Assessment of the Accuracy of Artificial Intelligence Assisted Workflow Versus Conventional Workflow in Computer Guided Implant Placement: A Randomized Controlled Clinical Trial.
Trial Snapshot
- Phase
- Phase 4
- Status
- Recruiting
- Sponsor
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Linear Discrepancy
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 50 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Computer guided implant placement using artificial intelligence assisted designing and manufacturing
Intervention: Conventional computer guided implant placement (Procedure)
Computer guided implant placement using conventional digital workflow in designing and manufacturing
Intervention: AI assisted implant placement (Procedure)
Outcomes
Primary Outcomes
Linear Discrepancy
Time Frame: Immediate post operative
The linear implant position discrepancy between the plan and the actual implant position in millimeters will be assessed using a specialized software.
Angular Discrepancy
Time Frame: Immediate post operative
The angular implant position discrepancy between the plan and the actual implant position in degrees will be assessed using a specialized software.
CAD Timing
Time Frame: Immediate post operative
The time elapsed for AI assisted CAD, will be compared to time elapsed during conventional CAD workflow in seconds using a stopwatch.
Secondary Outcomes
No secondary outcomes reported
Investigators
Sandra Moussa Botros El Tarzi
Researcher
Cairo University