The aim of this study is to compare clinical success of applying a fissure sealant (smart seal & loc) on the lower permanent molar teeth in dry and wet conditions. In this study, 31 children, aged 6-12 years old, who have one first or second fully erupted permanent molar in each side of mandible will be recruited. These teeth must have the indication of fissure sealant therapy. One side will be treated with conventional method and the other side will be treated with new method (sealant therapy with a hydrophlic fissure sealant in wet condition). Clinical success on permanent molars will be compared between groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138904124293N1
Registration date:2010-12-12, 1389/09/21
Registration timing:retrospective
Last update:
Update count:0
Registration date
2010-12-12, 1389/09/21
Registrant information
Name
Saied Baghi
Name of organization / entity
Shiraz Dental School
Country
Iran (Islamic Republic of)
Phone
+98 71 1626 3192
Email address
baghis@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellery of Research Affairs, Shiraz University of Medical Sciences and Health Services
Expected recruitment start date
2009-09-23, 1388/07/01
Expected recruitment end date
2010-04-21, 1389/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of clinical success of applying a fissure sealant (smart seal & loc) on the lower permanent molar teeth in dry and wet conditions.
Public title
Comparison of clinical success of applying a fissure sealant (smart seal & loc) on the lower permanent molar teeth in dry and wet conditions.
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: age 6-12, having one first or second erupted molar in each side of lower jaw, having complicated fissures, no any sign of caries, being at low risk of dental caries, the parent have cooperation for recall visits
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:
31
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shiraz University of Medical Sciences and Health Services
Street address
Head office of Shiraz University of Medical Sciences and Health Services, Zand street
City
Shiraz
Postal code
Approval date
2010-06-23, 1389/04/02
Ethics committee reference number
CT-89-5113
Health conditions studied
1
Description of health condition studied
prevention of dental caries
ICD-10 code
K02.9
ICD-10 code description
Dental caries, unspecified
Primary outcomes
1
Description
Clinical success
Timepoint
Before intervention, 6 and 12 months after intervention
Method of measurement
Feigal standard form-by two idipendent observer
Secondary outcomes
1
Description
Dental caries
Timepoint
6 and 12 months after intervention
Method of measurement
Feigal standard form-by two independent observer
Intervention groups
1
Description
Fissure sealant therapy by a hydrophil fissure selant with conventional method
Category
Prevention
2
Description
Fissure sealant therapy by a hydrophil fissure selant with new method (in wet condition)
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Pedodontics department, Shiraz Dental School
Full name of responsible person
Dr. Saied Baghi
Street address
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellery of Research Affairs Shiraz University of Medical Sciences and Health Services
Full name of responsible person
Dr. Dabagh manesh
Street address
Head office of Shiraz University of Medical Sciences and Health Services, Zand st.
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-chancellery of Research Affairs Shiraz University of Medical Sciences and Health Services
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
Pedodontics department, Shiraz dental school
Full name of responsible person
Dr. Saied Baghi
Position
Resident
Other areas of specialty/work
Street address
Shiraz Dental School, Ghasr dasht st.
City
Shiraz
Postal code
Phone
+98 71 1626 3193
Fax
Email
baghis@sums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Pedodontics department, Shiraz Dental School
Full name of responsible person
Dr. Tahere Eskandarian
Position
Assistant professor/ Pedodontist
Other areas of specialty/work
Street address
Shiraz Dental School, Ghasr dasht st.
City
Shiraz
Postal code
Phone
+98 71 1627 3193
Fax
Email
teskandary@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Full name of responsible person
Dr. Saied Baghi
Position
Other areas of specialty/work
Street address
City
Postal code
Phone
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)