Protocol summary

Study aim
Determining the effect of two combined herbal mouthwashes (containing Thymus, Myrtus, Glycyrrhiza and Aloe Vera) and chlorhexidine 0.2% on saliva pH
Design
20 students enter the study. While fasting for 90 minutes, on the first day, unstimulated saliva is collected by spitting, then 20 ml of orange juice is swirled in the mouth for 1 minute and saliva is collected again. In the next step, they are divided into two equal groups, and group A is given a combined herbal mouthwash, and group B is given chlorhexidine mouthwash for 1 minute, and saliva is collected in the above-mentioned manner, and at the end of the first day, the pH of these samples is measured and will be recorded . After 72 hours of washing out, these steps are repeated again, with the difference that the type of mouthwash of the two groups is changed and the pH of the collected saliva samples is measured again. A phase 0 study is considered a trial
Settings and conduct
In Qazvin Dental Faculty, measuring the pH of saliva samples with a pH meter, double blinding
Participants/Inclusion and exclusion criteria
Qazvin dental faculty students Student willingness and satisfaction to participate in the study Not suffering from any systemic diseases that affect saliva such as diabetes and thyroid diseases - Not using drugs, smoking, alcohol and drugs - Not using anticholinergic drugs, antihypertensives, antidepressants, etc. - Not having a history of radiotherapy; Not using intra-oral devices such as placardodontics Exclusion criteria : lack of satisfaction and lack of proper cooperation of the student
Intervention groups
Two groups of 10 people who receive combined herbal mouthwash and chlorhexidine mouthwash and the type of mouthwash is changed in a cross-over manner.
Main outcome variables
sex Age Type of mouthwash Saliva pH

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240406061420N1
Registration date: 2024-05-30, 1403/03/10
Registration timing: prospective

Last update: 2024-05-30, 1403/03/10
Update count: 0
Registration date
2024-05-30, 1403/03/10
Registrant information
Name
Fazeleh Barani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 902 110 2966
Email address
fazelebarani1379@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-06-01, 1403/03/12
Expected recruitment end date
2024-06-20, 1403/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment of the effect of the combined herbal mouthwash (containing Thymus, Myrtus, Glycyrrhiza and Aloe Vera) and Chlorhexidine (0.2%) on salivary pH and flow rate
Public title
Assessment of the effect of the combined herbal mouthwash (containing Thymus, Myrtus, Glycyrrhiza and Aloe Vera) and Chlorhexidine (0.2%) on salivary pH and flow rate
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Not suffering from any systemic diseases that affect saliva such as diabetes and thyroid diseases - Not using drugs, smoking, alcohol and drugs - Not using anticholinergic drugs, antihypertensives, antidepressants, etc. - Not having a history of radiotherapy - Not using intraoral devices such as orthodontic plates
Exclusion criteria:
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
  • Participant
  • Care provider
Sample size
Target sample size: 20
More than 1 sample in each individual
Number of samples in each individual: 2
Saliva sample after using herbal mouthwash and after using chlorhexidine mouthwash
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are assigned to two treatment groups, B and A, using the method of random blocks (balance block randomization). The size of each block is 10 and the total number of blocks is 2. Balanced randomization allocation method for the participants in the randomized crossover clinical trial study in the first group (A) the effect of using 0.2% chlorhexidine mouthwash after one minute and after 20 minutes on saliva pH and in the second group (B) the effect of using The combined herbal mouthwash is checked after one minute and after 20 minutes on saliva pH
Blinding (investigator's opinion)
Double blinded
Blinding description
When the participants receive the mouthwashes, they do not know the type of mouthwash received, the data analyst also only knows after receiving the data that two types of mouthwashes are being compared and is unaware of their contents.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Qazvin University of Medical Sciences
Street address
Bahonar Blvd., Qazvin medical science university
City
Qazvin
Province
Qazvin
Postal code
1
Approval date
2024-03-17, 1402/12/27
Ethics committee reference number
IR.QUMS.REC.1402.415

Health conditions studied

1

Description of health condition studied
Salivary pH
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Salivary pH
Timepoint
Sampling is done in two days with a time interval of 72 hours
Method of measurement
pH meter

Secondary outcomes

empty

Intervention groups

1

Description
The group receiving combined herbal mouthwash
Category
Prevention

2

Description
The group receiving chlorhexidine mouthwash 0.2%
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Qazvin university of medical science
Full name of responsible person
Fazeleh Barani
Street address
Bahonar Blvd.
City
Qazvin
Province
Qazvin
Postal code
1
Phone
+98 902 110 2966
Email
fazelebarani1379@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Mahdie Zarabadipour
Street address
Bahonar Blvd., Qazvin university of medical science
City
Qazvin
Province
Qazvin
Postal code
1
Phone
+98 902 110 2966
Email
fazelebarani1379@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Qazvin university of medical science
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
Qazvin University of Medical Sciences
Full name of responsible person
Fazeleh Barani
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Bahonar Blvd
City
Qazvin
Province
Qazvin
Postal code
1
Phone
+98 902 110 2966
Fax
Email
fazelebarani1379@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Mahdie Zarabadipour
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Bahonar Blvd
City
Qazvin
Province
Qazvin
Postal code
1
Phone
+98 902 110 2966
Email
fazelebarani1379@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Fazeleh
Position
student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Bahonar Blvd., Qazvin
City
Qazvin
Province
Qazvin
Postal code
1
Phone
+98 902 110 2966
Email
fazelebarani1379@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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