Accuracy of Computer- Guided Implant Surgery in Partially Edentulous Patients.

Accuracy of Computer- Guided Implant Surgery in Partially Edentulous Patients: a Prospective Observational Study.

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.

Study Overview

• Status: Completed
• Conditions: Dental Implant; Computer
• Intervention / Treatment: Procedure: Computer Implant guided Surgery

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.

• Study Type: Observational
• Enrollment (Actual): 13

Contacts and Locations

Study Locations

• Lebanon
  • Beirut, Lebanon, 1107 2180
    • Saint Joseph University of Beirut/Dental school

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Patients presenting at Saint Joseph University of Beirut dental clinics with a distal-shortened mandible or distal intercalary space of two to three missing premolars or molars (class I, II or VI according to Kennedy's classification on edentulous spaces) and requiring implant-supported reconstructions were selected to participate in this study.

For each case two implants were placed with a fully guided procedure. Thirteen patients were included in this study with twenty-five implants eligible for accuracy evaluation.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assess Accuracy of Implant Placement in Vertical Displacement (VD).	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).	4 months
Assess Accuracy of Implant Placement in Horizontal Displacement (HD)	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).	4 months
Assess Accuracy of Implant Placement in Error Depth (ED)	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).	4 months
Assess Accuracy of Implant Placement in Error Angle (EA)	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).	4 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate Precision of the Printed Guide	Assess how precisely the printed guide translates the planned positions to the actual implant placements. Using the same assessment tool as for the primary outcome measure.	4 months
Study Complications and Adverse Events	Monitor and report any complications or adverse events associated with the use of the printed guide during implant placement.	4 months

Collaborators and Investigators

• Sponsor: Saint-Joseph University
• Investigators: Principal Investigator: Emile Chrabieh, Master, Faculty at the dental school, oral surgery department, Saint Joseph University of Beirut

Publications and helpful links

General Publications

• Arisan V, Karabuda CZ, Ozdemir T. Implant surgery using bone- and mucosa-supported stereolithographic guides in totally edentulous jaws: surgical and post-operative outcomes of computer-aided vs. standard techniques. Clin Oral Implants Res. 2010 Sep;21(9):980-8. doi: 10.1111/j.1600-0501.2010.01957.x. Epub 2010 May 24.
• Tahmaseb A, Wu V, Wismeijer D, Coucke W, Evans C. The accuracy of static computer-aided implant surgery: A systematic review and meta-analysis. Clin Oral Implants Res. 2018 Oct;29 Suppl 16:416-435. doi: 10.1111/clr.13346.
• Younes F, Cosyn J, De Bruyckere T, Cleymaet R, Bouckaert E, Eghbali A. A randomized controlled study on the accuracy of free-handed, pilot-drill guided and fully guided implant surgery in partially edentulous patients. J Clin Periodontol. 2018 Jun;45(6):721-732. doi: 10.1111/jcpe.12897. Epub 2018 May 10.
• Li J, Chen Z, Chan HL, Sinjab K, Yu H, Wang HL. Does flap opening or not influence the accuracy of semi-guided implant placement in partially edentulous sites? Clin Implant Dent Relat Res. 2019 Dec;21(6):1253-1261. doi: 10.1111/cid.12847. Epub 2019 Oct 23.
• van Steenberghe D, Molly L, Jacobs R, Vandekerckhove B, Quirynen M, Naert I. The immediate rehabilitation by means of a ready-made final fixed prosthesis in the edentulous mandible: a 1-year follow-up study on 50 consecutive patients. Clin Oral Implants Res. 2004 Jun;15(3):360-5. doi: 10.1111/j.1600-0501.2004.01069.x.

Study record dates

Study Major Dates

• Study Start (Actual): January 28, 2023
• Primary Completion (Actual): May 2, 2023
• Study Completion (Actual): August 15, 2023

Study Registration Dates

• First Submitted: January 13, 2024
• First Submitted That Met QC Criteria: February 17, 2024
• First Posted (Actual): February 26, 2024

Study Record Updates

• Last Update Posted (Actual): February 26, 2024
• Last Update Submitted That Met QC Criteria: February 17, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Accuracy; dental implant; Surgical template; Surgical guide; Guided surgery; Computer-aided design (CAD); Computer-aided manufacturing (CAM)
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Mouth Diseases; Tooth Diseases; Mouth, Edentulous
• Other Study ID Numbers: FMD1234

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No