Artificial Intelligence Assisted Workflow Versus Conventional Workflow in Guided Implant Placement

Official title

Assessment of the Accuracy of Artificial Intelligence Assisted Workflow Versus Conventional Workflow in Computer Guided Implant Placement: A Randomized Controlled Clinical Trial.

Overview

The AI assisted CAD/CAM workflow will be adopted for the treatment planning and guide design generation with the aim of comparing precision of implant placement with conventional digital workflow.

Detailed description

The study will be conducted in Oral and Maxillofacial Department, Faculty of Oral and Dental Medicine, Cairo University.After patient's selection, the CBCTs will be captured for the edentulous area along with a full arch PVS impression for the upper and lower arches. The patients will then be randomly allocated into two groups. Group I, AI assisted group, the AI assisted workflow will be adopted for the treatment planning and guide design generation. Then, the surgical guide with the embedded sleeve will be designed and 3D printed. For Group II, Static CAIS group, the virtual implant planning for all patients will be done by one qualified experienced dentist in implant dentistry. Then, the surgical guide with the embedded sleeve will be designed and 3D printed with computer-aided design/computer-aided manufacturing (CAD/CAM) technology. The guides will then be disinfected to be ready for the surgical procedure. All patients will be administered 400 mg Ibuprofen 1 hour prior to surgery and will be instructed to rinse with a 0.12% Chlorhexidine solution for 60 s. After administration of local anesthesia,implant placement will be performed according to the allocated treatment protocol by one experienced surgeon. The following process will be the same for both guided techniques. The fit and stability of the 3D surgical guide will be verified prior to the surgery through tactile inspection and confirming the fit through the inspection window areas of the guide on top of the teeth. Implant bed preparations and implant insertions will be done through the 3D surgical guide in accordance with the manufacturer\'s fully guided surgical protocol. The drilling sequence will be followed as needed for each case. The implant will be placed via a fully guided implant placement regimen and a healing abutment will be placed for transmucosal healing. Wound suturing will be performed as needed and all the patients will receive postoperative instructions and will be appointed for a follow up and suture removal visit one week postoperatively. All patients will have an immediate postoperative CBCT.

The postoperative medications list will include systemic antibiotics (1 g of amoxicillin, twice a day) and an analgesic (500 mg of mefenamic acid, three times a day) for 5 days. For patients who were allergic to penicillin, 300 mg of clindamycin will be prescribed three times a day.

Interventions

• Procedure AI assisted implant placement
  the AI assisted workflow will be adopted for the treatment planning and guide design generation. Then, the surgical guide with the embedded sleeve will be designed and 3D printed.
• Procedure Conventional computer guided implant placement
  The virtual implant planning for all patients will be done by one qualified experienced dentist in implant dentistry. Then, the surgical guide with the embedded sleeve will be designed using the conventional CAD steps for static guide design and 3D printed with computer-aided design/computer-aided manufacturing (CAD/CAM) technology.

Primary outcome measures

• Linear Discrepancy [Time frame: Immediate post operative]
• Angular Discrepancy [Time frame: Immediate post operative]
• CAD Timing [Time frame: Immediate post operative]

Eligibility criteria

Inclusion criteria

• Kennedy class III partially edentulous patient with or without modifications.
• Patients who need single implant posterior site delayed implant placement.
• Patients above 18 and below 60 years of age.
• Natural healthy neighboring teeth without need of new restorations.

Exclusion criteria

• Patients with D4 bone density.
• Patients with known systemic or local diseases or treatments which can affect normal tissue healing.
• Patients who are heavy smokers.
• Presence of signs of active infection or pus formation.
• Patients with a need for implants in the anterior region.
• Additional oral surgery in the region of interest.
• Need For Bone grafting.
• Pregnant and/or lactating women

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

Egypt · 1 center

• Faculty of Dentistry - Cairo University — Cairo

Publications

• Zhou W, Liu Z, Song L, Kuo CL, Shafer DM. Clinical Factors Affecting the Accuracy of Guided Implant Surgery-A Systematic Review and Meta-analysis. J Evid Based Dent Pract. 2018 Mar;18(1):28-40. doi: 10.1016/j.jebdp.2017.07.007. Epub 2017 Jul 22. PMID 29478680
• 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. PMID 29608793
• Van de Velde T, Glor F, De Bruyn H. A model study on flapless implant placement by clinicians with a different experience level in implant surgery. Clin Oral Implants Res. 2008 Jan;19(1):66-72. doi: 10.1111/j.1600-0501.2007.01423.x. Epub 2007 Oct 22. PMID 17956565
• Takacs A, Hardi E, Cavalcante BGN, Szabo B, Kispelyi B, Joob-Fancsaly A, Mikulas K, Varga G, Hegyi P, Kivovics M. Advancing accuracy in guided implant placement: A comprehensive meta-analysis: Meta-Analysis evaluation of the accuracy of available implant placement Methods. J Dent. 2023 Dec;139:104748. doi: 10.1016/j.jdent.2023.104748. Epub 2023 Oct 19. PMID 37863173
• Smitkarn P, Subbalekha K, Mattheos N, Pimkhaokham A. The accuracy of single-tooth implants placed using fully digital-guided surgery and freehand implant surgery. J Clin Periodontol. 2019 Sep;46(9):949-957. doi: 10.1111/jcpe.13160. Epub 2019 Jul 19. PMID 31241782
• Shujaat S, Riaz M, Jacobs R. Synergy between artificial intelligence and precision medicine for computer-assisted oral and maxillofacial surgical planning. Clin Oral Investig. 2023 Mar;27(3):897-906. doi: 10.1007/s00784-022-04706-4. Epub 2022 Nov 3. PMID 36323803
• Shirmohammadi A, Ghertasi Oskouei S. The growing footprint of artificial intelligence in periodontology & implant dentistry. J Adv Periodontol Implant Dent. 2023 Jun 11;15(1):1-2. doi: 10.34172/japid.2023.012. eCollection 2023. No abstract available. PMID 37645551
• Murphy DC, Saleh DB. Artificial Intelligence in plastic surgery: What is it? Where are we now? What is on the horizon? Ann R Coll Surg Engl. 2020 Oct;102(8):577-580. doi: 10.1308/rcsann.2020.0158. Epub 2020 Aug 11. PMID 32777930

Identifiers

NCT: NCT07523815 · sandra.eltarzi1

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗