Protocol summary

Summary
The present study aimed to investigate the effect of vitamin C on defense system of saliva anti oxidant of patients with periodontal disease. Samples were chosen among people attending dentistry collage of Kermanshah, who were recognized for periodontal disease. It was a double blind clinical study. 32 patients with periodontal were selected and were divided to control and experiment groups. Samples of experimental group received 500 mg of oral vitamin C power daily for three weeks. Unstimulated saliva of patients was tested in the morning and patients were asked to brush their teeth and avoid eating and drinking at least 90 minutes before saliva test on the test day. Samples were sitting while saliva gathering process. After three weeks, saliva samples were again gathered from patients and total anti oxidant capacity was measured using Randox kit and the results were recorded. Samples of control group received water with permissible oral essence and color. Inclusion: written satisfaction by 20 patients; having at least teeth; propping depth deeper than 5 mm and clinical attachment level less than 3 mm at least 30 % of sites; bleeding while propping; chronic gum inflammation; systematically healthy patients; patient who had not received propping treatment during last 6 months. Exclusion: patients using antibiotics or anti inflammatory medicine; having systematic disease history; pregnant and breast feeding women; those who use vitamin supplements; those who use mouthwash; those who smoke.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014111714333N24
Registration date: 2014-12-23, 1393/10/02
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2014-12-23, 1393/10/02
Registrant information
Name
Feizollah Foroughi
Name of organization / entity
kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1821 4653
Email address
fforoughi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kermanshah University of Medical Sciences
Expected recruitment start date
2014-12-06, 1393/09/15
Expected recruitment end date
2015-01-05, 1393/10/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of using and avoiding to use vitamin C on defense system of saliva anti oxidant of periodontal patients
Public title
Study the effect of vitamin C on saliva antioxidant defense system of patients with periodontal disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion: written satisfaction by 20 patients; having at least teeth; propping depth deeper than 5 mm and clinical attachment level less than 3 mm at least 30 % of sites; bleeding while propping; chronic gum inflammation; systematically healthy patients; patient who had not received propping treatment during last 6 months. Exclusion: patients using antibiotics or anti inflammatory medicine; having systematic disease history; pregnant and breast feeding women; those who use vitamin supplements; those who use mouthwash; those who smoke.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 32
Randomization (investigator's opinion)
N/A
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
Kermanshah University of Medical Sciences
Street address
Building No.2, Shahid Beheshti, Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences
City
Kermanshah
Postal code
Approval date
2014-12-17, 1393/09/26
Ethics committee reference number
420/7/پ/40619

Health conditions studied

1

Description of health condition studied
Disease of salivary gland, unspecified
ICD-10 code
k11.9
ICD-10 code description
Disease of salivary gland, unspecified

Primary outcomes

1

Description
Saliva anti oxidant
Timepoint
At the beginning of study and three weeks after that
Method of measurement
Using Randox kit

Secondary outcomes

empty

Intervention groups

1

Description
Samples of experimental group received 500 mg of oral vitamin C power daily for three weeks. Unstimulated saliva of patients was tested in the morning and patients were asked to brush their teeth and avoid eating and drinking at least 90 minutes before saliva test on the test day. Samples were sitting while saliva gathering process. After three weeks, saliva samples were again gathered from patients and total anti oxidant capacity was measured using Randox kit and the results were recorded.
Category
Treatment - Drugs

2

Description
Samples of control group received 500 mg of water with permissible oral essence and color for three weeks. Unstimulated saliva of patients was first gathereded in the morning and patients were asked to brush their teeth and avoid eating and drinking at least 90 minutes before saliva test on the test day. Samples were sitting while saliva gathering process. After three weeks, saliva samples were again gathered from patients and total anti oxidant capacity was measured using Randox kit and the results were recorded.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Faculty of Dentistry
Full name of responsible person
Dr. Ana Behvand
Street address
Faculty of Dentistry, Gisha Building,Zare Alley, Shariati streets
City
Kermanshah

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences
Full name of responsible person
Koroush Hamzehee
Street address
Building No.2, Shahid Beheshti, Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences
City
Kermanshah
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 Affairs, Kermanshah 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

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Mahmood Rahmani
Position
PhD oral diseases
Other areas of specialty/work
Street address
Faculty of Dentistry, Gisha Building,Zare Alley, Shariati streets
City
Kermanshah
Postal code
Phone
00
Fax
Email
mahdental@yahoo.com
Web page address

Person responsible for updating data

Contact

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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