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Completed

NCT Number: NCT06277076

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

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.

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Key information

Conditions

Dental Implant Computer

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Saint Joseph University of Beirut/Dental school

Beirut, 1107 2180, Lebanon

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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).

  2. 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).

  3. 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).

  4. 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

  1. Evaluate Precision of the Printed Guide

    Time frame: 4 months

    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.

  2. Study Complications and Adverse Events

    Time frame: 4 months

    Monitor and report any complications or adverse events associated with the use of the printed guide during implant placement.

Sponsors and collaborators

Lead sponsor

Saint-Joseph University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Feb 26, 2024
Registry last updated
Feb 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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