Evaluation of Placement Accuracy (Precision & Trueness) In Digitally-guided Implants and Prefabricated Provisional Single-unit Restorations: A Clinical Trial Study
Evaluating the accuracy of digitally-guided implant placement and single-unit prefabricated temporary restorations
Design
This study has only one intervention group and no control group. The sample size was calculated based on the Valente 2009 study and the two main variables of Lateral Apical Deviation and Angular Deviation. 14 implant units will be included.
Settings and conduct
All patients are examined and treated in the faculty of dentistry at Tehran University of Medical Sciences. Surgical guides, customized abutments, and temporary crowns are designed in the virtual environment using CBCT records and intraoral scans. Surgical guides, customized abutments, and temporary crowns are manufactured. After performing a flapless implant surgery using the surgical guide and installing the customized abutment, a post-surgical CBCT radiography will be taken. Another intraoral scan is taken after cementing the temporary crown. Implant and crown locations are compared with their designed position using 3shape software.
Participants/Inclusion and exclusion criteria
Patients who need single-implant crowns are included (there might be multiple sites in the mouth that needs implants, but no one receives adjacent implants). Cases that require graft or sinus lift surgery before implant placement were excluded.
Intervention groups
Patients needing single-unit implant restorations will be included in the only intervention group. These patients will receive digitally-guided implants, customized abutments, and temporary crowns.
Evaluation of Placement Accuracy (Precision & Trueness) In Digitally-guided Implants and Prefabricated Provisional Single-unit Restorations: A Clinical Trial Study
Public title
Evaluation of Implant Placement by digital method
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
at least two months after tooth extraction
acceptable occlusion
Exclusion criteria:
presence of a systemic disease
smoking
contraindication for surgical procedures
presence of parafunctional habits
presence of TMJ complications
need for graft or sinus lift surgery
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
14
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
this study includes only one group of patients. the aim of this study is to compare the position of implant and its temporary restoration with its digitally designed counterpart. As a result, there is no blinding or randomization in this study.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Hassan abad - zargandeh, Ghadir alley, Omidvar alley, Number 14, 3rd floor
City
Tehran
Province
Tehran
Postal code
1916994696
Phone
+98 21 2200 7927
Fax
Email
P-pirooz@student.tums.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
Not applicable
Title and more details about the data/document
Radiographic records, intraoral scans, and virtual designs for surgical guides, customized abutments, and temporary crowns will be available. These records don't allow patient recognition; each will be merely made related to an intraoral scan.
When the data will become available and for how long
Study documents will be available to applicants three months after the article's publication.
To whom data/document is available
Researchers in possession of a study proposal related to our study topic are eligible to receive the records.
Under which criteria data/document could be used
Using study records for further investigations and analysis as well as combining these records with other studies to reach more comprehensive results are suitable.
From where data/document is obtainable
records can be requested by contacting parsa.pirooz78@gmail.com
What processes are involved for a request to access data/document
The request will be assessed based on the study proposal and the researchers' intent to use the records. The records will be immediately provided after it is established that there is no possibility of misuse.