Clinical comparaison of the retention of fissure sealant following preparation with seventh generation bonding agent with separate etch and preparation with etch and rinse(fifth generation
The objective of this study was clinical comparaison of the retention of fissure sealant following preparation with seventh generation bonding agent with separate etch and preparation with etch and rinse(fifth generation).
Design
The samples will be 40 individuals in the age group of 7-12 years randomly selected by randlist software, in which they have a pair of first permanent healthy molars without 2-sided mandibular molars decay with condition of fissure sealant therapy. Then, patients were non-randomly divided in two control and intervention groups. Clinical-trial phase is not exemplified in this study.
Settings and conduct
This clinical trial study on decay prevention will be done in Tabriz Dentistry Faculty.
the samples will be 40 individuals in the age group of 7-12 years . In each sample, a tooth will be treated by preparation method with a seventh-generation bonding method plus a separate etch and the same tooth in the opposite side will be treated with the usual preparation method (etching acid with bonding) with fifth generation of sealant.
Participants/Inclusion and exclusion criteria
Inclusion Criteria 1)7-12 years of age,2)presence of two first lower molars without caries, 3)deep groove that indicate fissure sealant therapy,4)satisfaction of parentes. Exclusion Criteria 1) carious molars, 2)if two molars were not in the same jaw
Intervention groups
Intervention group: fissure sealant therapy with Clearfil S3 Bond and separate etch in a molar tooth in one quadrant of the mandible
Control group: fissure sealant therapy with acid etch and bonding in the molar of the opposite side of the intervention group
Main outcome variables
Retention of fissure sealant
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171107037300N1
Registration date:2017-12-04, 1396/09/13
Registration timing:prospective
Last update:2017-12-04, 1396/09/13
Update count:0
Registration date
2017-12-04, 1396/09/13
Registrant information
Name
Azin Sohrabi
Name of organization / entity
Faculty of Dentistry
Country
Iran (Islamic Republic of)
Phone
+98 914 313 7523
Email address
sohrabia@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Research Vice-Chancellor, Tabriz University of Medical Sciences
Expected recruitment start date
2017-12-11, 1396/09/20
Expected recruitment end date
2017-12-21, 1396/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical comparaison of the retention of fissure sealant following preparation with seventh generation bonding agent with separate etch and preparation with etch and rinse(fifth generation
Public title
The clinical comparison of two methods for sealing fissures of young permanent teeth
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
7-12 years of age
presence of two first lower molars without caries
deep groove that indicate fissure sealant therapy
satisfaction of parentes
Exclusion criteria:
carious molars
if two molars were not in the same jaw
Age
From 7 years old to 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
More than 1 sample in each individual
Number of samples in each individual:
2
two intact first molars were in the lower jaw
Randomization (investigator's opinion)
Not 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
Research vice-chancellor,Tabriz University of Medical Sciences
Street address
Daneshgah Ave-Golgasht St.- Faculty of Dentistry-Department of Pediatric Dentistry
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Approval date
2017-10-16, 1396/07/24
Ethics committee reference number
IR.TBZMED.REC.1396.648
Health conditions studied
1
Description of health condition studied
clinical evaluation of two fissure sealant therapy methods
ICD-10 code
z01.2
ICD-10 code description
dental examination
Primary outcomes
1
Description
The retention of sealants
Timepoint
6 months
Method of measurement
exploration and observation
Secondary outcomes
1
Description
The working time
Timepoint
6 months
Method of measurement
exploration and observation
Intervention groups
1
Description
Intervention group:1)Isolation 2)Tooth cleaning 3)Using 37% acid etch(Etch Rite,PULPDENT Corporation U.S.A ) for 15 seconds 4)Rinse acid for 15 seconds 5)Use of bonding( Clearfil S3 Bond ,3M ESPE-PULPDENT Corporation U. S.A) on tooth surface and curing for 10 seconds 6)Use of sealant( Clinpro-3M, U.S.A) on tooth surface and curing for 20 seconds 7) evaluation of sealing groove and occlusion
Category
Prevention
2
Description
Control group: 1)Isolation 2)Tooth cleaning 3)Using 37% acid etch(Etch Rite,PULPDENT Corporation U.S.A ) for 15 seconds 4)Rinse acid for 15 seconds 5)Use of bonding( Single Bond2 ,3M ESPE-PULPDENT Corporation U. S.A) on tooth surface and curing for 10 seconds 6)Use of sealant( Clinpro-3M, U.S.A) on tooth surface and curing for 20 seconds 7) evaluation of sealing groove and occlusion
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Tabriz Faculty of Dentistry-Department of Pediatric Dentistry
Full name of responsible person
azin sohrabi
Street address
Daneshgah Ave- Golgasht St.-Tabriz Univdrsity of Medical Sciences-Faculty of Dentistry-Department of Pediatric Dentistry
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 5965
Fax
+98 41 3334 6977
Email
sohrabia@tbzmed.ac.ir
Web page address
http://dentistryfac.tbzmed.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mohammad samiee
Street address
Daneshgah Ave. - Golgasht St.-Tabriz University of Medical Sciences
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3334 0310
Fax
+98 41 3334 6977
Email
msamiee22@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Faculty of Dentistry
Full name of responsible person
Dr Azin sohrabi
Position
Asistant Proffessor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Daneshgah Ave-Golgasht St.- Faculty of Dentistry-Department of Pediatric Dentistry
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41333559659
Fax
+98 41 3334 6977
Email
sohrabia@tbzmed.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Faculty of Dentistry
Full name of responsible person
Dr Azin Sohrabi
Position
Pedodontist-Assistant Proffessor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Daneshgah Ave-Golgasht St-Tabriz University of Medical Sciences-Faculty of Dentistry
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41333559659
Fax
+98 41 3334 6977
Email
sohrabia@tbzmed.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Faculty of Dentistry
Full name of responsible person
Dr Azin Sohrabi
Position
Pedodontist-Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Tabriz Faculty of Dentistry-Department of Pediatric Dentistry
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41333559659
Fax
+98 41 3334 6977
Email
sohrabia@tbzmed.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available