Aim: a comparison of the effectiveness of the two interventions in the prevention of early childhood caries.
Methods and Materials: this study performed on 239 participants containing 2 to 3 year-old children and their mothers registered in public health centers in Tehran. Inclusion criteria were age of child which was 24-36 months and registration in public health center. Child excluded from the study if his/her mother refused to participate. Nine centers selected according to stratified random sampling and randomly allocated to two intervention groups and one control group. At baseline, mothers were interviewed for filling out two behavioral questionnaires; then, child’s teeth were examined by two trained examiners using WHO and ICDAS methods. Plaque index was evaluated before dental exam and dental plaque was conducted to transfer medium. Group A and group B received oral and written(pictured) behavioral education and fluoridated varnish, respectively. Group C was control group and did not receive any intervention. Three months later, mothers were interviewed through phone call for behavioral changes. Six months later, mothers filled out the same two behavioral questionnaires and children were examined for dental caries and dental plaque. The reduction of dental caries, dental plaque and counts of mutant streptococcus and behavior change of mothers were primary outcomes of this study.
Shahid Beheshti University of Medical Sciences- dental school
Country
Iran (Islamic Republic of)
Phone
+98 21 2242 1813
Email address
h.toutouni@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2012-04-10, 1391/01/22
Expected recruitment end date
2013-01-22, 1391/11/03
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparison of the effectiveness of the two interventions in the prevention of "Early childhood caries".
Public title
A comparison of the two methods for prevention of tooth decay in young children.
Purpose
Prevention
Inclusion/Exclusion criteria
inclusion criteria: age of children was more than 24 months and less than 36 months; mothers and their children enrolled in child health program at public health centers of Tehran.
exclusion criteria: mother and children who do not want to participate in study.
Age
From 2 years old to 3 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
239
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shahid Beheshti University of Medical Sciences
Street address
central building, Daneshjoo blv, Evin
City
Tehran
Postal code
19834
Approval date
2011-01-30, 1389/11/10
Ethics committee reference number
614
Health conditions studied
1
Description of health condition studied
dental caries
ICD-10 code
K02.8
ICD-10 code description
other dental caries
Primary outcomes
1
Description
new dental caries lesion
Timepoint
6 months after intervention
Method of measurement
clinical examinination
Secondary outcomes
1
Description
Mutants Streptococcus colony
Timepoint
6 months after baseline
Method of measurement
counting in lab
Intervention groups
1
Description
Behavioral intervention is performed using self determination theory/model through oral and written (pictured) statements at baseline and six months later. Three months after baseline, mothers interview through phone call and all the questions are answered by health provider during six month study, if any.
Statements developed according to American Academy of Pediatric Dentistry's guideline for the prevention of early childhood caries considering self determination theory/ model structure to promote autonomy, competency and relatedness of mothers.
Category
Behavior
2
Description
Professional intervention using fluoridated varnish applied on surfaces of the teeth at baseline and six months later.
Mothers interview through phone call three months after baseline examination to measure their behavior change.
Category
Prevention
3
Description
Control group received no intervention. Three months after baseline, mothers interview through phone call to measure their behavior change.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Hediyeh Toutouni
Street address
dental school, shahid beheshti university, daneshjoo blv, evin
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Abdolhamid Zafarmand
Street address
dental school, shahid beheshti university, daneshjoo blv, evin
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid beheshti dental school
Full name of responsible person
Hediyeh Toutouni
Position
resident- Ph.D degree
Other areas of specialty/work
Street address
dental school, shahid beheshti university, daneshjoo blv, evin
City
Tehran
Postal code
19834
Phone
+98 21 2242 1813
Fax
+98 22421813
Email
h.toutouni@sbmu.ac.ir, h_toutouni@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
dental school, shahid beheshti university
Full name of responsible person
Hediyeh Toutouni
Position
resident- Ph.D degree
Other areas of specialty/work
Street address
shahid beheshti university, daneshjoo blv, evin
City
Tehran
Postal code
19834
Phone
+98 21 2242 1813
Fax
+98 22421813
Email
h.toutouni@sbmu.ac.ir h_toutouni@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
dental school- shahid beheshti university
Full name of responsible person
Hediyeh Toutouni
Position
resident- Ph.D degree
Other areas of specialty/work
Street address
shahid beheshti university, daneshjoo blv, evin
City
Tehran
Postal code
19834
Phone
+98 21 2242 1813
Fax
+98 22421813
Email
h.toutouni@sbmu.ac.ir h_toutouni@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)