Accuracy of Computer- Guided Implant Surgery in Partially Edentulous Patients: a Prospective Observational Study.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Dental Implant
- Sponsor
- Saint-Joseph University
- Enrollment
- 13
- Locations
- 1
- Primary Endpoint
- Assess Accuracy of Implant Placement in Vertical Displacement (VD).
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
The dental implant placed freehand with a digital planing is vastly increasing. The accuracy between the planned and the placed implants still not well determined. Between a single implant and a full mouth rehabilitation, the precision is very wide. A precision scale must be settled according to each indication in order to offer the clinician a safety and a predictability for his procedures.
Detailed Description
In this paper the investigators report an original research evaluating the accuracy of computer-guided implant placement in posterior edentulous mandibular spaces. In this randomized controlled trial, several factors were evaluated such as primary implant stability, possibility of immediate loading, displacement at crestal and apical levels, angle of deviation, surgical guide design, computer-aided design and computer-aided manufacturing accuracy, and variance between different implant macro-geometries and lengths. As exhaustive description of the assessment techniques as well as the statistic results were also presented in this article. Nowadays, the use of guided surgery is vastly increasing in a daily dental practice. In the "Era of Digital Dentistry", it is of utmost importance to evaluate the accuracy and precision of the computer-guided techniques in order to determine their limits, avoid risks (adjacent anatomical structures, limited crestal volume, immediate loading), and apply them in safe manner. Evidence-based scientific data on this matter is still deficient. In these terms, the investigators consider it very interesting and of high clinical value for all oral surgeons and dental practitioners to evaluate in a clinical research the precision and distortion of computer-guided implant surgery.
Investigators
Emile Chrabieh
Principal investigator, Head of Implant Dentistry Diploma program, Clinical Adjunct Professor.
Saint-Joseph University
Eligibility Criteria
Inclusion Criteria
- •Acceptable oral hygiene with no signs of active periodontal disease or local infection
- •American Society of Anesthesiologists (ASA) physical status classification 1 and 2
- •Non or Light smoking (\< 10 cigarettes per day)
- •Acceptable intermaxillary space (44 mm minimum)
- •Minimal crestal width of 5.5mm
- •Minimal residual bone height of 10mm above the alveolar nerve canal
Exclusion Criteria
- •Head and neck irradiation
- •Bone grafted sites
- •Severe bruxism
- •Cone Beam Computed tomography with exaggerated artifacts
- •Limited intermaxillary space
Outcomes
Primary Outcomes
Assess Accuracy of Implant Placement in Vertical Displacement (VD).
Time Frame: 4 months
Evaluate the accuracy of implant placement by comparing the planned positions (from the computer) with the actual positions of the placed implants (using the printed guide). The tool to assess the accuracy/deviation is a software that superimpose two "Digital Imaging and Communications in Medicine" (DCM) Files of the planned and the actual position implants. the first DCM issued from the planning software and second DCM file after scanning the implant in the jaw. The first outcome measure was provided to calculate the amount of distortion in millimeter (mm) for the Vertical Displacement (VD) (mm).
Assess Accuracy of Implant Placement in Horizontal Displacement (HD)
Time Frame: 4 months
Evaluate the accuracy of implant placement by comparing the planned positions (from the computer) with the actual positions of the placed implants (using the printed guide). The tool to assess the accuracy/deviation is a software that superimpose two "Digital Imaging and Communications in Medicine" (DCM) Files of the planned and the actual position implants. the first DCM issued from the planning software and second DCM file after scanning the implant in the jaw. The second outcome measure was provided to calculate the amount of distortion in millimeter (mm) for the Horizontal Displacement (HD).
Assess Accuracy of Implant Placement in Error Depth (ED)
Time Frame: 4 months
Evaluate the accuracy of implant placement by comparing the planned positions (from the computer) with the actual positions of the placed implants (using the printed guide). The tool to assess the accuracy/deviation is a software that superimpose two "Digital Imaging and Communications in Medicine" (DCM) Files of the planned and the actual position implants. the first DCM issued from the planning software and second DCM file after scanning the implant in the jaw. The third outcome measure was provided to calculate the amount of distortion in millimeter (mm) for the Error Depth (ED) (mm).
Assess Accuracy of Implant Placement in Error Angle (EA)
Time Frame: 4 months
Evaluate the accuracy of implant placement by comparing the planned positions (from the computer) with the actual positions of the placed implants (using the printed guide). The tool to assess the accuracy/deviation is a software that superimpose two "Digital Imaging and Communications in Medicine" (DCM) Files of the planned and the actual position implants. the first DCM issued from the planning software and second DCM file after scanning the implant in the jaw. The fourth outcome measure was provided to calculate the amount of distortion in in degree of the Error Angle (EA).
Secondary Outcomes
- Evaluate Precision of the Printed Guide(4 months)
- Study Complications and Adverse Events(4 months)