Effectiveness of Fluoride Varnish in Remineralization of Incipient Carious Lesion during a 7-month period by means of paraclinical criteria (Diagnodent)
Objective: this study is designed to assess the effectiveness of fluoride varnish application every three months on incipient enamel lesions in compare to those who have not received this intervention. Methods: 208 tooth surfaces in 6-12 years of age children are divided randomly to case and control. The cases will receive fluoride varnish application at three month intervals. For the control group precise and individual oral hygiene instruction will be provided every three months and tooth brushes and dentifrices are also given to them at these visits. Evaluation of enamel lesion will be accomplished by Diagnodent after 7 months to evaluate the effects of this intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201110221861N3
Registration date:2012-01-27, 1390/11/07
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-01-27, 1390/11/07
Registrant information
Name
Katayoun Salem
Name of organization / entity
Tehran Azad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2258 0966
Email address
nastaranegar@gmail.com
Recruitment status
Recruitment complete
Funding source
Dental Research center of Guilan Dental School
Expected recruitment start date
2011-11-01, 1390/08/10
Expected recruitment end date
2012-06-01, 1391/03/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of Fluoride Varnish in Remineralization of Incipient Carious Lesion during a 7-month period by means of paraclinical criteria (Diagnodent)
Public title
Fluoride Varnish versus Oral Hygiene Instructions in Control of Incipient carious Lesions
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Discoloration or white opacities with explorer wedge in the fissures of first permanent molar. Exclusion Criteria: Any Hypoplastic defects on enamel surface.
Age
From 6 years old to 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
208
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
Deputy of Research, Guilan University of Medical Sciences
Street address
Namjoo Blvd
City
Rasht
Postal code
Approval date
2011-08-27, 1390/06/05
Ethics committee reference number
3900906603
Health conditions studied
1
Description of health condition studied
Incipient Enamel caries
ICD-10 code
K02.0
ICD-10 code description
Caries limited to enamel
Primary outcomes
1
Description
Dental caries
Timepoint
Every three monthys
Method of measurement
clinical examination (color, consistency, diameter) and Diagnodent (score)
Secondary outcomes
1
Description
Oral Hygiene
Timepoint
At the beginning and after completing the study
Method of measurement
Simplified Oral Hygiene Index
Intervention groups
1
Description
Interventional Group:At first the surface of first permanent molars are cleansed by the means of prophylaxis paste and rubber cup.Then the tooth surface is dried by a blast of air and isolated with cotton rolls. Fluoride varnish is applied as a thin layer all around the tooth surface and keep isolated for 15 seconds.The patients are instructed not to chew for 2 hours and avoid tooth brushing until the next day.
Category
Prevention
2
Description
Control group: Subjects in this group will receive face to face oral hygiene instructions individually including tooth brushing by scrub method ,flossing and dietary consultation.Prophylaxis will be repeated every three months and they also will receive free toothbrush and toothpaste every three months.
Final evaluation will take place at the end of 7 months.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Guilan Dental School and primary schools of the Rasht
Full name of responsible person
Dr Katayoun Salem
Street address
Opposite Pardis Hotel, Imam Blvd.
City
Rasht
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chnceller of Research and Technology, Guilan University of medical sciences
Full name of responsible person
Dr Rasool Tabari
Street address
Azodi Blvd.
City
Rasht
Grant name
بودجه مصوب معاونت فناوری
Grant code / Reference number
پ621/987
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chnceller of Research and Technology, Guilan 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
Guilan Dental school
Full name of responsible person
Dr Javaneh Vejdani
Position
Assistant Professor, Guilan Dental school
Other areas of specialty/work
Street address
Opposite Pardis Hotel, Imam blvd.
City
Rasht
Postal code
41817
Phone
+98 13 1322 0060
Fax
Email
jvejdani@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Dr Katayoun Salem
Position
Assistant Professor
Other areas of specialty/work
Street address
Opposite Pardis Hotel, Imam Blv.
City
Rasht
Postal code
41817
Phone
+98 13 1322 0060
Fax
Email
k_salem@gums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Department of Pediatric Dentistry, Gilan Dental School
Full name of responsible person
Katayoun Salem
Position
Assistant Professor
Other areas of specialty/work
Street address
Department of Pediatric Dentistry, Gilan Dental School, Opposite Pardis Hotel, Imam Blvd.
City
Rasht
Postal code
41817
Phone
+98 91313220060
Fax
Email
k_salem@gums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)