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IRCT20110428006322N3 IRCT 2021-03-05 Shiraz University of Medical Sciences Evaluation of the effect of vitamin E on saliva of smokers Evaluation and comparison of the effect of vitamin E on salivary total antioxidant capacity in smokers and non-smokers patients 2015-12-22 anticipated 30 Complete https://irct.ir/trial/42244 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Crossover, Purpose: Treatment, 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 description: In this single-blind study, the participants in the study are kept blind. The laboratory is aware of the sample type and group. 2-3 smoking , Total Antioxidant Capacity , Oral cancer prevention. Intervention 1: 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. Intervention 2: 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. Intervention 3: 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. Intervention 4: 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. Yes - There is a plan to make this available What will be shared: 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: starting 6 months after publication To whom: his only available for people working in academic institutions Conditions: only for research and treatment propose Where to obtain: email address How to obtain: 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 Comments:
public Mostafa Rezaee
dentistry faculty. ghomabad ave. Ghasrdasht blvd
Shiraz Iran (Islamic Republic of) 713451836 +98 71 3626 3192 rezaim@sums.ac.ir Shiraz University of Medical Sciences scientific Mostafa rezaie
dentistry university. ghomabad ave. ghasrdasht blvd
Shiraz Iran (Islamic Republic of) 713451836 +98 71 3626 3192 rezaim@sums.ac.ir Shiraz University of Medical Sciences Iran (Islamic Republic of) Smokers with the history of 5 or more pack/year of smoking the smoker patients referred to Nader Kazemi Dental Clinic of Shiraz city 30 years 70 years Both 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 Z58.7 Diagnosis Diagnosis Diagnosis Diagnosis 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. 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. 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. 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. 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. Shiraz University of Medical Sciences Approved 2016-08-20 Ethics committee of Shiraz university of medical sciences Shiraz university of medical sciences, Zand blvd Shiraz Fars Iran (Islamic Republic of)