Comparative evaluation of the effects of casein phosphopeptide-amorphous calcium phosphate (CPP-ACP) and Xylitol-containing chewing gum on salivary flow rate, pH and concentration of calcium and phosphate
The effect of chewing gum containing CPP-ACP and xylitol on the volume and pH of saliva and the amount of calcium and phosphate ions present in saliva
Design
Three arm parallel group randomised trial,Randomised
Settings and conduct
This study is done at Yazd Dental School.In this study, after grouping two samples of saliva will be taken (before and after chewing gum). People should chew gum for 5 minutes
Participants/Inclusion and exclusion criteria
60 dental students with the following conditions:
Complete health systemically
Not having a special diet
No evidence of dry mouth
Not taking antibiotics and antacids two weeks before the test
No use of orthodontic plaque and prosthesis
No smoking, no pregnancy, no periodontal disease, no active caries
Intervention groups
Group 1: A piece of gum containing ACP-CPP with peppermint flavor
Group 2: One piece of Xylitol gum
Group 3: A piece of paraffin will be given
Main outcome variables
salivary flow rate, pH and concentration of calcium and phosphate
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20140601017935N8
Registration date:2019-12-14, 1398/09/23
Registration timing:prospective
Last update:2019-12-14, 1398/09/23
Update count:0
Registration date
2019-12-14, 1398/09/23
Registrant information
Name
Zahra Bahrololoomi
Name of organization / entity
Shahid Sadoughi University of Medical Sciences-Yazd
Country
Iran (Islamic Republic of)
Phone
+98 35 1624 0691
Email address
zbahrololoom@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-12-21, 1398/09/30
Expected recruitment end date
2020-01-19, 1398/10/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative evaluation of the effects of casein phosphopeptide-amorphous calcium phosphate (CPP-ACP) and Xylitol-containing chewing gum on salivary flow rate, pH and concentration of calcium and phosphate
Public title
Comparative evaluation of the effects of casein phosphopeptide-amorphous calcium phosphate (CPP-ACP) and Xylitol-containing chewing gum on salivary
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
تعداد 60 نفر از دانشجویان دندان پزشکی دارای سلامت کامل از لحاظ سیستمیک
Exclusion criteria:
داشتن رژیم غذایی خاص
افراد مبتلا به خشکی دهان تشخیص داده نشده
افرادی که آنتی بیوتیک و دارو های آنتی اسید دو هفته قبل از شروع آزمایش مصرف کردند
استفاده از پلاک ارتودنسی و پروتز
استعمال سیگار
بارداری
داشتن بیماری پریودنتال
افرادی که پوسیدگی فعال نداشته باشند
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization
personal, using the random number table
Blinding (investigator's opinion)
Single blinded
Blinding description
The researcher does not know in which group each person belongs, and the outcome assessor is unaware of which group the samples were in.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shahid Sadoughi University of Medical Sciences
Street address
Central Organization for Shahid Sadoughi University of Medical Sciences, Bahonar S., Yazd
City
Yazd
Province
Yazd
Postal code
8916978477
Approval date
2019-09-23, 1398/07/01
Ethics committee reference number
IR.SSU.REC.1398.096
Health conditions studied
1
Description of health condition studied
chewing gum
ICD-10 code
ICD-10 code description
2
Description of health condition studied
chewing gum
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
changes in salivary flow rate, pH and concentration of calcium and phosphate
Timepoint
Before the intervention, immediately after the intervention
Method of measurement
Salivary volume will be measured by calibrated pipette, salivary pH using a calibrated digital pH meter, salivary calcium spectrophotometric method, salivary phosphate will be measured spectrophotometric method.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:First Intervention group : First,They will brush twice daily for 3 weeks with a toothbrush(Medical) and toothpaste(Nasim). On the sampling day they will not eat anything for 2 hours and then give them a chewing gum CCP-ACP (Trident Recaldent with The peppermint flavor) is given and after 5 minutes of chewing, the saliva is collected
Category
Other
2
Description
Intervention group: : second Intervention group : First,They will brush twice daily for 3 weeks with a toothbrush(Medical) and toothpaste(Nasim). On the sampling day they will not eat anything for 2 hours and then give them a chewing gum Xylitol (Trident) with The peppermint flavor is given and after 5 minutes of chewing, the saliva is collected
Category
Other
3
Description
Control group: First,They will brush twice daily for 3 weeks with a toothbrush(Medical) and toothpaste(Nasim). On the sampling day they will not eat anything for 2 hours and then give them a piece of paraffin is given and after 5 minutes of chewing, the saliva is collected
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
دانشکده دندانپزشکی دانشگاه علوم پزشکی شهید صدوقی یزد
Full name of responsible person
Arezoo Ghotbzade
Street address
Yazd,Dahe Fajr Blvd,Faculty of Dentistry
City
Yazd
Province
Yazd
Postal code
8914881167
Phone
+98 35 3625 5881
Fax
+98 35 3625 5881
Email
Arezoo.ghotbzade@yahoo.com
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
خانم خضری
Street address
Yazd,Dahe Fajr Blvd, Faculty of Dentistry
City
Yazd
Province
Yazd
Postal code
8914881167
Phone
+98 35 3625 5881
Fax
Email
pajoheshdentyazd@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd 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
Yazd University of Medical Sciences
Full name of responsible person
Arezoo Ghotbzade
Position
Dental student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Yazd, Dahe Fajr Blvd, Faculty of Dentistry
City
Yazd
Province
Yazd
Postal code
8914881167
Phone
+98 35 3625 5881
Email
arezoo.ghotbzade@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Dr. Zahra Bahrololoomi
Position
Associate professor of Pediatric Dentistry
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Yazd, Dahe Fajr Blvd,Faculty of Dentistry
City
Yazd
Province
Yazd
Postal code
8914881167
Phone
+98 35 3625 5881
Email
zbahrololoom@ssu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Arezoo Ghotbzade
Position
Dental student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Yazd, Dahe Fajr Blvd,Faculty of Dentistry
City
Yazd
Province
Yazd
Postal code
8914881167
Phone
+98 35 3625 5881
Email
Arezoo.ghotbzade@yahoo.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