to compare the clinical success of a new hydrophilic resin-based fissure sealant (Embrce Wet Bond) and a conventional hydrophobic resin-based fissure sealant ( Helioseal F) , Fourty children (6 to 9 year old) reffered to pediatric ward of tehran azad university of dentistry randomized to 2 subgroups: Embrace fissure sealant (Pulpdent) or Helioseal. For each group Surfaces were cleaned and dried, then etched for 15 seconds. Excess water was removed leaving the surface slightly moist. Sealant was applied from cusp to cusp without covering marginal ridges and light cured for 20 seconds using a LED light.Patients will be evaluated after 3,6,12,18 months for the following criteria' : any avidence of caries, marginal adaptation, surface smoothness and retention
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014072618601N1
Registration date:2015-02-08, 1393/11/19
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-02-08, 1393/11/19
Registrant information
Name
Nazanin Zangeneh
Name of organization / entity
Islamic Azad University
Country
Iran (Islamic Republic of)
Phone
+98 21 4421 0303
Email address
den_zangeneh@yahoo.com
Recruitment status
Recruitment complete
Funding source
Islamic Azad University of Tehran
Expected recruitment start date
2014-09-23, 1393/07/01
Expected recruitment end date
2016-04-20, 1395/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
comparison of clinical success of Embrace fissure sealant whit Helioseal
Public title
the evaluation of clinical success of a hydrophilic fissure sealant
Purpose
Prevention
Inclusion/Exclusion criteria
6 to 9 year old children reffered to pediatric ward of tehran azad university of dentistry who have following criteria include:the presence of tow fully erupted first permanent molars in both sides of the jaw; havig a acceptable hygine training plan; compliant patient during treatment and follow ups; lack of caries and anomalies; lack of hypocalcification,lack of privious treatment on the first molars; possibility of acceptable isolation; lack of medical hisory or any drug effective on saliva flow; lack of allergy to restorative materials
Age
From 6 years old to 9 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran Azad University of Dentistry
Street address
10th neyestan, Pasdaran
City
Tehran
Postal code
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
11-ت
Health conditions studied
1
Description of health condition studied
Dental caries
ICD-10 code
K02.9
ICD-10 code description
Dental caries, unspecified
Primary outcomes
1
Description
retention
Timepoint
3,6,12,18 month
Method of measurement
with explorer and visual
2
Description
marginal adaptation
Timepoint
3,6,12,18 month
Method of measurement
with explorer and visual
3
Description
caries
Timepoint
3,6,12,18 month
Method of measurement
with explorer and visual
4
Description
surface smoothness
Timepoint
3,6,12,18 month
Method of measurement
with explorer and visual
5
Description
colour match
Timepoint
3,6,12,18 month
Method of measurement
with explorer and visual
Secondary outcomes
empty
Intervention groups
1
Description
Surfaces were cleaned and dried, then etched for 15 seconds. Excess water was removed leaving the surface slightly moist. embrace Sealant was applied from cusp to cusp without covering marginal ridges and light cured for 20 seconds using a LED light
Category
Prevention
2
Description
Surfaces were cleaned and dried, then etched for 15 seconds. Excess water was removed leaving the surface slightly moist. Heliosea Sealant was applied from cusp to cusp without covering marginal ridges and light cured for 20 seconds using a LED light
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Pediatric Department of Tehran Azad University of Dentistry
Full name of responsible person
Nazanin Zangeneh
Street address
10th neyestan, Pasdaran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran Azad University of Dentistry
Full name of responsible person
Arash Azizi
Street address
10th neyestan,Pasdaran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran Azad University of Dentistry
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
Tehran Azad University of Dentistry
Full name of responsible person
Nazanin Zangeneh
Position
pediatric resident of Tehran Azad University of Dentistry
Other areas of specialty/work
Street address
10th neyestan, Pasdaran
City
Tehran
Postal code
Phone
+98 21 4421 0303
Fax
Email
den_zangeneh@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran Azad University of Dentistry
Full name of responsible person
Nazanin Zangeneh
Position
pediatric resident of Tehran Azad University of Dentistry
Other areas of specialty/work
Street address
10th neyestan, Pasdaran
City
Tehran
Postal code
Phone
+98 21 4421 0303
Fax
Email
den_zangeneh@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran Azad University of Dentistry
Full name of responsible person
Nazanin Zangeneh
Position
pediatric resident of Tehran Azad University of Dentistry
Other areas of specialty/work
Street address
10th neyestan, Pasdaran
City
Tehran
Postal code
Phone
+98 21 4421 0303
Fax
Email
den_zangeneh@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)