Shear bond strength of brackets and enamel demineralization around brackets bonded with self etching primers compared to conventional acid etch technique: An in-vivo study
The aim of this study is to compare the effect of conventional acid etch technique and self etching primers on shear bond strength and demineralization around brackets. The statistical population comprises of patients referring to Hamadan dental school and private office of Doctor Farhadian for fixed orthodontic treatment. Twenty five patients with no craniofacial anomaly and systemic disease who require at least two sound intact premolar extraction are selected as the sample size. The orthodontic brackets are bonded randomly with conventional Acid etch technique (Controls) on one side and with Self Etching Primer (Experimental group) on the opposite side. A vertical loop formed with a 0.014 inch Stainless Steel wire is tied in the brackets with elastomeric module to help accumulate plaque. The teeth having the mentioned brackets are extracted at least 8 to 9 weeks later. Then, shear bond strength of brackets and demineralization around brackets are registered as the primary outcomes.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201705099086N3
Registration date:2017-07-07, 1396/04/16
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-07-07, 1396/04/16
Registrant information
Name
Nasrin Farhadian
Name of organization / entity
Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1835 4017
Email address
farhadian@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Deputy of Research and Technology, Hamadan University of Medical Sciences
Expected recruitment start date
2017-07-08, 1396/04/17
Expected recruitment end date
2017-11-08, 1396/08/17
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Shear bond strength of brackets and enamel demineralization around brackets bonded with self etching primers compared to conventional acid etch technique: An in-vivo study
Public title
Comparison of the effect of type of orthodontic bracket adhesive on dental caries around brackets and bond strength
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Patients requiring fixed orthodontic treatment for upper and/or lower arch; Treatment plan based on at least 2 premolar extraction; No previous orthodontic treatment; Sound and intact enamel on the buccal area; No restoration, attrition, and caries on enamel
Exclusion criteria: Craniofacial anomalies; Hypoplasia and obvious demineralization of enamel; Systemic diseases
Age
From 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
25
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
committee of ethics in research
Street address
Hamadan University of Medical Sciences
City
Hamadan
Postal code
Approval date
2017-05-27, 1396/03/06
Ethics committee reference number
IR.UMSHA.REC.1396.166
Health conditions studied
1
Description of health condition studied
Dental caries
ICD-10 code
K02.0
ICD-10 code description
Caries limited to enamel
Primary outcomes
1
Description
Enamel demineralization around brackets
Timepoint
8-9 weeks after treatment
Method of measurement
Lesion depth in microns by polarized light microscopy
2
Description
Shear Bond Strength
Timepoint
8-9 weeks after treatment
Method of measurement
pressure in megapascal by Instron unversal testing machine
Secondary outcomes
1
Description
Adhesive Remnant Index
Timepoint
8-9 weeks after treatment
Method of measurement
stereomicroscope with magnification by 60 times
Intervention groups
1
Description
Intervention: This group will receive Self Etching Primer for bonding brackets and after at least two months, the teeth were examined for demineralization and shear bond strength.
Category
Prevention
2
Description
Control: This group will receive conventional Acid Etch technique for bonding brackets and after at least two months, the teeth were examined for demineralization and shear bond strength the same as the intervention group.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Department of Orthodontics, Dental School, Hamadan University of Medical Sciences
Full name of responsible person
Street address
City
Hamadan
2
Recruitment center
Name of recruitment center
Office of Dr. Nasrin Farhadian
Full name of responsible person
Street address
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Deputy of Research and Technology, Hamadan University of Medical Sciences
Full name of responsible person
Saeid Bashirian
Street address
Shahid Fahmideh Street
City
Hamadan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy of Research and Technology, Hamadan University 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
Department of Orthodontics, Dental School, Hamadan University of Medical Sciences
Full name of responsible person
Vahid Shahidi Zandi
Position
DDS
Other areas of specialty/work
Street address
Shahid Fahmideh Street
City
Hamadan
Postal code
6517838677
Phone
+98 81 3838 1059
Fax
Email
vahidshahidi13@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Department of Orthodontics, Dental School, Hamadan University of Medical Sciences
Full name of responsible person
Nasrin Farhadian
Position
DDS, MSc, Orthodontist
Other areas of specialty/work
Street address
Shahid Fahmideh Street
City
Hamadan
Postal code
6517838677
Phone
+98 81 3838 1059
Fax
Email
nasrinfarhadian@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Department of Orthodontics, Dental School, Hamadan University of Medical Sciences
Full name of responsible person
Vahid Shahidi Zandi
Position
DDS
Other areas of specialty/work
Street address
Shahid Fahmideh Street
City
Hamadan
Postal code
6517838677
Phone
+98 81 3838 1059
Fax
Email
vahidshahidi13@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)