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A comparative evaluation of clinical outcome of fully digital and conventional workflow in three-unit implant supported restorations: a clinical trial

Protocol summary

Study aim
The aim of this study is to evaluate the accuracy of impressions, the fitness and passivity of the frameworks, the occlusions, cost and time for building restorations in digital workflow and conventional workflow
Design
10 patients, cross over study
Settings and conduct
The patients who received two bone level implants( Dentium company) in faculty of dentistry of Tehran university of medical science or in implants research center were added in the study. they implants are in the posterior of the mandible and they need 3 units restorations after healing time. the accuracy of the impressions, the passivity and fitness of frameworks, the occlusion, aesthetic, time and cost of two restorations are evaluated.
Participants/Inclusion and exclusion criteria
Patients who received two implants (dentium company) and need 3 units restorations, the depth of implants lower than 5 mm from gingiva, the degree between two implants lower than 10, the inter occlusal space lower than 15 mm.
Intervention groups
Conventional impression, Conventional framework, Digital impression, Digital framework
Main outcome variables
Accuracy of impressions, passivity, accuracy, aesthetic, occlusion, cost, time

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20191009045041N1
Registration date: 2019-12-16, 1398/09/25
Registration timing: prospective

Last update: 2019-12-16, 1398/09/25
Update count: 0
Registration date
2019-12-16, 1398/09/25
Registrant information
Name
Ali Mahmoud Hashemi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2645 5649
Email address
a-mahmoudhashemi@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-12-21, 1398/09/30
Expected recruitment end date
2021-03-19, 1399/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparative evaluation of clinical outcome of fully digital and conventional workflow in three-unit implant supported restorations: a clinical trial
Public title
An evaluation of outcome of two workflow in multi unit implant supported restoration
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients received 2 bone level implants (dentium company) and need 3 units restorations Implants depth lower than 5 mm from gingiva The degree between two implants are lower than 10
Exclusion criteria:
Patients received 1 bone level implants (dentium company) and need 1 unit restoration Implants depth more than 5 mm from gingiva The degree between two implants are more than 10
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
Two restorations for all patients
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features
For all patients two restorations are built and patients received the better restoration and the other will give them for free.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Science
Street address
No. 1, Porsina St., Qods St., Enghelab Blvd
City
Tehran
Province
Tehran
Postal code
1467664961
Approval date
2019-12-07, 1398/09/16
Ethics committee reference number
IR.TUMS.VCR.REC.1398.673

Health conditions studied

1

Description of health condition studied
Implant supported restorations
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
accuracy of impressions ( changes in x,y,z axis)
Timepoint
after impression
Method of measurement
best fit algorithm

Secondary outcomes

1

Description
fitness
Timepoint
after framework
Method of measurement
radiography

2

Description
passivity
Timepoint
after framework
Method of measurement
auto cad

3

Description
occlusion
Timepoint
after restoration
Method of measurement
auto cad

4

Description
aesthetic
Timepoint
after restoration
Method of measurement
VAS

5

Description
time
Timepoint
whole time
Method of measurement
study

6

Description
cost
Timepoint
whole cost
Method of measurement
study

Intervention groups

1

Description
Intervention group: digital impression, seating scan body and then making impression with intraoral scanner in one session.
Category
Treatment - Other

2

Description
Intervention group: digital framework, milling the restorations with cad cam by private laboratory.
Category
Treatment - Other

3

Description
Control group: conventional impression, with special tray and poly-vinyl siloxane in one session.
Category
Treatment - Other

4

Description
Control group: conventional framework, chrome cobalt casting for making frameworks by private laboratory.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Faculty of dentistry, Tehran university of medical science
Full name of responsible person
Mr Reza Saboohi
Street address
North kargar Ave
City
Tehran
Province
Tehran
Postal code
1439955991
Phone
+98 21 8801 5950
Email
dentistry@tums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Marzieh Alikhasi (Vice chancellor, Dentistry faculty)
Street address
North kargar Ave
City
Tehran
Province
Tehran
Postal code
1439955991
Phone
+98 21 8801 5950
Email
dentistry@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Ali Mahmoud Hashemi
Position
PHD Candidate
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
No. 43, Saide ST, Niavaran Ave
City
Tehran
Province
Tehran
Postal code
1954811954
Phone
+98 21 2645 5649
Email
ali.mh.qq@gamil.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Marzieh Alikhasi
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
North kargar
City
Tehran
Province
Tehran
Postal code
1439955991
Phone
+98 21 8801 5950
Email
m_alikhasi@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ali Mahmoud Hashemi
Position
PHD Candidate
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
No. 43, Saiede ST, Niavaran Ave
City
Tehran
Province
Tehran
Postal code
1954811954
Phone
+98 21 2645 5649
Email
ali.mh.qq@gamil.com

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
When the data will become available and for how long
After finish
To whom data/document is available
All
Under which criteria data/document could be used
Clinical cares
From where data/document is obtainable
Dentistry faculty
What processes are involved for a request to access data/document
Form filling
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