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

Dental Implant Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06277076
• Other study ID #: FMD1234
• Status: Completed
• Start date: January 28, 2023
• Est. completion date: August 15, 2023

Study information

• Verified date: February 2024
• Source: Saint-Joseph University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: August 15, 2023
• Est. primary completion date: May 2, 2023
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Computer
• Dental Implant
• Mouth, Edentulous

Intervention

Procedure:
• Computer Implant guided Surgery
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.

Locations

Country	Name	City	State
Lebanon	Saint Joseph University of Beirut/Dental school	Beirut

Sponsors (1)

Lead Sponsor	Collaborator
Saint-Joseph University

Country where clinical trial is conducted

Lebanon, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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