Protocol summary

Summary
Objective: detection effect of Black tea and Green tea consumption on salivary PH. This analytical study is Clinical Trial. Inclusion criteria: 20-22 Years old healthy people who have consent to enter the study. People with a history of black tea consumption. Exclusive criteria: systemic disease, acute or chronic infection and dental or periodontal abscess, salivary gland disorders, history of radiation therapy, smoking, addiction, pregnancy. The statistical population consisted of 50 volunteers from Zahedan Dental School students. In this study, all volunteers will be invited to consume black tea on the first day and after collecting saliva samples (in the manner described below), it will be replaced with Green tea (3-4 cups per day) and after that, in the second day before and after consuming Green tea samples will be collected again. For sampling, on the first day (8-9 A.M) we will ask each volunteer, before consuming Black tea, trickle their unstimulated saliva into the test tubes through his lower lip within 3 minutes and every 60 seconds (in seated position) and after half an hour recollect the samples 1, 5 and 10 minutes after ingestion of 250 ml Black tea without any sweetener in separate tubes (For each volunteer, test tubes numbered 1 to 4) and it will be transferred to laboratory to evaluate salivary PH. Then ask volunteers to replace Black tea with Green tea on that day. On the second day (8-9 A.M) we will ask each volunteer, before consuming Green tea, trickle their unstimulated saliva into the test tubes through his lower lip within 3 minutes and every 60 seconds (in seated position) and after half an hour recollect the samples 1, 5 and 10 minutes after ingestion of 250 ml Green tea without any sweetener in separate tubes (For each volunteer, test tubes numbered 1 to 4) and it will be transferred to laboratory to evaluate salivary PH. In the laboratory amount of salivary pH will be measured by digital PH-meter.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014102119599N2
Registration date: 2014-12-13, 1393/09/22
Registration timing: prospective

Last update:
Update count: 0
Registration date
2014-12-13, 1393/09/22
Registrant information
Name
Masoumeh Shirzai
Name of organization / entity
School of Dentistry, Zahedan
Country
Iran (Islamic Republic of)
Phone
+98 54 1242 9483
Email address
dr.shirzai@zaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Zahedan University of Medical Sciences
Expected recruitment start date
2015-01-28, 1393/11/08
Expected recruitment end date
2015-02-27, 1393/12/08
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation effect of Black and Green tea consumption on Salivary PH
Public title
Comparison of the effect of Black and Green tea consumption on Dental and Oral Health
Purpose
Other
Inclusion/Exclusion criteria
20-22 Years old healthy people who have consent to enter the study. People with a history of black tea consumption. Exclusion criteria: systemic disease, history of drug use in the past 3 months, acute /chronic dental or periodontal abscess, salivary gland disorders, such as Sjogren's, stones, infection, malignancy, history of radiation therapy, smoking, drugs, pregnancy, and the use of intraoral appliances such as orthodontic appliances
Age
From 20 years old to 22 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 50
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
Hesabi.Sq
City
Zahedan
Postal code
Approval date
2014-09-28, 1393/07/06
Ethics committee reference number
93/4/1223

Health conditions studied

1

Description of health condition studied
Dental caries
ICD-10 code
K02.0
ICD-10 code description
Caries limited to enamel

Primary outcomes

1

Description
Salivary PH
Timepoint
Before tea consumption and 1, 5 and 10 minutes after tea consumption
Method of measurement
by PH meter

Secondary outcomes

empty

Intervention groups

1

Description
Consumption 250 ml infused Zarin Green tea (Ceylon London)
Category
N/A

2

Description
Consumption 250 ml infused Zarin Black tea (Ceylon London)
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
School of Dentistry, Zahedan
Full name of responsible person
Vahid Moradi Lar
Street address
City
Gachsaran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Zahedan University of Medical Sciences
Full name of responsible person
Hamidreza Mahmoodzade Sagheb
Street address
Zahedan University of Medical Sciences, Faculty of Medicine, Department of Histology
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
School of Dentistry, Zahedan
Full name of responsible person
Dr.Masoumeh Shirzai
Position
Assistant Professor, Board Oral Disease
Other areas of specialty/work
Street address
Azadegan.St
City
Zahedan
Postal code
Phone
00
Fax
Email
shirzaiy@gmail.comdr.shirzai@zaums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
School of Dentistry, Zahedan
Full name of responsible person
Dr.Masoumeh Shirzai
Position
Assistant Professor, Board Oral Disease
Other areas of specialty/work
Street address
Azadegan.St
City
Zahedan
Postal code
Phone
+98 54 1242 9483
Fax
Email
shirzaiy@gmail.com dr.shirzai@zaums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
School of Dentistry, Zahedan
Full name of responsible person
Vahid Moradi Lar
Position
Student
Other areas of specialty/work
Street address
Danesh.St
City
Zahedan
Postal code
Phone
00
Fax
Email
vahid_moradi6666@hotmail.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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