Investigating and comparing the amount of saliva pH changes following the use of 0.5 and 1% arginine mouthwash as a clinical trial
Design
A clinical trial with two parallel groups, without a control group, double-blind, randomized, phase 1 on 24 patients. Sealed envelopes will be used for randomization.
Settings and conduct
Twenty-four eligible children will enter the study. 0.5 and 1% arginine mouthwashes will be prepared and labelled A on the 0.5% mouthwashes and B on the 1% mouthwashes. On 12 cards, tag A, and on the other 12 cards, tag B is written and will place inside the sealed envelopes. On the test day, the responsible personnel will randomly open an envelope and use the mouthwash specified for the participant. At the beginning of the experiment and before using the mouthwashes, 1 ml of unstimulated saliva of the participants will be collected in an upright position. Then the participants will gargle 10 ml of the indicated mouthwash for 1 minute. Then 1 ml of their unstimulated saliva will be collected 5, 10, 15, and 20 minutes after using the mouthwash in an upright position. Then the pH of the collected saliva samples will be measured with a digital pH meter.
Participants/Inclusion and exclusion criteria
Twenty-four 6-12 years-old children who are healthy without systemic disease and with intact teeth free from caries and periodontal disease, who have not taken any antibiotics in the last four weeks, will be included in the study.
Intervention groups
Group A: 0.5% arginine mouthwash,Group B: 1% arginine mouthwash
Main outcome variables
Saliva pH
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230728058947N1
Registration date:2023-08-09, 1402/05/18
Registration timing:registered_while_recruiting
Last update:2023-08-09, 1402/05/18
Update count:0
Registration date
2023-08-09, 1402/05/18
Registrant information
Name
Mehrnaz Mahmoodabadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 4422 9142
Email address
mahmoodabadimehrnaz@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-08-01, 1402/05/10
Expected recruitment end date
2023-11-11, 1402/08/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the amount of salivary pH changes following the use of arginine mouthwash: a randomized clinical trial
Public title
Investigating the effect of arginine mouthwash on salivary pH
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Healthy children aged 6 to 12 without systemic disease
Children with intact teeth, that are free from caries and enamel lesions and periodontal disease
Children who have not taken any antibiotics in the last 4 weeks
Exclusion criteria:
Children with systemic diseases
Children with decayed teeth or structural problems in the enamel
Children who have taken antibiotics in the last four weeks
Age
From 6 years old to 12 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Sample size
Target sample size:
12
Randomization (investigator's opinion)
Randomized
Randomization description
A sealed envelope was used for randomization
Blinding (investigator's opinion)
Double blinded
Blinding description
The participants, the personnel responsible for providing mouthwash to the participants, the saliva sample collector, and the statistics expert were unaware of the percentage of mouthwash on the day of the experiment, and the groups of mouthwash named A and B were provided to them.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee in Medical Research, Faculty of Dentistry, Shahid Beheshti University of Medical Sc
Street address
Building No. 2, Second Floor,Shahid Shahriari Square, Student Blvd., Shahid Arabi Street, Shahid Beheshti University of Medical Sciences Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
19395-4631
Approval date
2022-12-10, 1401/09/19
Ethics committee reference number
IR.SBMU.DRC.REC.1401.076
Health conditions studied
1
Description of health condition studied
saliva pH
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Saliva pH
Timepoint
Before using mouthwash, 5, 10, 15 and 20 minutes after using mouthwash
Method of measurement
Using digital pH meter
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 1% arginine mouthwash
Category
Prevention
2
Description
Intervention group: 0.5% arginine mouthwash
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Department of Pediatrics, School of Dentistry, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mehrnaz Mahmoodabadi
Street address
Building No. 2, Second Floor,Shahid Shahriari Square, Student Blvd., Shahid Arabi Street, Shahid Beheshti University of Medical Sciences Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
19395-4631
Phone
+98 21 2243 9872
Email
Mahmoodabadimehrnaz@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Fahimeh Kooshki
Street address
Building No. 2, Second Floor,Shahid Shahriari Square, Student Blvd., Shahid Arabi Street, Shahid Beheshti University of Medical Sciences Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
19395-4631
Phone
+98 21 2243 9872
Email
sec.bms@acecr.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mehrnaz Mahmoodabadi
Position
pediatric dentistry resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Building No. 2, Second Floor,Shahid Shahriari Square, Student Blvd., Shahid Arabi Street, Shahid Beheshti University of Medical Sciences Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
19395-4631
Phone
+98 21 2243 9872
Email
Mahmoodabadimehrnaz@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mehrnaz Mahmoodabadi
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Building No. 2, Second Floor,Shahid Shahriari Square, Student Blvd., Shahid Arabi Street, Shahid Beheshti University of Medical Sciences Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
19395-4631
Phone
+98 21 2243 9872
Email
mahmoodabadimehrnaz@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mehrnaz Mahmoodabadi
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Building No. 2, Second Floor,Shahid Shahriari Square, Student Blvd., Shahid Arabi Street, Shahid Beheshti University of Medical Sciences Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
19395-4631
Phone
+98 21 2243 9872
Email
mahmoodabadimehrnaz@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