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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Dental Implant
• Intervention / Treatment: Device: Dynamic navigation; Device: Robotic system; Device: Static guide

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.

• Study Type: Interventional
• Enrollment (Estimated): 45
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jun-Yu Shi, PhD; Phone Number: 13636340883; Email: sjy0511@hotmail.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200011
      • Recruiting
      • Department of Oral and Maxillofacial Implantology
      • Contact: Jun-Yu Shi, MDS; Phone Number: 23271073
    • Shanghai, Shanghai, China, 201206
      • Recruiting
      • Shanghai Perio-Implant Innovation Center
      • Contact: Jojo Qian, PhD; Email: qianshujiao@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Static guide; Prosthetically guided Implant placement utilising a 3D printed static guide based on a digital plan	Device: Static guide; 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.
Active Comparator: Dynamic navigation; Prosthetically guided Implant placement utilising a dynamic navigation system based on a digital plan	Device: Dynamic navigation; Implant will be placed under the assistance of dynamic navigation.
Experimental: Robotic system; Prosthetically guided Implant placement utilising robotic surgery based on a digital plan	Device: Robotic system; Implant will be placed under robotic arm and human collaboration.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
• Investigators: Principal Investigator: Maurizio Tonetti, PhD, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2023
• Primary Completion (Estimated): October 30, 2024
• Study Completion (Estimated): November 15, 2024

Study Registration Dates

• First Submitted: May 29, 2023
• First Submitted That Met QC Criteria: June 6, 2023
• First Posted (Actual): June 7, 2023

Study Record Updates

• Last Update Posted (Actual): September 7, 2023
• Last Update Submitted That Met QC Criteria: September 5, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Accuracy; robotic surgery; dynamic surgical navigation; 3D printed static guide
• Other Study ID Numbers: SH9H-2023-T109

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No