Evaluation of effect of Tea tree oil and Alvoevera mouthwash on Salivary PH level
Design
Crossover clinical trial, random assignment of 20 participants to 10 dual blocks, phase 3, random allocation software was used for randomization.
Settings and conduct
Qazvin dental students will enter the study if they are eligible. First, pH of the patient's non-stimulatory saliva is measured. Then, patient's PH of the saliva is measured after rinsing 20 ml of orange juice in the mouth for one minute. Then, patients are randomly divided into two equal groups by random block method and both groups receive interventions in a crossover design. After each intervention, salivary pH measurements are repeated immediately and 20 minutes later. No blinding is performed in this study.
Participants/Inclusion and exclusion criteria
Inclusion criteria: students of the Faculty of Dentistry of Qazvin University of Medical Sciences in the age range of 25-18 years. Exclusion criteria: systemic diseases affecting saliva such as diabetes, hypertension, thyroid disease; smoking and drug abuse; Taking anticholinergic, antihypertensive, antidepressants; history of radiotherapy; use of Intraoral appliance as orthodontic device.
Intervention groups
First Intervention group : First, 20 ml of orange juice is rinsed in the mouth for one minute and then the tea tree oil - aloe vera irsha mouthwash is rinsed in the mouth for one minute. After 72 hours of wash out,the 0.2% Irsha chlorhexidine mouthwash is rinsed in the mouth for one minute. Intervention group 2: First, 20 ml of orange juice is rinsed in the mouth for one minute and then chlorhexidine 0.2% Irsha mouthwash is rinsed in the mouth for one minute. After 72 hours of wash out, the Aloe Vera Irsha Tea Tree Oil mouthwash is rinsed in the mouth for one minute.
Main outcome variables
Salivary pH
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211104052964N1
Registration date:2022-05-14, 1401/02/24
Registration timing:prospective
Last update:2022-05-14, 1401/02/24
Update count:0
Registration date
2022-05-14, 1401/02/24
Registrant information
Name
Fatemeh Vahdat Bivarzani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 28 3256 6445
Email address
f.vahdatbivarzani@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-05-26, 1401/03/05
Expected recruitment end date
2022-07-21, 1401/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of two mouthwashes: Tea tree oil _ Alvoevera and Chlorhexidine 0/2 % on Salivary PH level
Public title
Evaluation of effect of mouthwashes on Salivary PH level
Purpose
Basic scienece
Inclusion/Exclusion criteria
Inclusion criteria:
Dentistry students of Qazvin University of Medical Sciences in the age range of 18-25 years
Exclusion criteria:
Having systemic diseases affecting saliva such as diabetes, hypertension and thyroid diseases
Smoking and drugs abuse
Taking anticholinergic, antihypertensive, antidepressant drugs
History of radiotherapy
Using intraoral devices such as orthodontic appliance
Age
From 18 years old to 25 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
20
More than 1 sample in each individual
Number of samples in each individual:
6
This study incloudes 20 participants and saliva will be collected from each participant 6 times. Thus: 1- PH of saliva of participants at the beginning of work 2- PH of saliva after rinsing 20 ml of orange juice 3- PH of saliva immediately after rinsing 1 minute 5 ml of the first mouthwash 4-PH of saliva 20 minutes after that 5-PH of saliva immediately after rinsing 1 minute 5 ml of the second mouthwash 6-PH of saliva 20 minutes after that
Randomization (investigator's opinion)
Randomized
Randomization description
The 20 participants of the study are divided into two groups A and B using random allocation software using random block method. The size of each block is 2 and the total number of blocks is 10.Balanced random allocation method for participants in a randomized clinical trial study is used to evaluate the effect of two mouthwashes of tea tree oil and aloe vera and chlorhexidine on saliva pH.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Crossover
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
Deputy of research and technology ,The first sub,Mavedat Alley, Shahid Beheshti Boulevard
City
Qazvin
Province
Qazvin
Postal code
3415613911
Approval date
2021-09-15, 1400/06/24
Ethics committee reference number
IR.QUMS.REC.1400.261
Health conditions studied
1
Description of health condition studied
salivary Ph
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
PH level of saliva
Timepoint
Saliva pH is measured at the beginning of the study and after orange juice and immediately and 20 minutes after using mouthwashes.
Method of measurement
Digital PH Meter Device
Secondary outcomes
empty
Intervention groups
1
Description
First intervention group: participants rinse 5 milliliter of Irsha Tea Tree Oil _ Aloe Vera Mouthwash, which contains Poloxamer 407, Isopropyl myristate,Thymol, Sorbitol, Menthol, Eucalyptus, Tea Tree Oil, Aloe Vera , Xylitol, Authorized Cosmetic Essential Oil, Sorbate, Thymol , Sodium benzoate, Potassium sorbate, Citric acid, Cetylpyridinium chloride, Sodium fluoride, Color CL.42090, CL.19140 and Deionized water once in their mouth for 1 minute. After 72 hours of wash out, participants rinse 5 milliliter of Irsha chlorhexidine 0.2% mouthwash which contains chlorhexidine digluconate, xylitol, Cetylpyridinium chloride, menthol, citric acid, deionized water, polysorbate , color CL.16035 and color CL.17200- once in their mouth for 1 minute.
Category
Treatment - Drugs
2
Description
Second Intervention group: participants rinse 5 milliliter of Irsha chlorhexidine 0.2% mouthwash which contains chlorhexidine digluconate, xylitol, Cetylpyridinium chloride, menthol, citric acid, deionized water, polysorbate , color CL.16035 and color CL.17200- once in their mouth for 1 minute. After 72 hours of wash out, participants rinse 5 milliliter of Irsha Tea Tree Oil _ Aloe Vera Mouthwash, which contains Poloxamer 407, Isopropyl myristate,Thymol, Sorbitol, Menthol, Eucalyptus, Tea Tree Oil, Aloe Vera , Xylitol, Authorized Cosmetic Essential Oil, Sorbate, Thymol , Sodium benzoate, Potassium sorbate, Citric acid, Cetylpyridinium chloride, Sodium fluoride, Color CL.42090, CL.19140 and Deionized water once in their mouth for 1 minute.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Qazvin University of Medical Sciences
Full name of responsible person
Fatemeh Vahdat Bivarzani
Street address
School of Dentistry, Qazvin University of Medical Sciences, Shahid Bahonar Blvd, Qazvin
City
Qazvin
Province
Qazvin
Postal code
3415759811
Phone
+98 28 3256 6445
Fax
+98 28 3335 3066
Email
dentfaculty@qums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Dr.Mehdi Mirhashemi
Street address
Deputy of research and technology ,The first sub,Mavedat Alley, Shahid Beheshti Boulevard
City
Qazvin
Province
Qazvin
Postal code
3415613911
Phone
+98 28 3336 8124
Fax
+98 28 3335 0056
Email
researchdpt@qums.ac.ir
Web page address
https://vcr.qums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qazvin 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
Qazvin University of Medical Sciences
Full name of responsible person
Fatemeh Vahdat Bivarzani
Position
Collegian
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
First floor, number 5, Golbarg 6 alley, Rangin kaman street, 3rd area, mohammadiyeh
City
Qazvin
Province
Qazvin
Postal code
3491941359
Phone
+98 28 3256 6445
Fax
Email
f.vahdatbivarzani@qums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Fatemeh Vahdat Bivarzani
Position
Collegian
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
First floor, number 5, Golbarg 6 alley, Rangin kaman street, 3rd area, mohammadiyeh
City
Qazvin
Province
Qazvin
Postal code
3491941359
Phone
+98 28 3256 6445
Fax
Email
f.vahdatbivarzani@qums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Fatemeh Vahdat Bivarzani
Position
Collegian
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
First floor, number 5, Golbarg 6 alley, Rangin kaman street, 3rd area, mohammadiyeh
City
Qazvin
Province
Qazvin
Postal code
3491941359
Phone
+98 28 3256 6445
Fax
Email
f.vahdatbivarzani@qums.ac.ir
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