Effect of Vitamin E on Antioxidant Capacity of Saliva (TAC) of Smokers and Non-Smokers and Comparison with Each Other
Design
Thirty smokers and 30 nonsmokers were randomly divided into two subgroups. Subgroup A and Subgroup B. The study is designed as a cross over. . The samples in this study were randomly selected from two groups and from eligible referral clients. The study is conducted in two parallel subgroups. The study will be double-blind and the study participants and the person providing the drug and the sample collector will be kept blind. The laboratory is aware of the sample type and group. The use of the nonsmoker group has a control group aspect in the study.
Settings and conduct
Subgroup A smokers and non-smokers in the first phase of vitamin E 200 IU daily intake for 3 weeks. Subgroup B smokers and non-smokers in the first phase of placebo take a similar treatment to the original drug for 3 weeks. Thereafter, two subgroup A will take placebo for three weeks and two subgroup B will take vitamin E three weeks.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Smoking at least 5 cigarettes per day or 5 cigarette packs per year
Inclusion criteria for non-smokers: Non-smoking during 3 years ago
Exclusion criteria: Systemic underlying disease and medication use three weeks before the study
Intervention groups
two groups : Smokers and Non-Smokers using Vit E 200 IU and Placebo
Main outcome variables
Numerical value and mean total salivary antioxidant capacity of the two groups
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20110428006322N3
Registration date:2021-03-05, 1399/12/15
Registration timing:retrospective
Last update:2021-03-05, 1399/12/15
Update count:0
Registration date
2021-03-05, 1399/12/15
Registrant information
Name
Mostafa Rezaee
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1635 6681
Email address
rezaim@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2015-12-22, 1394/10/01
Expected recruitment end date
2016-04-20, 1395/02/01
Actual recruitment start date
2016-04-20, 1395/02/01
Actual recruitment end date
2016-07-22, 1395/05/01
Trial completion date
2017-02-19, 1395/12/01
Scientific title
Evaluation and comparison of the effect of vitamin E on salivary total antioxidant capacity in smokers and non-smokers patients
Public title
Evaluation of the effect of vitamin E on saliva of smokers
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Smokers with the history of 5 or more pack/year of smoking
the smoker patients referred to Nader Kazemi Dental Clinic of Shiraz city
Exclusion criteria:
individuals with systemic diseases, dry mouth, history of oral ulcer or any inflammatory oral diseases, alcohol consumption, drug and medication use or supplemental vitamin consumption in the last three months
patients with age over 65 years old
Age
From 30 years old to 70 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Sample size
Target sample size:
30
Actual sample size reached:
30
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, we will use the Restricted randomization method of block randomization. All blocks are the same size as 6, and made by two groups (including 3 participants in the intervention group and 3 participants in the control group). Random allocation software is used to make random sequence (Random allocation software). For allocation concealment, non-transparent sequentially numbered envelopes will be used. In order to maintain the random sequence, numbering is done on the outer surface of the envelopes. Finally, the lids of the letter envelopes will be glued and placed inside a box, respectively. At the beginning of the registration of participants, based on the order of entry of eligible participants in the study, one of the envelopes of the letter will be opened in order and the assigned group of the participant will be revealed.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this single-blind study, the participants in the study are kept blind. The laboratory is aware of the sample type and group.
Placebo
Used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz university of medical sciences
Street address
Shiraz university of medical sciences, Zand blvd
City
Shiraz
Province
Fars
Postal code
71345-1978
Approval date
2016-08-20, 1395/05/30
Ethics committee reference number
IR.SUMS.REC.1395.209
Health conditions studied
1
Description of health condition studied
smoking , Total Antioxidant Capacity , Oral cancer prevention
ICD-10 code
ICD-10 code description
Z58.7
Primary outcomes
1
Description
Total Antioxidant Capacity
Timepoint
Measurement of total salivary antioxidant capacity in the saliva sample of all participants was collected in the first stage before the intervention, 3 weeks after the intervention, then wash out and again 3 weeks later (equivalent to 6 weeks after the start of the intervention). And the measurement is done.
Method of measurement
20 ml of non-stimulated saliva in the sitting position during the period of 9 A.M to 12 A.M collected. The participants spitting in a 50ml. Falcon tube every 60 seconds. According to the status of the participants 5-15 minutes between each time spit break out. Sample stored at 0 to 5 ° C temperature. Samples were centrifuged (Sigma-Germany) at 4000 rpm. , 4 ° C for 10 minutes. Then centrifuged sample carried out by Pasteur Pipette (ISO-Lab, Germany) and placed in 2 ml tubes (ISAN Teb -Iran) in a freezer (Jal tajhiz-Iran) at -70 ° C. Fluorescence recovery after photobleaching (FRAP) technique used to measurement of total antioxidant capacity of samples. This method is based on the ability of saliva to recover ferric ions to the ferrite in the presence of a substance called TPTZ ( 2,4,6-Tri(2-pyridyl)-s-triazine), which is used as a reagent, resulting in a blue complex of TPTZ-Fe with a maximum absorption of 593 nm. The amount of salivary oxidation/reduction capacity measured by the concentration of the TPTZ-Fe blue complex by spectrophotometer at 593 nm.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Smokers between the ages of 30 and 70 years old who take a daily dose of 200 IU vitamin E product from Dana Drug Company orally for three weeks.
Category
Diagnosis
2
Description
Control group: Smokers between the ages of 30- 70 years old who take placebo medication made by Dana Pharmaceutical Company and similar to the main drug daily for 3 weeks.
Category
Diagnosis
3
Description
Intervention group: Non smokers between the ages of 30 - 70 years old who take a daily dose of 200 IU vitamin E product from Dana Drug Company orally for three weeks.
Category
Diagnosis
4
Description
Control group: Non Smokers between the ages of 30- 70 years old who take placebo medication made by Dana Pharmaceutical Company and similar to the main drug daily for 3 weeks.
Category
Diagnosis
Recruitment centers
1
Recruitment center
Name of recruitment center
Nader Kazemi dental clinic
Full name of responsible person
Mostafa Rezaee
Street address
Vali Asr Square - Dept. of Square - Faculty of Dentistry, Shiraz University of Medical Sciences
City
Shiraz
Province
Fars
Postal code
29.608424
Phone
+98 71 3725 8091
Email
mostafarezaee857@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Fatemeh Mohamadi
Street address
Ghasrdasht blvard, Qom Abad , dentistry faculty
City
Shiraz
Province
Fars
Postal code
71345-1836
Phone
+98 71 3626 3192
Email
rezaim@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
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
Not applicable
Title and more details about the data/document
In this study, due to the confidentiality of the individual data of the participants, only the executive protocol, data analysis method, and general plan information are shared in the article.
When the data will become available and for how long
starting 6 months after publication
To whom data/document is available
his only available for people working in academic institutions
Under which criteria data/document could be used
only for research and treatment propose
From where data/document is obtainable
email address
What processes are involved for a request to access data/document
Send an email to the planner and contact person to receive the required information. In the absence of the problem, the information required will be less than 2 weeks