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

NCT ID: NCT06277076

Last Updated: 2024-02-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

13 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-01-28

Study Completion Date

2023-08-15

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Dental Implant Computer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Saint-Joseph University

OTHER

Sponsor Role lead

Responsible Party

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Emile Chrabieh

Principal investigator, Head of Implant Dentistry Diploma program, Clinical Adjunct Professor.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Emile Chrabieh, Master

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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Saint Joseph University of Beirut/Dental school

Beirut, , Lebanon

Site Status

Countries

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Lebanon

References

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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.

Reference Type BACKGROUND
PMID: 29608793 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31642588 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20497439 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15142100 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30328191 (View on PubMed)

Other Identifiers

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FMD1234

Identifier Type: -

Identifier Source: org_study_id

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