Objectives: Comparison of pit and fissure sealant retention following alumina or bio active glass air abrasion preparation. Design: Randomized, Single blind, No placebo control. Setting and conduct: Students aged 6 to 12 with 90 pairs of molars are include in study. Using a half-mouth design, the operator perform fissure preparation using BAG or alumina air abrasion technique on randomly assign mandibular or/ and maxillary first permanent molars. Operator applies sealant. Participants including criteria: Students aged 6 to 12 with 90 pairs of molars are include in study. Intervention: Using a half-mouth design, the operator perform fissure preparation using BAG air abrasion technique on randomly assign mandibular or/ and maxillary first permanent molars from one side of the mouth (Intervention group) and perform alumina air abrasion on the contra lateral side of the mouth (Control Group). Main outcome measures: The status of sealant retention are score as completely missing, partially Retention, Completely Retention by visual clinical assessment evaluation by simonsen criteria after 3, 6, 9, 12. month.
General information
Acronym
No
IRCT registration information
IRCT registration number:IRCT2014060117934N1
Registration date:2014-10-27, 1393/08/05
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-10-27, 1393/08/05
Registrant information
Name
Fatemeh Naderi Beni
Name of organization / entity
Isfahan Medical School
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 2891
Email address
fatemehnaderi@dnt.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Dr Mohammad Hashemi, Vice chancellor for research, Isfahan University of Medical Science.
Address: Hezar jerib St
Email: a_hashemi@med.mui.ac.ir
Tell: 00983137923061
Expected recruitment start date
2014-09-23, 1393/07/01
Expected recruitment end date
2014-10-22, 1393/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of pit and fissure sealant retention following alumina or bioactive glass air abrasion preparation
Public title
Comparison of pit and fissure sealant retention following bioactive glass air abrasion
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Subjects who their first permanent molars have no restorations or sealants on their fissures; no detectable caries met the inclusion criteria.
Exclusion criteria: Previously sealed first permanent molars; the ones with detectable dentin caries or fillings initially were excluded from the study.
Age
From 6 years old to 12 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
180
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
no
Secondary Ids
1
Registry name
-
Secondary trial Id
-
Registration date
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Isfahan Medical University
Street address
Hezar- jerib St
City
Isfahan
Postal code
-
Approval date
2013-12-09, 1392/09/18
Ethics committee reference number
393121
Health conditions studied
1
Description of health condition studied
No
ICD-10 code
-
ICD-10 code description
-
Primary outcomes
1
Description
Sealant Retention
Timepoint
At 3, 6, 9, 12 months after intervention
Method of measurement
Clinical examination with mirror and exploration probe
Secondary outcomes
1
Description
No
Timepoint
-
Method of measurement
-
Intervention groups
1
Description
Control group: Using of alumina air abrasion for the preparation of first permanent molar grooves.
Alumina is aluminum oxide. Using 50 micro meter particles for 15 seconds.
Category
Prevention
2
Description
Intervention group: Using of Bio-active glass air abrasion for 15 second. Bio-active glass particles is 50 micro meter.
Bio-active glass reacts with an aqueous solution where chemical and structural changes occur that result in the formation of a hydroxycarbonate apatite (HCA) surface layer an eventual dissolution of the powder particle. Bio-active glass is used currently in the oral cavity as bone-graft material.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
School of Dental Medicine
Full name of responsible person
Dr Alireza Eshghi
Street address
Hezar jerib St.
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Isfahan Univercity of Medical Sciences
Full name of responsible person
Dr Mohammad Hashemi
Street address
Hezar jerib St.
City
Isfahan
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Isfahan Univercity 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
Isfahan Dental Medical School
Full name of responsible person
Dr Alireza Eshghi
Position
Professor in the Department of Pediatric Dentistry; Professional Doctor of Pediatric Dentistry
Other areas of specialty/work
Street address
Hezar jerib St.
City
Isfahan
Postal code
-
Phone
+98 31 3792 2891
Fax
-
Email
eshghi@dnt.mui.ac.ir
Web page address
-
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan Dental Medical School
Full name of responsible person
Dr Alireza Eshghi; Dr Maryam KHoroushi
Position
Professional Doctor of Pediatric Dentistry; professional Doctor of Cosmetic and Restorative Dentistr
Other areas of specialty/work
Street address
Hezar jerib St.
City
Isfahan
Postal code
-
Phone
+98 37922891
Fax
-
Email
eshghi@dnt.mui.ac.ir; khoroushi@dnt.mui.ac.ir
Web page address
-
Person responsible for updating data
Contact
Name of organization / entity
Naderi Beni
Full name of responsible person
Fatemeh
Position
General Dentist; Assistant Professor of Pediatric Dentistry
Other areas of specialty/work
Street address
Hezar jerib st.
City
Isfahan
Postal code
-
Phone
+98 31 3792 2891
Fax
-
Email
fn3722212@yahoo.com
Web page address
-
Sharing plan
Deidentified Individual Participant Data Set (IPD)