The aim of this study is to examine the effect of diode low power laser (980 nm) on xerostomia
Design
The present study is an interventional before-after clinical trial study with diode laser 980 nm on 28 patients with xerostomia.
Settings and conduct
The patients with xerostomia ,who had medical records (diabetes and hypertension) and had referred to the Health Houses of Anzali Health Network, were treated by 980nm diode laser.
Participants/Inclusion and exclusion criteria
People with xerostomia whose unstimulated saliva is less than 0.1 ml in 5 minutes will be included in the study.
People with a history of radiotherapy; patients suffering from Sjögren's syndrome or cancers; those who have been under treatment by xerogenic drugs or who don't have willingness to undergo treatment will be excluded.
Intervention groups
Parotid and Sub mandibular glands in patients with xerostomia, (6j , 300mW, 20 seconds) will be exposed to 980 nm diode laser extraorally and their sublingual glands will be intraorally exposed to 980 nm diode laser (4j, 200mW, 20 seconds) every other day for 10 sessions. Saliva of patients will be collected every session 5 minutes before and after laser therapy according to Navazesh technique
Main outcome variables
the volume of saliva;
the weight of saliva
General information
Reason for update
Acronym
LLLT
IRCT registration information
IRCT registration number:IRCT20170911036130N2
Registration date:2018-03-23, 1397/01/03
Registration timing:retrospective
Last update:2018-03-23, 1397/01/03
Update count:0
Registration date
2018-03-23, 1397/01/03
Registrant information
Name
Maryam Basirat
Name of organization / entity
Guilan university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 13 3348 6411
Email address
basirat@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
private
Expected recruitment start date
2017-10-15, 1396/07/23
Expected recruitment end date
2017-12-14, 1396/09/23
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of the Low power Diod Laser (980nm) on Xerostomia Treatment
Public title
The Effect of the Low Level Laser on Xerostomia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All male and female patients who are referred to Bandar Anzali health network and suffering from xerostomia based on the valid Fox questionnaire and their non-stimulated saliva flow rate is less than 0.1 ml per 5 minutes
Exclusion criteria:
Patients under radiation therapy
People with Sjögren's syndrome
People with cancer
People who take xerogenic drug (antiretroviral, antihistamine, anticholinergic, narcotic anticancer, tricyclic antidepressant, anti-inflammatory, anti-congestion drugs)
Patients under other treatments of xerostomia ( salivary stimulants, electrical stimulation, acupuncture, and the use of saliva substitutes).
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
28
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
before-after
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Guilan University of Medical Sciences
Street address
Guilan University of Medical Sciences, across Padideh and Khazar Restaurants, Fouman - Saravan Ring Road
City
Rasht
Province
Guilan
Postal code
4194173774
Approval date
2017-02-19, 1395/12/01
Ethics committee reference number
IR.GUMS.REC.1395.314
Health conditions studied
1
Description of health condition studied
xerostomia
ICD-10 code
K11.7
ICD-10 code description
Disturbances of salivary secretion
Primary outcomes
1
Description
Salivary flow rate
Timepoint
5 minutes before and after treatment every other day
Method of measurement
amount (volume and weigh ) of saliva
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 980nm Diod laser was applied bilaterally on submandibular glands and parotid glands extra orally (6j , 300mW, for 20 seconds) and it was applied intraorally on sublingual glands ( 4j , 2000mW, for 20 seconds) every other day for 10 sessions.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Lijariki and Aliabad Health Houses; Health Network of Bandar-e Anzali
Lorestan University of Medical Sciences, Anooshirvan Rezaei Square, Khoram Abad, Lorestan, Iran.
City
Khoram Abad
Province
Lorestan
Postal code
6814989468
Phone
+98 66 3320 7826
Email
derikvand27124@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rasht University of Medical Sciences
Proportion provided by this source
80
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Persons
Person responsible for general inquiries
Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Maryam Basirat
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Guilan University of Medical Sciences, across Padideh and Khazar Restaurants, Fouman - Saravan Ring Road
City
Rasht
Province
Guilan
Postal code
4194173774
Phone
+98 13 3348 6422
Fax
Email
maryam_basirat18@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Maryam Basirat
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Guilan University of Medical Sciences, across Padideh and Khazar Restaurants, Fouman - Saravan Ring Road
City
Rasht
Province
Guilan
Postal code
4194173774
Phone
+98 13 3348 6411
Fax
+98 13 3348 6423
Email
maryam_basirat18@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Maryam Basirat
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Guilan University of Medical Sciences, across Padideh and Khazar Restaurants, Fouman - Saravan Ring Road
City
Rasht
Province
Guilan
Postal code
4194173774
Phone
+98 13 3348 6411
Fax
+98 13 3348 6423
Email
maryam_basirat18@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Only the information on the main outcome will be published.
When the data will become available and for how long
Six months after the publication of the article.
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
The use of data for systematic studies or meta-analysis will be possible.
From where data/document is obtainable
I will provide it to the researchers of academic and scientific institutions via e-mail.
What processes are involved for a request to access data/document
The application should be sent to the researcher or vice chancellor of the Guilan University of medical sciences in an official letter which is approved by the Vice-Chancellor of her /his academic institution.