Comparison of clinical fitting and adjustment time for implant-supported crowns produced by conventional and digital workflow in partial edentulous patients
Comparison of clinical fitting and adjustment time for implant-supported crowns produced by conventional and digital workflow in partial edentulous patients
Design
Two arm parallel group randomised trial with blinded outcome assessment is performed. Thirty (30) patients are enrolled in the study. Patients are randomly divided into two groups.
Settings and conduct
Clinical trial is done at Mashhad Dental School.Treatment plan is done on two adjacent posterior implants. The crowns splinted to each other and adjusting is done on full Contour crowns. Adjusting time is recorded. The outcome assessor and data analyzer will kept blinded.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Two neighbor implants in premolar and molar sites with existing interproximal and antagonistic contacts;
Periodontal conditions of the patient should be healthy or successfully treated;
Patients' age should be at least 18 years old;
The distance between the two implants should be 3 mm and the distance between the implants and tooth should be at least 1.5 mm;
Maximum angle of the two implants should be 25 degrees.
Exclusion criteria:
smoker patients
Intervention groups
Intervention group: Digital impression is taked with oral scanner. The STL-data of virtual impression are sent to dental laboratory. Customized titanium abutments and full contour zirconia crowns are designed simultaneously and then are milled.
Control group: Impression taking of implants is done with open tray technique and silicone materials. Impressions are sent to dental laboratory. Casts are poured and then scanned with laboratory scanner. Customized titanium abutments and full contour zirconia crowns are designed simultaneously and then are milled.
Main outcome variables
Adjustment time of implant supported crown
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181216041993N1
Registration date:2019-03-30, 1398/01/10
Registration timing:retrospective
Last update:2019-03-30, 1398/01/10
Update count:0
Registration date
2019-03-30, 1398/01/10
Registrant information
Name
Ehsan Kiamanesh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3882 9501
Email address
kiamaneshe951@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-01-05, 1397/10/15
Expected recruitment end date
2019-02-20, 1397/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of clinical fitting and adjustment time for implant-supported crowns produced by conventional and digital workflow in partial edentulous patients
Public title
Effect of production method on the accuracy of implant-supported crowns
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Two neighbor implants in premolar and molar sites with existing interproximal and antagonistic contacts.
Periodontal conditions of the patient should be healthy or successfully treated
Being at the age of 18 years and over
The distance between the two implants is 3 mm and the distance between the implants and tooth is at least 1.5 mm
Maximum angle of the two implants should be 25 degrees
Exclusion criteria:
smoker patients
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Numbers 1 to 30 are placed inside the envelope. Patients randomly take a number from the envelope. The patients with odd numbers will be in the control group and the patients with even numbers will be in the intervention group.
Blinding (investigator's opinion)
Single blinded
Blinding description
After the abutments and crowns were prepared, They are delivered in the same package to the evaluator of the outcomes. Without knowledge of the patient group, He does the process of adjusting the crowns and Records the outcomes.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
Mashhad Dental School, in front of Mellat Park, Vakil Abad Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Approval date
2018-11-21, 1397/08/30
Ethics committee reference number
IR.MUMS.DENTISTRY.REC.1397.086
Health conditions studied
1
Description of health condition studied
Impression taking procedure of implants
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Adjustment time of implant supported crowns
Timepoint
At the time of try-in the crowns
Method of measurement
Digital timer
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Digital impression is taked with oral scanner. The STL-data of virtual impression are sent to dental laboratory. customized titanium abutments and full contour zirconia crowns are designed simultaneously and then are milled.
Category
Treatment - Other
2
Description
Control group: Impression taking of implants is done with open tray technique and silicone materials. Impressions are sent to dental laboratory. Casts are poured and then scanned with laboratory scanner. Customized titanium abutments and full contour zirconia crowns are designed simultaneously and then are milled.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Mashhad Dental School
Full name of responsible person
Ehsan Kiamanesh
Street address
Mashhad Dental School, in front of Mellat Park, Vakil Abad Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Phone
+98 51 3882 9501
Fax
Email
kiamaneshe951@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Mashhad Dental School, in front of Mellat Park, Vakil Abad Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
917751365
Phone
+98 51 3882 3255
Email
tafaghodim@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Ehsan kiamanesh
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Mashhad Dental School, in front of Mellat Park, Vakil Abad Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Phone
+98 51 3882 9501
Email
kiamaneshe951@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Hamid Reza Rajati haghi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Mashhad Dental School, in front of Mellat Park, Vakil Abad Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Phone
+98 51 3882 9501
Email
rajatihr@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Ehsan kiamanesh
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Mashhad Dental School, in front of Mellat Park, Vakil Abad Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Phone
+98 51 3882 9501
Email
kiamaneshe951@mums.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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data can be shared after making all data unidentifiable
When the data will become available and for how long
The access period starts one year after the results are printed
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
For use in scientific articles with mention of the source
From where data/document is obtainable
Ehsan Kiamanesh
Mashhad Dental School, in front of Mellat Park, Vakil Abad Blvd.
Postal code: 9177948959
phone: +985138829501
mobile : +989151591702
email: kiamaneshe951@mums.ac.ir
What processes are involved for a request to access data/document
Requests are received by email and will be answered after the evaluation.