Accuracy of Dental Implant Position Robotic Assistance, Dynamic Navigation, or Static Guide?

Study Overview
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Brief Summary
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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
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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.

Official Title
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3 Dimensional Accuracy of Dental Implant Placement: Randomised Controlled Trial Comparing Robotic Assistance, Dynamic Navigation, and Static Guide

Conditions
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Dental Implant

Intervention / Treatment
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* Device: Static guide
* Device: Dynamic navigation
* Device: Robotic system


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient with a single missing tooth, with sufficient bone volume and keratinized tissue at edentulous site, willing to comply with research appointments/schedule. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Static guide<br>Prosthetically guided Implant placement utilising a 3D printed static guide based on a digital plan | Device: Static guide<br>* A static guide will be designed and fabricated based on CBCT and intra-oral scan. Implant will be placed under the assistance of statistic guide through the whole procedure.<br>|
| Active Comparator: Dynamic navigation<br>Prosthetically guided Implant placement utilising a dynamic navigation system based on a digital plan | Device: Dynamic navigation<br>* Implant will be placed under the assistance of dynamic navigation.<br>|
| Experimental: Robotic system<br>Prosthetically guided Implant placement utilising robotic surgery based on a digital plan | Device: Robotic system<br>* Implant will be placed under robotic arm and human collaboration.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Implant positional accuracy | Implant accuracy will be measured as discrepancy between the digital plan and t actual position of the implant. | Immediately after surgery | 
| Peri-implant soft tissue health | Defined according to the peri-implant health case definition by Berglundh et al 2017 and the ID-COSM international consensus conference | 12 month follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgery time | Time needed for surgery procedure will be recorded from anaesthesia to connection of cover screw/healing abutment. | intraoperative | 
| Pain perception | Patient pain perception during surgery will be recorded using visual analogue scale (VAS with range from 0 to 10 with 10 being the highest possible pain experience) . | Immediately after surgery | 
| Pain perception | 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) . | 7 days after surgery | 
| Patient preference | Assessed using a visual analogue scale (VAS, 100 mm, with 0=least desirable option and 100 = most desirable option. | Immediately after surgery | 
| Surgeon preference | Assessed using a visual analogue scale (VAS, 100 mm, with 0=least desirable option and 100 = most desirable option. | Immediately after surgery | 
| Esthetics of the restoration | 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 | 12-months follow-up after delivery of crown | 
| Cytokine concentrations in PISF | Cytokine concentration in peri-implant sulcus fluid assesed by MULTIPLEX ELISA of IL-1, TNFa, IL-6 with lower concentrations representing less inflammation. | 12-months follow-up after delivery of crown | 
| Submarginal microbiome | 16S assessment of microbiome diversity (Shannon index) with greater diversity representing a more stable microbiome | 12-months follow-up after delivery of crown | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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robotic surgery, dynamic surgical navigation, 3D printed static guide, Accuracy