Clinical trial NCT06277076: Accuracy of Computer- Guided Implant Surgery in Partially Edentulous Patients.
Official title: Accuracy of Computer- Guided Implant Surgery in Partially Edentulous Patients: a Prospective Observational Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dental Implant
Computer
Keywords: dental implant
Accuracy
Computer-aided design (CAD)
Guided surgery
Surgical guide
Surgical template
Computer-aided manufacturing (CAM)
Lead sponsor: Saint-Joseph University
Sponsor class: OTHER
First posted: 2024-02-26
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Assess Accuracy of Implant Placement in Vertical Displacement (VD).
timeFrame: 4 months
measure: Assess Accuracy of Implant Placement in Horizontal Displacement (HD)
timeFrame: 4 months
measure: Assess Accuracy of Implant Placement in Error Depth (ED)
timeFrame: 4 months
measure: Assess Accuracy of Implant Placement in Error Angle (EA)
timeFrame: 4 months
Secondary outcomes:
measure: Evaluate Precision of the Printed Guide
timeFrame: 4 months
measure: Study Complications and Adverse Events
timeFrame: 4 months
Other outcomes:
Locations:
city: Beirut
country: Lebanon
facility: Saint Joseph University of Beirut/Dental school
Study officials:
affiliation: Faculty at the dental school, oral surgery department, Saint Joseph University of Beirut
name: Emile Chrabieh, Master
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
citation: 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.
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.
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.