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Dental ImplantNCT06277076

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

An observational study of Dental Implant and Computer, run by Saint-Joseph University at 1 site in Lebanon.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Dental Implant, Computer
What is being tested?
Computer Implant guided Surgery
Type of treatment
Surgery or procedure
How many people
13 participants
Where
1 siteLebanon
Study dates
28 Jan 2023to 15 Aug 2023
How long will I take part?
4 Months
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Lebanon1 site

  • Saint Joseph University of Beirut/Dental school

    Beirut, 1107 2180

Other trials in Lebanon

About this study

Official title: 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.

Read the 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.

Being tested
Computer Implant guided Surgery
Keywords
dental implant, Accuracy, Computer-aided design (CAD), Guided surgery, Surgical guide, Surgical template, Computer-aided manufacturing (CAM)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Computer Implant guided SurgeryProcedure or 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: 4 months

  2. 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).

    Measured: 4 months

  3. 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).

    Measured: 4 months

  4. 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).

    Measured: 4 months

Secondary outcomes (2)

  1. 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.

    Measured: 4 months

  2. Study Complications and Adverse Events

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

    Measured: 4 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Feb 2024
  2. Study start28 Jan 2023
  3. Primary completion2 May 2023
  4. Study completion15 Aug 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
13 participants (actual)
Target duration
4 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT06277076
Sponsor's protocol ID
FMD1234
Status last verified
Feb 2024
First submitted
13 Jan 2024
Last updated
26 Feb 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 29608793

  • 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.

    PubMed 31642588

  • 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.

    PubMed 20497439

  • 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.

    PubMed 15142100

  • 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.

    PubMed 30328191

Questions about this trial

What is this clinical trial studying?

An observational study of Dental Implant and Computer, run by Saint-Joseph University at 1 site in Lebanon.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Lebanon. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Assess Accuracy of Implant Placement in Vertical Displacement (VD). (time frame: 4 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06277076, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2024.

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