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IRCT20211208053334N1 IRCT 2022-08-06 Tehran University of Medical Sciences Evaluation of Implant Placement by digital method Evaluation of Placement Accuracy (Precision & Trueness) In Digitally-guided Implants and Prefabricated Provisional Single-unit Restorations: A Clinical Trial Study 2022-08-11 anticipated 14 Complete https://irct.ir/trial/60771 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment, 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. N/A Partial loss of teeth, unspecified cause. Intervention group: single-unit implant placement in partially edentulous patients with the aid of surgical guides, which are designed (3shape dental system©) and printed after obtaining intraoral scan and CBCT radiographic records. Each patient undergoes a single-session surgery. Implant fixtures (DIO Implant©) are placed without incisions (flapless surgery) and according to the drilling protocols related to the fixture size. Customized healing abutments are inserted immediately after fixture placement. A post-surgical CBCT radiography will be taken after the surgery. Temporary crowns will be cemented (Hoffman zinc phosphate cement©) two weeks after the surgery, and a subsequent intraoral scan will be recorded. The actual fixture and crown position will be compared using post-surgical records. Patients will be set to come back after three months to assess the clinical success of the implants (early implant failure, bleeding on probing, and peri-implant probing depth).. Yes - There is a plan to make this available What will be shared: 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: Study documents will be available to applicants three months after the article's publication. To whom: Researchers in possession of a study proposal related to our study topic are eligible to receive the records. Conditions: Using study records for further investigations and analysis as well as combining these records with other studies to reach more comprehensive results are suitable. Where to obtain: records can be requested by contacting parsa.pirooz78@gmail.com How to obtain: 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. Comments:
public parsa pirooz
Hassanabad - Zargandeh ghadir alley omidvar alley Number 14 3rd floor
Tehran Iran (Islamic Republic of) 1916994696 +98 21 2200 7927 p-pirooz@student.tums.ac.ir Tehran University of Medical Sciences scientific parsa pirooz
Hassanabad - Zargandeh ghadir alley omidvar alley Number 14 3rd floor
Tehran Iran (Islamic Republic of) 1916994696 +98 21 2200 7929 p-pirooz@student.tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) at least two months after tooth extraction acceptable occlusion no limit no limit Both 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 K08.40 Partial loss of teeth, unspecified cause Treatment - Surgery Intervention group: single-unit implant placement in partially edentulous patients with the aid of surgical guides, which are designed (3shape dental system©) and printed after obtaining intraoral scan and CBCT radiographic records. Each patient undergoes a single-session surgery. Implant fixtures (DIO Implant©) are placed without incisions (flapless surgery) and according to the drilling protocols related to the fixture size. Customized healing abutments are inserted immediately after fixture placement. A post-surgical CBCT radiography will be taken after the surgery. Temporary crowns will be cemented (Hoffman zinc phosphate cement©) two weeks after the surgery, and a subsequent intraoral scan will be recorded. The actual fixture and crown position will be compared using post-surgical records. Patients will be set to come back after three months to assess the clinical success of the implants (early implant failure, bleeding on probing, and peri-implant probing depth). The difference in implant angulation of designed and actual implants. Timepoint: immediately after surgery. Method of measurement: post-surgical CBCT. The difference in apex location of designed and actual implants. Timepoint: immediately after surgery. Method of measurement: post-surgical CBCT. The difference in placement angle of designed and actual crowns. Timepoint: two weeks after surgery and placement of the temporary restoration. Method of measurement: post-operative intraoral scanning. The difference in crown depth of designed and actual crowns. Timepoint: two weeks after surgery and placement of the temporary restoration. Method of measurement: post-operative intraoral scanning. Early Implant Failure. Timepoint: up to three months after surgery. Method of measurement: clinical and radiographic examination. Bleeding on Probing. Timepoint: 3 months after surgery. Method of measurement: periodontal probing. Peri-implant probing depth. Timepoint: 3 months after surgery. Method of measurement: periodontal probing. Tehran University of Medical Sciences Approved 2021-12-19 Ethics committee of Tehran University of Medical Sciences Hassanabad - Zargandeh ghadir alley omidvar alley Number 14 3rd floor, Tehran, 1916994696, Iran Tehran Tehran Iran (Islamic Republic of)