The aim of this randomized controlled study was to investigate the effects of chlorhexidine and probiotic on the modified oral microflora stability. 105 children aged 6-12 years old were assigned into one of following groups. Group 1 received chlorhexidine, 0.12% mouthwash twice daily for 2 weeks; group 2 received probiotic yogurt containing Lactobacilli at a concentration of 2 × 108 CFU/g for 3 weeks; and group 3 received chlorhexidine 0.12% mouthwash twice daily for 2 weeks and after 24 hours they received probiotic yogurt containing Lactobacilli at a concentration of 2 × 108 CFU/g for 3 weeks. Salivary Streptococcus mutans and Lactobacilli were counted one day, one week, and five weeks after each intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138902183893N1
Registration date:2009-07-20, 1388/04/29
Registration timing:retrospective
Last update:
Update count:0
Registration date
2009-07-20, 1388/04/29
Registrant information
Name
Naser Aasl Aminabadi
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1335 5965
Email address
n-aminabadi@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Sciences
Expected recruitment start date
2009-07-20, 1388/04/29
Expected recruitment end date
2009-09-30, 1388/07/08
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the modified oral microflora stability using chlorhexidine and probiotic in 6-12 years old children
Public title
Evaluation of the modified oral microflora stability using chlorhexidine and probiotic in 6-12 years old children
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: No systematic disease, receiving no medications, not receving any antibiotics or xilytol-containing chewing gums within 4 week prior to the study
Exclusion criteria: salivary SM count lower than 105CFU/ml
Age
From 6 years old to 12 years old
Gender
Both
Phase
4
Groups that have been masked
No information
Sample size
Target sample size:
105
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee Research on Humans, Tabriz University of Medical Sciences
Street address
Tabriz University of Medical Sciences, Tabriz, Iran
City
Tabriz
Postal code
Approval date
2010-04-20, 1389/01/31
Ethics committee reference number
893
Health conditions studied
1
Description of health condition studied
Dental carries
ICD-10 code
k02, k02.3
ICD-10 code description
dental carries, arested dental carries, other dental carries,dental carries unspecified
Primary outcomes
1
Description
salivary Streptococcus mutans counts
Timepoint
at 24-hour, one-week, and five-week intervals after cessation of probiotic
Method of measurement
Saliva sampling and microbial evaluation
Secondary outcomes
1
Description
Lactobacilli counts
Timepoint
at 24-hour, one-week, and five-week intervals after cessation of probiotic
Method of measurement
Saliva sampling and microbial evaluation
Intervention groups
1
Description
chlorhexidine 0.12% mouthwash twice daily for 2 weeks; + probiotic yoghurt containing Lactobacilli at a concentration of 2 × 108 CFU/g for 3 weeks
Category
Treatment - Drugs
2
Description
received chlorhexidine 0.12% mouthwash twice daily for 2 weeks
Category
Treatment - Drugs
3
Description
probiotic yoghurt containing Lactobacilli at a concentration of 2 × 108 CFU/g
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Department of Pediatric Dentistry, School of Dentistry
Full name of responsible person
Street address
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Naser Asl Aminabadi
Street address
Department of Paediatric Dentistry, School of Dentistry, Tabriz University of Medical Sciences,
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Akram Ebrahimi
Position
DDS, Postgraduate student
Other areas of specialty/work
Street address
Department of Pediatric Dentistry, School of Dentistry, Tabriz University of Medical Sciences
City
Tabriz
Postal code
Phone
+98 41 1335 5969
Fax
Email
ebrahimi_pd@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
School of Dentistry, Tabriz University of Medical
Full name of responsible person
Naser Asl Aminabadi
Position
DDS, MSc, Associate professor
Other areas of specialty/work
Street address
Department of Pediatric Dentistry, School of Dentistry, Tabriz University of Medical Sciences
City
Tabriz
Postal code
Phone
+98 41 1335 5965
Fax
+98 41 1334 6977
Email
aslaminabadi@Gmail.comn-aminabadi@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
School of Dentistry, Tabriz University of Medical Sciences
Full name of responsible person
Naser Asl Aminabadi
Position
DDS, MSc, Associate professor
Other areas of specialty/work
Street address
Department of Pediatric Dentistry, School of Dentistry, Tabriz University of Medical Sciences
City
Tabriz
Postal code
Phone
+98 41 1335 5965
Fax
+98 41 1334 6977
Email
aslaminabadi@Gmail.comn-aminabadi@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)