Evaluation of the effect of Thyme and Mint herbal tea on Salivary PH
Design
Clinical trial with control group, double blind, randomized, phase 2, sample size 60
Settings and conduct
This simple double blind (analyzer, volunteer)clinical trial study performed on 20-30 years-old Zahedan dental students. mint and thyme plant demos are prepared and filtered in specified dilutions.from study subjects asked to refrain from eating and drinking 90 minutes before the test.The minimum interval between consuming mint and thyme is 1 day. the unstimulated saliva were collected before min use fot 3 minutes , every 60 seconds . Then re-sampling 1, 5 and 10 min after consuming 150 ml of non-sweetening juice in separate tubes and assessed the pH of the saliva by PH meter .Then stop mint use,on the second day, the unstimulated saliva were collected before using thyme demon, within 3 minutes and every 60 seconds , and half hour later re-sampling 1, 5 and 10 min after 150 ml of non-sweetening deminus in separate tubes and assessed salivary pH . Data is recorded.
Participants/Inclusion and exclusion criteria
dental students aged 20 - 30 year old Inclusion criteria : No systemic disease, no history of drug use in the past 3 months No infection or acute or chronic dental or periodontal abscess No salivary gland disorders such as sjogren, stones, infection, neoplasm No histories of radiotherapy, tobacco use and drugs Do not use intraoral devices such as orthodontic plaque No oral lesions and no periodontal problems Exclusion criteria: uncooperate the age under 20 and over 30 years
Intervention groups
Mint consumer group and thyme consumer group
Main outcome variables
The Effect of mint and thyme consumption on the dental caries decreasing-salivary ph
General information
Reason for update
Acronym
-
IRCT registration information
IRCT registration number:IRCT20191012045067N6
Registration date:2022-12-09, 1401/09/18
Registration timing:retrospective
Last update:2022-12-09, 1401/09/18
Update count:0
Registration date
2022-12-09, 1401/09/18
Registrant information
Name
masoomeh shirzaiy
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 54 3321 1135
Email address
shirzaiy@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-11-01, 1401/08/10
Expected recruitment end date
2022-12-01, 1401/09/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of Thyme and Mint herbal tea on Salivary PH
Public title
Evaluation of the effect of Thyme and Mint herbal tea on Salivary PH
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
No systemic disease, ,
no history of drug use in the past 3 months,
no infection or acute or chronic dental or periodontal abscesses
no salivary gland disorders such as, stones, infection, neoplasms,
no intravenous radiotherapy,
no history of smoking and drug use
no history of Oral plaque use such as orthodontic plaque,
no oral lesions
no periodontal problems
Exclusion criteria:
Unwillingness to cooperate
Age over 30 years
Age
From 20 years old to 30 years old
Gender
Male
Phase
N/A
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Random assignment of participants to two groups is done by simple randomization method. In this way, the samples of eligible clients are assigned to the desired group based on blocks of 4 (consisting of two groups A and B and two repetitions for each) that will be randomly selected from among all the possible states of permutations. These blocks were created using statistical software R version 4.0.2 (Table 1).
Table 1: The practical method of assigning students to two groups with a simple randomization method
BAAB
AABB
BAAB
ABBA
BBAA
ABAB
AABB
ABBA
ABBA
AABB
ABAB
AABB
AABB
ABBA
BBAA
AABB
BAAB
BABA
BBAA
AABB
Blinding (investigator's opinion)
Double blinded
Blinding description
The participant and analyzer do not know the type of consumables and the consumables are numbered as 1 , 2.The substance is given to the participant in a glass with a coding matte lid and the analyzer records information only based on the desired code
Placebo
Not used
Assignment
Parallel
Other design features
-
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
دانشگاه علوم پزشکی زاهدان
Street address
azadegan street-dental school
City
zahedan
Province
Sistan-va-Balouchestan
Postal code
98176996930
Approval date
2022-07-26, 1401/05/04
Ethics committee reference number
IR.ZAUMS.REC.1401.146
Health conditions studied
1
Description of health condition studied
The effect of mint and thyme tea consumption on salivary pH
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
salivary PH rate
Timepoint
Before use, 1.5 and 10 minutes after use
Method of measurement
ph meter
Secondary outcomes
1
Description
salivary ph change
Timepoint
Before starting the study - 1, 5 and 10 minutes after the intervention
Method of measurement
Digital ph meter device
Intervention groups
1
Description
Intervention mint group In this group ,the participant receives mint tea(the composition of 100 grams of Saharkhiz mint powder in 250cc boiled water) in 1 dose ( once)
Category
Other
2
Description
Intervention group: thyme(the composition of 100 grams of Saharkhiz thyme powder in 250 cc boiled water)-In this group, the participant receives thyme tea in 1 dose(once)
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Zahedan dental school
Full name of responsible person
masoomeh shirzaiy
Street address
Azadegan street- Zahedan dental school
City
zahedan
Province
Sistan-va-Balouchestan
Postal code
9817699693
Phone
+98 54 3344 1814
Email
shirzaiy@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
somaye ansari moghaddam
Street address
Azadegan street -Zahedan dental school
City
zahedan
Province
Sistan-va-Balouchestan
Postal code
9817699693
Phone
+98 54 3344 1824
Email
ma_sarani2000@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
no
Proportion provided by this source
1
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Other
Person responsible for general inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
معصومه شیرزایی
Position
هیات علمی
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Azadegan-dental school
City
zahedan
Province
Sistan-va-Balouchestan
Postal code
9817699693
Phone
+98 54 3344 1824
Email
shirzaiy@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
masoomeh shirzaiy
Position
faculty
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Azadegan-Dental school
City
zahedan
Province
Sistan-va-Balouchestan
Postal code
9817699693
Phone
+98 54 3344 1824
Email
shirzaiy@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
masoomeh shirzaiy
Position
faculty
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
azadegan street-dental school
City
zahedan
Province
Sistan-va-Balouchestan
Postal code
9817699693
Phone
+98 54 3344 1824
Email
shirzaiy@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD