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

NCT06277076 | Completed

• 1 other identifier: FMD1234
• Study Type: observational
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

Dental Implant; Computer

Keywords

dental implant; Accuracy; Computer-aided design (CAD); Guided surgery; Surgical guide; Surgical template; Computer-aided manufacturing (CAM)

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (2)

• Evaluate Precision of the Printed Guide

  4 months

• Study Complications and Adverse Events

  4 months

Interventions

Computer Implant guided Surgery PROCEDURE

Dental implant placed using printed guide after a digital planification on a superimposed 3D surface scan and a 3D Cone Beam imaging of the jaw.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Head and neck irradiation
• Bone grafted sites
• Severe bruxism
• Cone Beam Computed tomography with exaggerated artifacts
• Limited intermaxillary space

Sponsors & Collaborators

• Saint-Joseph University: lead

Study Sites (1)

Saint Joseph University of Beirut/Dental school

Beirut, 1107 2180, Lebanon

Location

Related Publications (5)

• 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.

  PMID: 29608793 BACKGROUND

• 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.

  PMID: 31642588 BACKGROUND

• 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.

  PMID: 20497439 BACKGROUND

• 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.

  PMID: 15142100 BACKGROUND

• 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.

  PMID: 30328191 BACKGROUND

Study Officials

• Emile Chrabieh, Master

  Faculty at the dental school, oral surgery department, Saint Joseph University of Beirut

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 4 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator, Head of Implant Dentistry Diploma program, Clinical Adjunct Professor.

Study Record Dates

• First Submitted: January 13, 2024
• First Posted: February 26, 2024
• Study Start: January 28, 2023
• Primary Completion: May 2, 2023
• Study Completion: August 15, 2023
• Last Updated: February 26, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

LE (1)