Protocol summary

Summary
current single clinical trial is planned to evaluation of effect of lycopene on salivary antioxidant system in cell phone users.30 patients who consulting Zahedan dentistry collage and use cell phone more than 5 years and more than 20 minutes daily,will be chosen voluntary.patients shouldn't eat or drink for 1 hour and then collect their salivary with spitting method.asking them to save salivary in 2 minutes,then centrifugus(2500 cycle per minute) them for 10 minutes that debries take apart.pure salivary sample will be stored in -70 c.volunteers should use 1 lycopene tablet(15mg) vitabiobicts' product daily for 1 month and after 1 month we should sampling again.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201703043133N10
Registration date: 2017-06-06, 1396/03/16
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-06-06, 1396/03/16
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
Vice chancellor for research of Zahedan University of Medical Sciences
Expected recruitment start date
2017-04-04, 1396/01/15
Expected recruitment end date
2017-09-06, 1396/06/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evalouation of the effect of lycopene on salivary antioxidant system in cell phone users
Public title
Evalouation of the effect of lycopene on saliva in cell phone users
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria:users of cell phone at least for 5 years;more than 20 minutes daily Exclusion criteria:drugs;smoking; alcohol consumption ;chronic systemic diseases;truma; xerostomia;history of head and neck radiotherapy and chemotherapy;people under 18 years;using nutritional supplements;periodontal diseases;using handsfree
Age
No age limit
Gender
Both
Phase
4
Groups that have been masked
No information
Sample size
Target sample size: 30
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Zahedan University of Medical Sciences
Street address
Persian Golf Blvd., University campus
City
zahedan
Postal code
Approval date
2017-01-26, 1395/11/07
Ethics committee reference number
ir.zaums.rec.1395.268

Health conditions studied

1

Description of health condition studied
salivary antioxidant system
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
total antioxidant capacity
Timepoint
day0,day 30
Method of measurement
measuring with spectrophotometer

Secondary outcomes

empty

Intervention groups

1

Description
tablet lycopene 10 mg daily for 30 days
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Dental school of Zahedan
Full name of responsible person
Dr.Fateme Arbabi Kalati
Street address
dentistry college,eastern Azadagan street, Zahedan
City
Zahedan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Zahedan University of Medical Sciences
Full name of responsible person
Dr Hoshang Rafighdost
Street address
University campus, Persian Golf Blvd., Zahedan
City
Zahedan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, 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. Fateme Arbabi-Kalati
Position
Associated Professor
Other areas of specialty/work
Street address
Dentistry College, Eastern Azadagan street
City
Zahedan
Postal code
Phone
+98 54 1244 1824
Fax
Email
F kalati@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
Fateme Arbabi-Kalati
Position
Assistant Professer of Oral medicine
Other areas of specialty/work
Street address
Dentistry College, Eastern Azadagan Street, Zahedan
City
Zahedan
Postal code
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
Dr. Fateme Arbabi Kalati
Position
Associate Professor
Other areas of specialty/work
Street address
Dentistry College, Eastern Azadagan Street, Zahedan
City
zahedan
Postal code
Phone
+98 54 1244 1824
Fax
Email
F kalati@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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