Comparison the effectiveness of Fluoride Varnish and Oral Health Education on Prevention of Dental Caries in Primary teeth in Children under the Age of Three Years
The aim of this study was to evaluate the clinical efficacy of oral health education and a fluoride varnish in the prevention of caries in children. In this clinical study 300 children under the age of 3 with at least 4 erupted tooth, among local public health care centers in Shiraz were selected. The children randomly divided into three groups. 1) control; no preventive intervention; 2) oral health counseling; and 3) oral health counseling and fluoride varnish at baseline and six months later. Each group contained 100 children. This research was randomized, single blind with placebo control and the aim was prevention and reduction of dental caries in primary teeth.
A file according to the patient's demographic characteristics and the number of erupted teeth was formed for each child.Two dentistry interns cooperated on practical steps of the project and in evaluation periods in 4, 8 and 12 months after the base line. The caries index (dmft) was used to examine the teeth as primary outcome. Also the parents knowledge and performance regarding oral health in children in each group was assessed by using a questionnaire as secondary outcome. The outcome was the influences of each method in caries reduction in children.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201508127402N5
Registration date:2015-08-26, 1394/06/04
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-08-26, 1394/06/04
Registrant information
Name
Mahtab Memarpour
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1626 3192
Email address
memarpour@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences
Expected recruitment start date
2013-03-20, 1391/12/30
Expected recruitment end date
2014-03-20, 1392/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effectiveness of Fluoride Varnish and Oral Health Education on Prevention of Dental Caries in Primary teeth in Children under the Age of Three Years
Public title
Comparison of Fluoride Varnish and Oral Health Education on Prevention of Dental Caries in Primary teeth
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: children who were between 12 and 24 months of age at the beginning of the study; all participants had at least four erupted primary teeth and none of the teeth showed signs of non-cavitated or cavitated caries (dmft=0); the parents did not use any prevention of dental caries at home or in other clinics.
Exclusion criteria: medical histories of systemic diseases in children; drug allergies; congenital physical disabilities; mental disabilities; dental anomalies.
Age
From 1 year old to 3 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
300
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
Shiraz University of Medical Sciences
Street address
Shiraz University of Medical Sciences, Zand street
City
Shiraz
Postal code
00987112122389
Approval date
2013-09-23, 1392/07/01
Ethics committee reference number
Ct-p-92-6158
Health conditions studied
1
Description of health condition studied
dental caries
ICD-10 code
K02.0
ICD-10 code description
Caries limited to enamel
Primary outcomes
1
Description
dental caries reduction
Timepoint
4, 8 and 12 months after base line
Method of measurement
dmft index assess by dental examination with using dental mirrors and ball-ended probes
Secondary outcomes
1
Description
parents' knowledge toward oral health
Timepoint
4, 8 and 12 months after base line
Method of measurement
self reporting questionnaire
2
Description
parents' performance toward oral health
Timepoint
4, 8 and 12 months after base line
Method of measurement
self reporting questionnaire
Intervention groups
1
Description
group 1(control): The control group participants did not receive any oral health care intervention or treatment for caries prevention. The placebo was used similar to material used in group 3.
Category
Placebo
2
Description
group 2. Oral health counseling in each follow up times. The placebo was used similar to material used in group 3.
Category
Prevention
3
Description
group 3; fluoride varnish application in the base line and 6 months later. Oral hygiene counseling in each follow up times.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Public Health Care Centers in Shiraz (Valfajr,...)
Full name of responsible person
Mahtab Memarpour
Street address
Department of Pediatric Dentistry, School of Dentistry, Ghomabad
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr Postfroosh Fard
Street address
Shiraz University of Medical Sciences, Zand Street
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Mahtab Memarpour
Position
Professor, Department of Pediatric Dentistry
Other areas of specialty/work
Street address
Department of Pediatric Dentistry, School of Dentistry, Ghomabad, Ghasrodasht
City
Shiraz
Postal code
Phone
+98 71336270322
Fax
Email
memarpour@sums.a.cir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mahtab Memarpour
Position
Professor, Department of Pediatric Dentistry,
Other areas of specialty/work
Street address
Department of Pediatric Dentistry, School of Dentistry, Ghomabad, Ghasrodasht
City
Shiraz
Postal code
Phone
+98 71336270322
Fax
Email
memarpour@sums.sc.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mahtab Memarpour
Position
Professor, Department of Pediatric Dentistry
Other areas of specialty/work
Street address
Department of Pediatric Dentistry, School of Dentistry, Ghomabad, Ghasrodasht
City
Shiraz
Postal code
Phone
+98 71336270322
Fax
Email
memarpour@sums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)