The present study was designed to evaluation of the effectiveness of low level laser to improve symptoms of burning mouth syndrome. Sixty patients from Zahedan Dental School is selected. inclusion criteria: is patient's with burning mouth syndrome and
exclusive criteria is patient's with known systemic disease, patient's under 18 years, pregnancy, patient's with oral denture.
In each patient, 10 points in the mouth with a laser wavelength of 630 nm and a power of 30 mW for 10 seconds twice a week for 4 weeks will be illuminated.After finishing treatment, patients will be evaluated in severity of burning.
General information
Acronym
The effect of laser on burning mouth and quality of life
IRCT registration information
IRCT registration number:IRCT201312173133N7
Registration date:2014-01-31, 1392/11/11
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-01-31, 1392/11/11
Registrant information
Name
Fateme Arbabi Kalati
Name of organization / entity
Dental school of Zahedan
Country
Iran (Islamic Republic of)
Phone
+98 54 1244 1814
Email address
farbabi@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Zahedan University of Medical Siences
Expected recruitment start date
2014-01-21, 1392/11/01
Expected recruitment end date
2014-05-22, 1393/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of low level laser in improvement of symptoms and quality of life of burning mouth syndrome
Public title
Evaluation of the effect of low level laser in improvement of symptoms and quality of life of burning mouth syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria:
patient's with burning mouth syndrome.
exclusive criteria:
patient's with known systemic disease, patient's under 18 years, pregnancy, patient's with oral denture.
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Zahedan University of Medical Sciences
Street address
Zahedan University of Medical Sciences, Hesabi Squer, Zahedan,Iran
City
Zahedan
Postal code
9816743463
Approval date
2013-11-03, 1392/08/12
Ethics committee reference number
6079
Health conditions studied
1
Description of health condition studied
burning muth syndrome
ICD-10 code
F59
ICD-10 code description
Unspecified behavioural syndromes associated with physiological disturbances and physical factors
Primary outcomes
1
Description
decrease of burning muth
Timepoint
4 weeks
Method of measurement
VSA scale
Secondary outcomes
1
Description
well being of xerostomia
Timepoint
one month
Method of measurement
lent soma
Intervention groups
1
Description
expose of low level laser 630 nanometer in 10 points of oral mucosa for ten seconds
Category
Placebo
2
Description
expoture to off laser in same time and points
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Zahedan Faculty of Dentistery
Full name of responsible person
Street address
City
Zahedan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Dr Hamidreza Sagheb
Street address
Oral medicine departeman,Faculty of dentistery, Azadegan aven, Zahedan, Iran
City
Zahedan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zahedan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Dr. Hamidreza Mahmudzadeh Sagheb
Position
investigation assistant
Other areas of specialty/work
Street address
Zahedan University of Medical Sciences, Hesabi Squer, Zahedan,Iran
City
Zahedan
Postal code
Phone
+98 54 1342 5744
Fax
Email
histology_iri@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Dr. Fateme Arbabi Kalati
Position
lecturer
Other areas of specialty/work
Street address
Zahedan, eastern Azadagan street, dentistry college
City
Zahedan
Postal code
9817699693
Phone
+98 54 1244 1824
Fax
Email
F kalati@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Fateme Arbabi-Kalti
Position
associated professor
Other areas of specialty/work
Street address
Faculty of dentistery
City
Zahedan
Postal code
Phone
+98 915 543 3348
Fax
+98 54 1241 4003
Email
farbabi@razi.tuma.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)