestes, 2227
Cidade Universitaria
Sao Paulo, SP, CEP 05508-000
Country 12381 0
Brazil
Phone 12381 0
+55 11 30917883
Fax 12381 0
+55 11 30917883
Email 12381 0
vivian.pellegrini@usp.br
Contact person for scientific queries
Name 3309 0
Norberto Nobuo Sugaya
Address 3309 0
Av. Prof Lineu Prestes, 2227
Cidade Universitaria
Sao Paulo, SP, CEP 05508-000
Country 3309 0
Brazil
Phone 3309 0
+55 11 30917883
Fax 3309 0
+55 11 30917883
Email 3309 0
nnsugaya@usp.br

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
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Documents added automatically
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