Accuracy of Dental Implant Position Robotic Assistance, Dynamic Navigation, or Static Guide?
- Conditions
- Dental Implant
- Interventions
- Device: Robotic systemDevice: Static guideDevice: Dynamic navigation
- Registration Number
- NCT05892406
- Lead Sponsor
- Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
- Brief Summary
For free hand dental implant placement, a key difficulty is to accurately control the position. Improving precision of dental implant placement is considered important for safety and efficacy of tooth replacement with dental implants. There are 3 available methods to improve implant position according to a digitally constructed prosthetically guided plan: the use of a 3D printed static guide, the use of a dynamic navigation system or the use of a robotic system. The goal of this randomized controlled trial is to compare the positional implant accuracy, the surgical time, and patient satisfaction among three methods of digital guidance: the use of a 3D printed static guide, dynamic navigation, and robotic assisted surgery. Patients requiring single tooth replacement with a dental implant will be digitally planned using a CBCT and an intraoral digital scan. Subjects will be randomized to one of the three treatment modalities based on the plan. The accuracy of placement will be assessed evaluating the difference between the planned and the actual position using a follow-up scan taken at the end of the surgery. Subjects will be followed up for one year to assess both patient reported and professional outcomes.
- Detailed Description
For free hand dental implant placement, a key difficulty is to accurately control the position. Improving precision of dental implant placement is considered important for safety and efficacy of tooth replacement with dental implants. There are 3 available methods to improve implant position according to a digitally constructed prosthetically guided plan: the use of a 3D printed static guide, the use of a dynamic navigation system or the use of a robotic system. The goal of this randomized controlled trial is to compare the positional implant accuracy, the surgical time, and patient satisfaction among three methods of digital guidance: the use of a 3D printed static guide, dynamic navigation, and robotic assisted surgery. Patients requiring single tooth replacement with a dental implant will be digitally planned using a CBCT and an intraoral digital scan. Subjects will be randomized to one of the three treatment modalities based on the plan. The accuracy of placement will be assessed evaluating the difference between the planned and the actual position using a follow-up scan taken at the end of the surgery. Platform deviation will be measured digitally. Subjects will be followed up for one year to assess both patient reported and professional outcomes and associate them with the precision of implant position.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 45
- Patient with a single missing tooth, with sufficient bone volume and keratinized tissue at edentulous site, willing to comply with research appointments/schedule.
- Pregnancy or intention to become pregnant at any point during the study duration; with any systematic diseases/conditions that are contradictions to dental implant treatment; inability or unwillingness of individual to give written informed consent; inability of follow-up according to the protocol.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Robotic system Robotic system Prosthetically guided Implant placement utilising robotic surgery based on a digital plan Static guide Static guide Prosthetically guided Implant placement utilising a 3D printed static guide based on a digital plan Dynamic navigation Dynamic navigation Prosthetically guided Implant placement utilising a dynamic navigation system based on a digital plan
- Primary Outcome Measures
Name Time Method Peri-implant soft tissue health 12 month follow-up Defined according to the peri-implant health case definition by Berglundh et al 2017 and the ID-COSM international consensus conference
Implant positional accuracy Immediately after surgery Implant accuracy will be measured as discrepancy between the digital plan and t actual position of the implant.
- Secondary Outcome Measures
Name Time Method Cytokine concentrations in PISF 12-months follow-up after delivery of crown Cytokine concentration in peri-implant sulcus fluid assesed by MULTIPLEX ELISA of IL-1, TNFa, IL-6 with lower concentrations representing less inflammation.
Surgery time intraoperative Time needed for surgery procedure will be recorded from anaesthesia to connection of cover screw/healing abutment.
Pain perception 7 days after surgery Patient pain perception after surgery will be recorded using visual analogue scale (VAS with range from 0 to 10 with 10 being the highest possible pain experience) .
Patient preference Immediately after surgery Assessed using a visual analogue scale (VAS, 100 mm, with 0=least desirable option and 100 = most desirable option.
Surgeon preference Immediately after surgery Assessed using a visual analogue scale (VAS, 100 mm, with 0=least desirable option and 100 = most desirable option.
Esthetics of the restoration 12-months follow-up after delivery of crown Assessed using the PES-WES scale as reported by Belser et al. with 0 being the worst and 14 the best value in the scale
Submarginal microbiome 12-months follow-up after delivery of crown 16S assessment of microbiome diversity (Shannon index) with greater diversity representing a more stable microbiome
Trial Locations
- Locations (2)
Shanghai Perio-Implant Innovation Center
🇨🇳Shanghai, Shanghai, China
Department of Oral and Maxillofacial Implantology
🇨🇳Shanghai, Shanghai, China