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Evaluation of the release amount of chitosan and the effect of it on the pH of saliva after consuming chitosan-based gum: a clinical trial study

Protocol summary

Study aim
Determination of chitosan release rate in saliva and its effect on saliva pH after consuming chitosan-based chewing gum
Design
Clinical trial without control group, before and after comparison , without blinding and randomization on 30 patients
Settings and conduct
In one day, 2cc saliva sample will be taken from all volunteers before consuming chewing gum and two hours after eating breakfast without any stimulation by spitting method in a closed container. volunteers should brush their teeth immediately after eating breakfast and should not eat, drink or chew gum after that. In order to prevent any undesirable chemical changes saliva samples will be stored in a ice-containing container and will be sent to the Laboratory of Avicenna University within one hour to quantify the amount of chitosan and measure the pH . Then, volunteers will be given a piece of chewing gum containing chitosan and their saliva is collected in 10, 20 and 30 minutes after chewing in the specified falcon tubes for each time.
Participants/Inclusion and exclusion criteria
In this study, 30 students and staff of Hamadan Dental School will be included in the study. In one day, a saliva sample of 2 cc will be taken from all volunteers before consuming chewing gum and two hours after eating breakfast without any stimulation by spitting in a closed container. Candidates should brush their teeth immediately after eating breakfast and should not eat, drink or chew gum after that
Intervention groups
Each volunteer is given a piece of chitosan-containing gum and asked to spit into Falcon tubes designated for each time, once before chewing and then 10, 20, and 30 minutes after chewing the gum. In total, each volunteer will chew a gum for 30 minutes.
Main outcome variables
pH of saliva, Quantification of chitosan released in saliva

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230611058451N1
Registration date: 2023-07-30, 1402/05/08
Registration timing: prospective

Last update: 2023-07-30, 1402/05/08
Update count: 0
Registration date
2023-07-30, 1402/05/08
Registrant information
Name
mohadese shokripour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 81 3838 1085
Email address
shokripour557@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-09-15, 1402/06/24
Expected recruitment end date
2023-09-21, 1402/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the release amount of chitosan and the effect of it on the pH of saliva after consuming chitosan-based gum: a clinical trial study
Public title
Evaluation of the release amount of chitosan and the effect of it on the pH of saliva after consuming chitosan-based gum
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Have good oral hygiene. Have at least 24 healthy teeth (5 teeth in each quadrant of the jaw).
Exclusion criteria:
Has antibiotics in the last 6 months. Being a smoker. Using mouthwash. Having systemic disease. Having any sign of periodontal disease. Having an orthodontic device or any prothesis in his/her mouth.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 30
More than 1 sample in each individual
Number of samples in each individual: 4
Each volunteer is given a piece of chitosan-containing gum and asked to spit their saliva into Falcon tubes designated for each time, once before chewing and then 10, 20, and 30 minutes after chewing the gum. In total, each volunteer will chew a gum for 30 minutes.
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Comparison before and after the intervention

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Hamedan University of Medical Sciences
Street address
Shahid Fahmideh Blvd. , Pazhouhesh Square
City
Hamedan
Province
Hamadan
Postal code
6517838736
Approval date
2023-04-08, 1402/01/19
Ethics committee reference number
IR.UMSHA.REC.1402.022

Health conditions studied

1

Description of health condition studied
Dental Caries
ICD-10 code
K02
ICD-10 code description
Dental caries

Primary outcomes

1

Description
Quantification of chitosan released in saliva
Timepoint
Measuring the amount of chitosan in saliva 10, 20 and 30 minutes after starting to consume gum.
Method of measurement
Ninhydrin Method

2

Description
pH of saliva
Timepoint
Measuring saliva pH before the intervention and 10, 20 and 30 minutes after the start of chewing gum
Method of measurement
Strip Method

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: a piece of chewing gum containing 20% chitosan made by Shoko Prasto company, which will be chewed for 30 minutes.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Hamedan University of Medical Sciences
Full name of responsible person
Mohadese Shokripour
Street address
Shahid Fahmideh Blvd. , Pazhouhesh Square
City
Hamedan
Province
Hamadan
Postal code
6517838736
Phone
+98 81 3131 0000
Email
webda@umsha.ac.ir
Web page address
https://www.umsha.ac.ir/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Reza Shokoohi
Street address
Shahid Fahmideh Blvd. , Pazhouhesh Square
City
Hamedan
Province
Hamadan
Postal code
6517838736
Phone
+98 81 3131 4058
Email
shokoohi@yahoo.com
Web page address
https://research.umsha.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan University of Medical Sciences
Proportion provided by this source
90
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

2

Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Mohadese Shokripour
Street address
Shahid Fahmideh Blvd. , Pazhouhesh Square
City
Hamedan
Province
Hamadan
Postal code
6517838736
Phone
+98 81 3131 0000
Email
webda@umsha.ac.ir
Web page address
https://www.umsha.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan University of Medical Sciences
Proportion provided by this source
10
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
Hamedan University of Medical Sciences
Full name of responsible person
Mohadese Shokripour
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Shahid Fahmideh Blvd. , Pazhouhesh Square
City
Hamedan
Province
Hamadan
Postal code
6517838736
Phone
+98 81 3131 0000
Email
shokripour557@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Mohadese Shokripour
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Hamedan University of Medical Sciences (UMSHA), dental school, Shariati Crossroad., Hamadan, Iran
City
Hamedan
Province
Hamadan
Postal code
6517838736
Phone
+98 81 3838 1085
Fax
Email
shokripour557@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Mohadese Shokripour
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Hamedan University of Medical Sciences (UMSHA), dental school, Shariati Crossroad., Hamadan, Iran
City
Hamedan
Province
Hamadan
Postal code
6517838736
Phone
+98 81 3838 1085
Fax
Email
shokripour557@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
The amount of chitosan released into saliva and pH of saliva
When the data will become available and for how long
Access starts from 1404
To whom data/document is available
Researchers working in academic, scientific and industrial institutions
Under which criteria data/document could be used
Making chewing gum to reduce the rate of dental caries
From where data/document is obtainable
Hamadan University of Medical Sciences, Faculty of Dentistry or E-Mail
What processes are involved for a request to access data/document
At least 2 weeks
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