Comparison of the effect of casein phosphopeptide-amorphous calcium phosphate(CPP-ACP) and Xylitol Chewing gums and probiotic yogurt on streptocuccos mutans and microbial dental plaque
The propose of this study is to determine the effect of casein phosphopeptide-amorphous calcium phosphate (CPP-ACP) and Xylitol Chewing gums and probiotic yogurt on streptocuccos mutansand microbial dental plaque. In this randomized clinical trials 112 students of dentistry who have 22 teeth and good oral hygiene are attended. Exclusion criteria:
Systemic diseases that affect dental and periodental conditions; Orthodontic appliance; active dental caries; choronic mucosite; chronic antibiotic usage; antibacterial mouth rinse consumption; drugs consumption which affect saliva flow rate; radio therapy history
This 112 samples are randomly divided into 4 groups
Group 1: chewing 20 minutes Xylitol gum 3 times a day for 30 days.
Group 2: chewing 20 minutes CPP-ACP gum 3 times a day for 30 days.
Group 3:200 grams probiotic yogurt once a day for 30 days
Group4: 5 cc chlorhexidine mouth rinse every night for 15 days
at base line and before intervention plaque index is recorded and saliva of samples are taken and will be assessed for mutans count. Then after 15, 30 days of intervention, again plaque index and mutans saliva count will be recorded. For group 4 just after 15 days the plaque index and mutans saliva count will be recorded
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016100730193N1
Registration date:2017-06-26, 1396/04/05
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-06-26, 1396/04/05
Registrant information
Name
Iman Parisay
Name of organization / entity
Mashhad University of Medical Sciences-Mashhad Dental Faculty
Country
Iran (Islamic Republic of)
Phone
+98 51 3608 6977
Email address
parisayi@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor of Mashhad University of Medical Sciences
Expected recruitment start date
2017-01-20, 1395/11/01
Expected recruitment end date
2017-04-21, 1396/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of casein phosphopeptide-amorphous calcium phosphate(CPP-ACP) and Xylitol Chewing gums and probiotic yogurt on streptocuccos mutans and microbial dental plaque
Public title
Comparison of the effect ofcasein phosphopeptide-amorphous calcium phosphate (CPP-ACP) and Xylitol Chewing gums and probiotic yogurt on streptocuccos mutans and microbial dental plaque
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Dental students; have 22 teeth; good oral hygiene
Exclusion criteria:
systemic diseases that affect dental and periodental conditions; orthodontic appliance; active dental caries; choronic mucosite; chronic antibiotic usage; antibacterial mouth rinse consumption; drugs consumption which affect saliva flow rate; radio therapy history
Age
From 20 years old to 27 years old
Gender
Both
Phase
4
Groups that have been masked
No information
Sample size
Target sample size:
112
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
randomization table
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Mashhad University of Medical Sciences Ethics Committee
Street address
Mashhad Dental Faculty-Vakil Abbad Blvd
City
Mashhad
Postal code
Approval date
2017-02-08, 1395/11/20
Ethics committee reference number
IR.mums.sd.REC.1394.199
Health conditions studied
1
Description of health condition studied
dental Plaque-Stereptocucos mutans counts
ICD-10 code
Z01.2-k03.
ICD-10 code description
DENTAL EXAMINATION-Deposites on tooth
Primary outcomes
1
Description
human smutans streptococci counts in salive-Dental Plaque
Timepoint
base line -15 day-30 day
Method of measurement
Micobial culture-plaque index
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: chewing 20
minutes Xylitol gum 3 times a day for 30 days.
Category
Treatment - Drugs
2
Description
Intervention group 2: chewing 20
minutes CPP-ACP gum 3 times a day for 30 days
Category
Treatment - Drugs
3
Description
Intervention group 3:200 grams
probiotic yogurt once a day for 30 days
Category
Treatment - Drugs
4
Description
Control group 4: 5 cc chlorhexidine mouth
rinse every night for 15 days
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Mashhad Dental Faculty
Full name of responsible person
Dr.Iman Parisay
Street address
Mashhad Dental Faculty-Vakil Abbad BLVD
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research Vice chancellor of Mashhad University of Medical Sciences
Full name of responsible person
Dr.Mohsen Tafaghodi
Street address
Research Vice chancellor of Mashhad University of Medical Sciences -Daneshgah Street
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Vice chancellor of Mashhad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Mashhad Dental Faculty
Full name of responsible person
Dr.Iman Parisay
Position
Associate Professor of pediatric dentistry department
Other areas of specialty/work
Street address
Mashhad Dental Faculty-Vakil Abbad BLVD
City
Mashhad
Postal code
Phone
+98 51 3882 9501
Fax
Email
parisayi@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad Dental Faculty
Full name of responsible person
Dr.Iman Parisay
Position
Associate Professor of pediatric dentistry department
Other areas of specialty/work
Street address
Mashhad Dental Faculty-Vakil Abbad BLVD
City
Mashhad
Postal code
Phone
+98 51 3882 9501
Fax
Email
parisayi@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mashhad Dental Faculty
Full name of responsible person
Dr.Iman Parisay
Position
Associate professor of pediatric dentistry department
Other areas of specialty/work
Street address
Mashhad Dental Faculty-Vakil Abbad BLVD
City
Mashhad
Postal code
Phone
+98 51 3882 9501
Fax
Email
parisayi@mums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)