Background and aim: Mutans streptococci are one the basic microorganisms that influence in dental caries process. Every year much money spends to treat and repair caries teeth. One of the methods to decrease saliva mutans is to chew xylitol gum to increase saliva rate and decrease the mutans streptococci rate in the mouth .This study is performed to determine the effect of xylitol gum on the saliva streptococci rate in children who have been admitted dental branch of Islami Azad Universiyt in 2013. Material and methods: This study is performed experimentally and is investigated 30 children in 10-12 years old who are admitted in pediatric and orthodontic departments of dental branch in Islamic Azad University. The cases had not any systemic disease and active caries cavities and periodontitis , they have not used any antibiotic medication and they are not regular users of gum (i.e. 4 pieces daily).They have not experienced orthodontic treatment and are not fluoride mouth wash users , Initially we will culture mutans streptococci in saliva samples of the cases. We ordered the culture results from minimum to maximum amount and randomly divide them in 3 groups of 10 .Group A: is given gum with xylitol, group B: is given gum base, group C: control group (has nothing to chew) after 30 days, the cases attended in saliva sampling process again. In this study the amount of saliva mutans streptococci at the first day and after 30 days is calculated and the changes will be analyzed by krus-kalvalis test. Also the decreasing mutans rate will be calculated by K2 .
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013010111960N1
Registration date:2013-02-13, 1391/11/25
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-02-13, 1391/11/25
Registrant information
Name
Nasim Shafiezadeh
Name of organization / entity
Islamic Azad University, Dental branch
Country
Iran (Islamic Republic of)
Phone
+98 21 2256 4571
Email address
n_shafiezadeh@dentaliau.ac.ir
Recruitment status
Recruitment complete
Funding source
researchers
Expected recruitment start date
2013-01-09, 1391/10/20
Expected recruitment end date
2013-02-08, 1391/11/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of chewing Xylitol gum on saliva mutans streptococci in children
Public title
The effect of Xylitol gum
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion Criteria: 10-12 year children; their parents have given informed consent; streptococcus mutans in saliva>10000, fasting from 2 hours before saliva sampling; being accessible for saliva sampling in 11 am. Exclusion Criteria: chewing gum usually (4 piece a day or more); using fluoride mouthwash or topical fluoride therapy or any kind of antibiotic therapy in last 3 months ; any systemic illness; any periodontal disorder; any obvious cavity in their teeth; using probiotic products in their usual diet; orthodontic therapy.
Age
From 10 years old to 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Islamic Azad University, Dental Branch
Street address
NO5 ,Niestan 10, Pasdaran
City
Tehran
Postal code
Approval date
2011-12-11, 1390/09/20
Ethics committee reference number
د/768/ب
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
Saliva mutans Streptococci
Timepoint
before and one mouth after
Method of measurement
Saliva mutans Streptococci is cultured on mitis salivaris agar and samples with more than 10,000 CFU are choosed
Secondary outcomes
empty
Intervention groups
1
Description
Intervention: chewing 1 piece Dr Xylitol chewing gum after each meal everyday (3 piece a day)
Category
Prevention
2
Description
Control1: chewing 1 piece gum base (saghez) after each meal (3 piece a day)
Category
Placebo
3
Description
Control 2: No intervention
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Dental Branch,Islamic Azad University
Full name of responsible person
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
personally
Full name of responsible person
Dr Nasim Shafiezadeh
Street address
Pediatric department,Dental Branch,Islamic Azad university
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
personally
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
Pediatric Dep.Dental Branch, Islamic Azad University