Introduction: salivary contamination is the major cause of sealants' loss in the first year. Despite the resin base sealants being considered as the first choice in sealant therapy, recent advances in the production of glass-ionomers, these materials have been proposed as a viable option for sealant therapy. The aim of this study was to evaluate the 12 month clinical success rate of two types of resin and glass ionomer sealant.
Method : Samples for randomized clinical trial study consist of 40 children 6-10 years that meet inclusion criteria. 2 first molars in one jaw will be sealed randomly.one side with resin based sealant (HelioselF) and the other side with glass ionomer sealant (fuji triage).Sealants will be evaluated after 3, 6,9 and 12 months using modified Ryge criteria for retention, marginal adaptation, colour match, surface smoothness and caries.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013041611960N2
Registration date:2013-12-20, 1392/09/29
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-12-20, 1392/09/29
Registrant information
Name
Nasim Shafiezadeh
Name of organization / entity
Islamic Azad University, Dental branch
Country
Iran (Islamic Republic of)
Phone
+98 21 2256 4571
Email address
n_shafiezadeh@dentaliau.ac.ir
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2013-04-21, 1392/02/01
Expected recruitment end date
2014-04-22, 1393/02/02
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
One year clinical evaluation of glass ionomer and resin based fissure sealants on permanent first molars
Public title
Clinical evaluation of Glass Ionomer fissure sealants
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: children 6 to 10 from both sex whom are admitted in pediatric department of dental branch.They should have 2 first permanent fully erupted intact molars in one jaw without any previous treatment .They should be behaviorally manageable, without any systemic disorder or consuming any drug with saliva effect; at least dmft index =1 and Oleary index:10%.
Age
From 6 years old to 10 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
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
Dental Branch,Islamic Azad University
Street address
No5 ,Neyestan 10,Pasdaran Ave
City
Tehran
Postal code
19585/175
Approval date
2013-04-21, 1392/02/01
Ethics committee reference number
د/150/پ
Health conditions studied
1
Description of health condition studied
Dental caries prevention
ICD-10 code
Y56.7
ICD-10 code description
Dental drugs, topically applied
Primary outcomes
1
Description
Sealant retention
Timepoint
At months: 3, 6, 9 and 12
Method of measurement
Clinical examinatioin
2
Description
Marginal adaptation
Timepoint
At months: 3, 6, 9 and 12
Method of measurement
Clinical examination
3
Description
Color adjustment
Timepoint
At months: 3, 6, 9 and 12
Method of measurement
Clinical examination
4
Description
Surface smoothness
Timepoint
At months: 3, 6, 9 and 12
Method of measurement
Clinical examination
5
Description
Caries
Timepoint
At months: 3, 6, 9 and 12
Method of measurement
Clinical examination
Secondary outcomes
empty
Intervention groups
1
Description
In one jaw,one side permanent molar will be sealed with glass inomer material fissure salant: Fuji Triage triage (GC,Tokyo,Japan)(case group)
Category
Prevention
2
Description
The first permanent molar in the other side of the same jaw will be sealed with resin based material fissure sealant: Helioseal-F(ivoclar vivadent AG, schoan, Liechtenstein) (control group)
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Dental Branch, Islamic Azad University
Full name of responsible person
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Dental Branch, Islamic Azad University
Full name of responsible person
Dr Marjan Azarshab
Street address
No 5, Neyestan 10, Pasdaran Ave
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Dental Branch, Islamic Azad University
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
Dental Branch, Islamic Azad University
Full name of responsible person
Dr Nasim Shafiezadeh
Position
Assisstant Professor/Pedodontist
Other areas of specialty/work
Street address
No5, Neyestan10, Pasdaran Ave
City
Tehran
Postal code
Phone
+98 21 2256 4571
Fax
Email
shafizad@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Dental branch, Islamic Azad University
Full name of responsible person
Dr Nasim Shafiezadeh
Position
Assisstant Professor/Pedodontist
Other areas of specialty/work
Street address
No 5,Neyestan10,Pasdaran Ave
City
Tehran
Postal code
Phone
+98 21 2256 4571
Fax
Email
n_shafiezadeh@dentaliau.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
ِDental branch,Islamic Azad Univerity
Full name of responsible person
Dr Nasim Shafiezadeh
Position
Assistant Professor
Other areas of specialty/work
Street address
Pasdaran,Niestan 10,No5
City
Tehran
Postal code
Phone
+98 21 2256 4571
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)