Effect of aluminum chloride as a hemostatic agent on shear bond strength of two step self etch and universal bonding agents used on extracted human teeth
Objectives: Bond strength of the composite restorations is one of the important factors to achieve success in restoring teeth. This in vitro study evaluated the effect of a hemostatic agent on shear bond strength of a two step self etch and a Universal bonding agents.
Design: This study is an double blind study. Forty extracted human premolars without any caries, cracks and restorations were selected.
Setting and conduct: After disinfection process with Thymol solution, specimens were kept in distilled water until the beginning of the test procedures. The mesial or distal dentin surfaces were exposed and polished for the same time to gain similar smear layers. They randomly assigned to four groups as follows: (n=10)
A: ViscoStat Clear and All Bond SE
B: ViscoStat Clear and All Bond Universal
C: All Bond SE
D: All Bond Universal.
The information was kept with a person who did not play a roll in the bond strength test.
ViscoStat Clear was applied according to manufacturer’s instructions. Then it was rinsed with constant pressure and the rinsing time was as long as the application time. Composite cylinders were incrementally cured on the dentine surfaces. After 1000 rounds of thermocycling (5 to 55 °C with a dwell time of 30 seconds and a transfer time of 30 seconds), shear bond strength test was performed.
Intervention: Aluminum chloride as a hemostatic agent (ViscoStat Clear)
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017101136711N1
Registration date:2017-11-13, 1396/08/22
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-11-13, 1396/08/22
Registrant information
Name
Keyvan Saati
Name of organization / entity
Islamic Azad University of Medical Sciences, Dental Branch, Tehran
Country
Iran (Islamic Republic of)
Phone
+98 21 2258 0925
Email address
k_saati@dentaliau.ac.ir
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2017-11-22, 1396/09/01
Expected recruitment end date
2017-12-22, 1396/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of aluminum chloride as a hemostatic agent on shear bond strength of two step self etch and universal bonding agents used on extracted human teeth
Public title
Effect of an anti bleeding substance on durability of the composite restorations
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: human extracted premolar; teeth with approximately the same size
Exclusion criteria: caries; cracks; restorations
Age
No age limit
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)
Double blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
This study is not a clinical trial one. It is an in vitro study. The study is done on the extracted human teeth. In our country, it is not necessary to get ethics committee code for extracted teeth. Now we want to submit this study to a journal of another country. In the author's instructions, it is written that ethics committee code is necessary even for the extracted teeth. As a result, we are proceeding to get this code.
According to Iranian Registry Clinical Trial organization's laws, the date of the recruitment should be specified. Whereas the current study has been done on extracted human teeth and it has completed. The teeth were collected in the year 2016. Since this date has passed, it is not approved by the mentioned organization. Therefore the specified date is actually after the completion of the study.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Islamic Azad University of Medical Sciences, Dental Branch
Street address
Neyestan 9 Ave. Pasdaran St. Tehran
City
Tehran
Postal code
19585175
Approval date
2017-09-24, 1396/07/02
Ethics committee reference number
IR.IAU.DENTAL.REC.1396,24
Health conditions studied
1
Description of health condition studied
Relationship between the aluminum chloride as a hemostatic agent and shear bond strength of a two step self etching and universal bonding agents
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Shear bond strength
Timepoint
24 h
Method of measurement
Universal Testing Machine
Secondary outcomes
empty
Intervention groups
1
Description
Aluminum chloride as a hemostatic agent according to manufacturer's instructions (test group)
Category
Prevention
2
Description
without hemostatic agent (control group)
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Islamic Azad University of Medical Sciences, Dental Branch
Full name of responsible person
Keyvan Saati
Street address
Islamic Azad University, Dental Branch, Neyestan 9 Ave. Pasdaran St.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Investigator
Full name of responsible person
Investigator
Street address
-
City
Tehran
Grant name
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Investigator
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
Islamic Azad University of Medical Sciences, Dental Branch, Tehran
Full name of responsible person
Keyvan Saati
Position
DDS, MS Assistant Professor
Other areas of specialty/work
Street address
Neyestan 9 Ave. Pasdaran St. Tehran, Iran
City
Tehran
Postal code
19585175
Phone
+98 21 2258 0925
Fax
+98 21 2276 3432
Email
keivan.saati@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University of Medical Sciences, Dental Branch, Tehran
Full name of responsible person
Keyvan Saati
Position
DDS, MS Assistant Professor
Other areas of specialty/work
Street address
Neyestan 9 Ave. Pasdaran St. Tehran
City
Tehran
Postal code
19585175
Phone
+98 21 2258 0925
Fax
+98 21 2276 3432
Email
keivan.saati@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University of Medical Sciences, Dental Branch, Tehran
Full name of responsible person
Bahar Bonakdar
Position
Student
Other areas of specialty/work
Street address
Neyestan 9 Ave. Pasdaran St. Tehran
City
Tehran
Postal code
19585175
Phone
00
Fax
+98 21 2276 3432
Email
bahar.bnk@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)