The effects of pure mastic gums, mastic gums enriched with probiotics and mastic gums with xylitol on the number of Mutans streptococci, Lactobacilli and PH of saliva
The aim of the study is to investigate the effect of pure mastic gums, mastic gums enriched with probiotics and xylitol added mastic gums on the number of Mutans streptococci, Lactobacilli and PH of saliva. 42 healthy volunteer dental students (20-30years old) are asked to brush their teeth using a similar toothbrush and toothpaste for two weeks. Afterwards the saliva samples will be collected and the Mutans streptococci count, Lactobacilli count and the PH of saliva will be recorded. The subjects will be randomly assigned to three equally sized groups, who chew one of three types of mastic gums (probiotic enriched, xylitol added or pure mastic gum) three times daily,5 minutes each time, for three weeks. Unstimulated saliva will be collected again for each person after mastic gums consumption period. The numbers of mutans streptococci and Lactobacilli and also the PH of each saliva sample will be measured. The data will be analyzed using statistical tests.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201110267910N1
Registration date:2012-01-15, 1390/10/25
Registration timing:prospective
Last update:
Update count:0
Registration date
2012-01-15, 1390/10/25
Registrant information
Name
Mina Biria
Name of organization / entity
Shaheed Beheshti Dental School
Country
Iran (Islamic Republic of)
Phone
+98 21 2990 2304
Email address
dr.biriam@dent.sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Shahid Beheshti dental school
Expected recruitment start date
2012-01-19, 1390/10/29
Expected recruitment end date
2012-01-26, 1390/11/06
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of pure mastic gums, mastic gums enriched with probiotics and mastic gums with xylitol on the number of Mutans streptococci, Lactobacilli and PH of saliva
Public title
The effects of pure mastic gums, mastic gums enriched with probiotics and mastic gums with xylitol on cariogenic microflora and PH of saliva
Purpose
Prevention
Inclusion/Exclusion criteria
Including criteria: 1) Dental students with the mean age of 25 years old; 2) Teeth brushing twice a day using fluoridated toothpaste. Excluding criteria: 1) history of systemic disease; 2) habitual use of xylitol or probiotic containing products; 3) previous use of systemic antibiotics and fluoride products at least four weeks before starting the study; 4) Existence of untreated carious teeth, gingivitis and periodontal diseases.
Age
From 20 years old to 30 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
42
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee, Shahid Beheshti University of Medical Sciences
Street address
Daneshjoo blvd, Evin
City
Tehran
Postal code
Approval date
2010-06-12, 1389/03/22
Ethics committee reference number
101
Health conditions studied
1
Description of health condition studied
Caries
ICD-10 code
B99
ICD-10 code description
Other and unspecified infectious diseases
Primary outcomes
1
Description
Lactobacilli count of saliva
Timepoint
before and three weeks after intervention
Method of measurement
colony count(cfu)
2
Description
PH of saliva
Timepoint
before and three weeks after intervention
Method of measurement
numerical value according to the reading of PH meter
3
Description
Mutans Streptococci count of saliva
Timepoint
before and three weeks after intervention
Method of measurement
colony count(cfu)
Secondary outcomes
empty
Intervention groups
1
Description
chewing xylitol containing mastic gum, three times a day after meal, 5 minutes each time
Category
Prevention
2
Description
chewing pure mastic gum, three times a day after meal, 5 minutes each time
Category
Prevention
3
Description
chewing probiotic enriched mastic gum, three times a day after meal, 5 minutes each time
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beheshti Dental School
Full name of responsible person
Dr. Mina Biria, Dr. Gita Eslami
Street address
Pediatric dentistry Department, Shahid Beheshti Dental School, Daneshjoo blvd, Evin
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Shahid Beheshti Dental School
Full name of responsible person
Mr. Farhadi, Dr. Vahid Dastgerdi
Street address
Pediatric Dentistry Department, Shahid Beheshti Dental School, Daneshjoo blvd., Evin
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Shahid Beheshti Dental School
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
Shahid Beheshti Dental School
Full name of responsible person
Dr. Mina Biria
Position
Board of pediatric Dentistry-Associate professor
Other areas of specialty/work
Street address
Pediatric dentistry department, Shahid Beheshti dental school, Daneshjoo blvd., Evin
City
Tehran
Postal code
Phone
+98 21 2990 2304
Fax
+98 21 8851 3649
Email
dr.biriam@dent.sbmu.ac.ir , dr.biriam@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti Dental School
Full name of responsible person
Dr. Mina Biria
Position
Board of Pediatric Dentistry-Associate professor
Other areas of specialty/work
Street address
Pediatric Dentistry Department, Shahid Beheshti Dental School, Daneshjoo Blvd., Evin
City
Tehran
Postal code
Phone
+98 21 2990 2304
Fax
+98 88513649
Email
dr.biriam@dent.sbmu.ac.ir , dr.biriam@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Pediatric Dentistry Departmant, Shahid Beheshti Dental School
Full name of responsible person
Dr. Mina Biria
Position
Associate Professor
Other areas of specialty/work
Street address
Pediatric Dentistry Departmant, Shahid Beheshti Dental School, Daneshjoo blvd., Evin
City
Tehran
Postal code
1533673513
Phone
+98 21 8874 7022
Fax
+98 21 8851 3649
Email
dr.biriam@dent.sbmu.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)