Protocol summary

Study aim
assessment the effect of two types of flavored chewing gum (Action and Biodent) on salivary pH and volume
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. From study subjects asked to refrain from eating and drinking 90 minutes before the test.The minimum time interval between Action gum and Biodent should be 1 day. Before consuming , unstimulated saliva is collected within 3 minutes and every 60 seconds, one hour before and after consumption, half an hour later, re-sampling is done 1, 5 and 10 minutes after consuming Biodent flavored gum in separate tubes, and pH of saliva is measured with a pH meter. Then the consumption of Biodent chewing gum is stopped and on the second day non-irritating saliva is collected before consumption and one hour after consumption of flavored action chewing gum, within 3 minutes and every 60 seconds and half an hour later re-sampling 1, 5 and 10 minutes after consuming a piece of gum, saliva is measured in separate tubes. The resulting information 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
action gum consumer group and biodent gum consumer group
Main outcome variables
The Effect of action and biodent flavored gum consumption on the dental caries decreasing-salivary ph

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20191012045067N7
Registration date: 2023-05-09, 1402/02/19
Registration timing: prospective

Last update: 2023-05-09, 1402/02/19
Update count: 0
Registration date
2023-05-09, 1402/02/19
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
2023-05-24, 1402/03/03
Expected recruitment end date
2023-07-27, 1402/05/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of two types of flavored chewing gum (Action and Biodent) on salivary pH and volume
Public title
Investigating the effect of two types of flavored chewing gum (Action and Biodent) on salivary pH and volume
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
Both
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, After referring people, one of them will be assigned to intervention group 1 and the other to intervention group 2
Blinding (investigator's opinion)
Double blinded
Blinding description
he 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 same cover with a coding 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
Zahedan University of Medical Sciences
Street address
azadegan street-dental school
City
zahedan
Province
Sistan-va-Balouchestan
Postal code
98176996930
Approval date
2023-02-26, 1401/12/07
Ethics committee reference number
IR.ZAUMS.REC.1402.006

Health conditions studied

1

Description of health condition studied
The quantity and quality of saliva
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 volume
Timepoint
Before starting the study - after the intervention
Method of measurement
ml/minute

Intervention groups

1

Description
Intervention group: 1: In this group ,the participant receives 1 biodent gum(cinamon) 1 once and chews gum for five minutes.
Category
Other

2

Description
Intervention group2: Intervention group: 1: In this group ,the participant receives 1 Action gum(cinamon) 1 once and chews gum for five minutes.
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
-
Proportion provided by this source
1
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
Other

Person responsible for general inquiries

Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Masoome Shirzaiy
Position
Associated Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Zahedan-Azadegan Street-Dental School
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9817699693
Phone
+98 54 3341 4005
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-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
There is no further information
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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