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Clinical evaluation of marginal fit of monolithic zirconia FDP, using scan able and conventional polyvinyl siloxane impression materials

Protocol summary

Study aim
Determining the most accurate molding method for use in prosthetic work
Design
clinical trial, control group, parallel groups
Settings and conduct
Among the patients referred to the dentures department of Shiraz Dental School, 10 people will be selected for lateral tooth replacement.
Participants/Inclusion and exclusion criteria
Patients who have lost their lateral teeth The patient should not be a deep bite The patient should have sufficient crown length
Intervention groups
Because the type of molding impressions and the method used in making prostheses and its marginal accuracy are of great importance, the purpose of this in-vivo study is to evaluate the marginal fit using conventional and scanable poly-vinyl siloxane impression materials, Then the accuracy of these two impression materials in recording the margin area will compare.
Main outcome variables
clinical evaluation of marginal fit

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20201011048994N1
Registration date: 2021-01-26, 1399/11/07
Registration timing: registered_while_recruiting

Last update: 2021-01-26, 1399/11/07
Update count: 0
Registration date
2021-01-26, 1399/11/07
Registrant information
Name
benika abbasi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3625 2335
Email address
abbasi_b@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-10-18, 1399/07/27
Expected recruitment end date
2021-03-10, 1399/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical evaluation of marginal fit of monolithic zirconia FDP, using scan able and conventional polyvinyl siloxane impression materials
Public title
marginal fit of monolithic zirconia FPD
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria:
All people who need a 3-unit bridge to replace a lateral tooth
Exclusion criteria:
All people who do not have lateral teeth The abutments have sufficient crown length
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 10
More than 1 sample in each individual
Number of samples in each individual: 2
From the prepared teeth of every 10 people take impression as the first group by the one-step putty-wash technique, which according to the manufacturer's instructions, first mixes two putty poly-vinyl siloxane scan capable pastes and puts them inside. Then light material is injected by guns on it and a tray is placed in the mouth and sufficient pressure is applied until the final set and the resulting molds are scanned by a scanner (3ShapeD810; 3Shape) SD laser scanned.Due to the properties of the molding material, there is no need to use spray when scanning. For the second group, again out of every 10 people in the same session, a mold is taken with putty poly-vinyl siloxane conventional material and then light material is taken on it with the same steps as with added silicone material (Panasil putty soft and initial contact light, Kettenbach , Eschenburg, Germany) is used. And then its gypsum cast is poured by Stone Dye Type IV gypsum. (GC Fujirock, GC corporation, leuven, Belgium). In the molds of the second group, in order for the surfaces of these dies to be able to be scanned, they are sprayed with a scan. These dies are also scanned by (3ShapeD810; 3Shape) SD laser scanned. The data obtained from both groups is converted to CAD data (3Shape CAD Design software; 3Shape).
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Shiraz, Qasrdasht St., Corner of Mehr St., Shiraz Dental School, First floor, Fixed Prosthesis Ward
City
Shiraz
Province
Fars
Postal code
۱۵۸۷۸- ۷۱۹۵۶
Approval date
2020-12-27, 1399/10/07
Ethics committee reference number
IR.SUMS.DENTAL.REC.1399.174

Health conditions studied

1

Description of health condition studied
clinical evaluation of marginal fit
ICD-10 code
-
ICD-10 code description
-

Primary outcomes

1

Description
Percentage of molding material error
Timepoint
End of treatment when prosthesis is delivered
Method of measurement
The replica is made and then the thickness of the silicon outer layer is measured with a microscope at 230X magnification (AM413FIT Dino-Lite Pro; Dino-Lite Electronic Corp. and image analysis software (DinoCapture 2.0; AnMo Electronics Corp.). Shows the marginal fit.

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: From 10 prepared teeth, a mold is prepared by a one-step putty-wash technique. According to the manufacturer's instructions, first two putty poly-vinyl siloxane scan capable pastes are mixed and placed inside, and then the light material by The gun is injected into it and a tray is placed in the mouth and sufficient pressure is applied until the final set and the resulting molds are scanned by a scanner (3ShapeD810; 3Shape) SD laser scanned. Control group: For every 10 people in the same session, a mold is taken with putty poly-vinyl siloxane conventional material and then light material is taken on it with the same steps as with added silicone material (Panasil putty soft and initial contact light, Kettenbach, Eschenburg, Germany ) Is used. And then its gypsum cast is poured by Stone Dye Type IV gypsum. (GC Fujirock, GC corporation, leuven, Belgium). In the molds of the second group, in order for the surfaces of these dies to be able to be scanned, they are sprayed by scanning spray
Category
Diagnosis

Recruitment centers

1

Recruitment center
Name of recruitment center
Department of Prosthodontics, Shiraz Dental School
Full name of responsible person
mohammad hasan kalantari
Street address
Department of Prosthodontics, Shiraz Dental School
City
shiraz
Province
Fars
Postal code
۱۵۸۷۸- ۷۱۹۵۶
Phone
+98 71 3626 3193
Email
kalantarim@sums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mohammad Hasan Kalantari
Street address
Shiraz, Qasrdasht St., Corner of Mehr St., Shiraz Dental School, First floor, Fixed Prosthesis Ward
City
Shiraz
Province
Fars
Postal code
۱۵۸۷۸- ۷۱۹۵۶
Phone
+98 71 3626 3193
Email
dental@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Mohammad Hasan Kalantari
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Shiraz, Qasrdasht St., Corner of Mehr St., Shiraz Dental School, First floor, Fixed Prosthesis Ward
City
Shiraz
Province
Fars
Postal code
۱۵۸۷۸- ۷۱۹۵۶
Phone
+98 71 3626 3193
Email
kalantarim@sums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mohammad Hasan Kalantari
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Shiraz, Qasrdasht St., Corner of Mehr St., Shiraz Dental School, First floor, Fixed Prosthesis Ward
City
Shiraz
Province
Fars
Postal code
۱۵۸۷۸- ۷۱۹۵۶
Phone
+98 71 3626 3193
Email
kalantarim@sums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Benika Abbasi
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Shiraz, Qasrdasht St., Corner of Mehr St., Shiraz Dental School, First floor, Fixed Prosthesis Ward
City
Shiraz
Province
Fars
Postal code
۱۵۸۷۸- ۷۱۹۵۶
Phone
+98 71 3626 3193
Email
abbasi_b@sums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
All data is potentially shareable after unidentified individuals
When the data will become available and for how long
Access period starts 6 months after the results are published
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
There are no special conditions
From where data/document is obtainable
abbasi_b@sums.ac.ir
What processes are involved for a request to access data/document
After reviewing the application and the reasons provided by the applicant, the data files will be sent as a PDF file via email.
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