Protocol summary

Study aim
Evaluation of the effect of Oolong tea on the mean salivary pH of Students of Gorgan Faculty of Dentistry in 2024
Design
Clinical trial with two arm parallel group, randomized and double blind
Settings and conduct
After determining the salivary pH of the participants, a person who is aware of the numbering of the glasses and the block allocation of the numbers provides them to the participants. To prepare tea, 4 grams of dry oolong tea is poured into 150 ml of boiling water. After putting the lid on the container for three to five minutes, we pass the solution through the filter. 150 ml of boiling water is used to prepare the placebo. 150 ml of each substance (oolong tea or placebo) was separated and after reaching room temperature, the distributor gave it to the participants without knowing the contents of each glass. Due to the fact that containers with non-transparent lids are used, the candidate will not notice the color of oolong tea or placebo. Sampling will be done in the Department of Oral and Dental Diseases of Gorgan Faculty of Dentistry between 10 AM and 12 PM. Volunteers are asked to comfortably swallow a glass of oolong tea or placebo. For sampling, each person is asked to pour their immobilized saliva (in a sitting position) into the test tube through the lower lip within 3 minutes and every 60 seconds before consuming tea, 1, 5 and 10 minutes after consuming tea. Sampling will be done in separate tubes. A digital pH meter will be used to evaluate saliva pH.
Participants/Inclusion and exclusion criteria
Willingness to participate in the study, Systemically healthy, Not taking medicine in the past month, Having good oral hygiene, Absence of gingivitis, periodontitis and active tooth decay. ​
Intervention groups
Oolong tea/placebo group
Main outcome variables
Salivary pH

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240205060918N1
Registration date: 2024-05-11, 1403/02/22
Registration timing: registered_while_recruiting

Last update: 2024-05-11, 1403/02/22
Update count: 0
Registration date
2024-05-11, 1403/02/22
Registrant information
Name
Niloofar Minoochehr
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 17 3255 2018
Email address
n.minoochehr@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-05-03, 1403/02/14
Expected recruitment end date
2024-07-18, 1403/04/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the Effect of Oolong Tea on the Mean Salivary pH of Students of Gorgan Faculty of Dentistry: A Double-blind Randomized Controlled Clinical Trial
Public title
Evaluation of the Effect of Oolong Tea on Saliva
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Students of Gorgan Faculty of Dentistry, 20-30 years old, healthy Willingness to participate in the study Systemically healthy Not taking medicine in the past month Having good oral hygiene Absence of gingivitis, periodontitis and active tooth decay
Exclusion criteria:
History of smoking, alcohol consumption, drugs consumption Having a medium to heavy plaque
Age
From 20 years old to 30 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
Sample size
Target sample size: 50
Randomization (investigator's opinion)
Randomized
Randomization description
50 healthy students of Gorgan Faculty of Dentistry aged between 20 and 30 who are eligible to the study will be selected by randomized sampling and after obtaining their informed consent, they will be distributed into two groups of 25 people by block randomization method. 50 random numbers will be generated with R software. The two groups will be as follows: Elang tea group: (1,5,9,10,11,21,41,38,12,29,13,23,43,34,2,3,8,31,17,30) Placebo group: (6,7,16,25,27,33,35,20,40,46,22,15,50,45,4,14,19,32,28,18)
Blinding (investigator's opinion)
Double blinded
Blinding description
This study is a double-blind randomized controlled clinical trial study, which the participants and distributors of the oolong tea and placebo are not aware of the arrangement of people in the groups.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Golestan University of Medical Sciences
Street address
Edalat 61th, Edalat Ave., Gorgan, Iran
City
Gorgan
Province
Golestan
Postal code
4917845656
Approval date
2024-01-27, 1402/11/07
Ethics committee reference number
IR.GOUMS.REC.1402.434

Health conditions studied

1

Description of health condition studied
evaluation of the mean salivary pH
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
the salivary pH mean
Timepoint
At the beginning of the study (before the start of the intervention), 1, 5 and 10 minutes after consuming oolong tea
Method of measurement
pH meter

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group (oolong tea): 4 grams of dry oolong tea is poured into 150 ml of boiling water (according to the manufacturer's instructions). After putting the lid on the container for three to five minutes, we pass 150 ml of the solution through the filter and allow it to cool and reach room temperature (20 to 25 degrees Celsius).
Category
Prevention

2

Description
Control group (placebo): To prepare the placebo, 150 ml of boiled water that has been cooled down to room temperature (20 to 25 degrees Celsius) is used.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Department of Oral and Dental Diseases of Gorgan Faculty of Dentistry
Full name of responsible person
Sudabeh Bagheri Moghadam
Street address
Shahriar 5th, Shahrisr Ave., Gorgan, Iran
City
Gorgan
Province
Golestan
Postal code
4913983632
Phone
+98 17 3262 7823
Email
dr.baqerymoqadam@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Deputy of research and technology
Street address
Shariar 5th, Shahriar Ave.
City
Gorgan
Province
Golestan
Postal code
4913983632
Phone
+98 17 3255 0565
Email
s.shabani8791@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Gorgan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Niloofar Minoochehr
Position
Dentistry student
Latest degree
Master
Other areas of specialty/work
Dentistry
Street address
Edalat 61th, Edalat Ave.
City
Gorgan
Province
Golestan
Postal code
4917845656
Phone
+98 17 3252 2018
Email
n.minoochehr@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Niloofar Minoochehr
Position
Dentistry student
Latest degree
Master
Other areas of specialty/work
Dentistry
Street address
Edalat 61th, Edalat Ave.
City
Gorgan
Province
Golestan
Postal code
49178455656
Phone
+98 17 3252 2018
Email
n.minoochehr@gmail.cm

Person responsible for updating data

Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Niloofar Minoochehr
Position
Dentistry student
Latest degree
Master
Other areas of specialty/work
Dentistry
Street address
Eadalat 61th, Edalat Ave.
City
Gorgan
Province
Golestan
Postal code
4917845656
Phone
+98 17 3255 2018
Email
n.minoochehr@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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