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

Dental Implant Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05892406
• Other study ID #: SH9H-2023-T109
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2023
• Est. completion date: November 15, 2024

Study information

• Verified date: September 2023
• Source: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
• Contact: Jun-Yu Shi, PhD
• Phone: 13636340883
• Email: sjy0511[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: November 15, 2024
• Est. primary completion date: October 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dental Implant

Intervention

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.
• Dynamic navigation
Implant will be placed under the assistance of dynamic navigation.
• Robotic system
Implant will be placed under robotic arm and human collaboration.

Locations

Country	Name	City	State
China	Department of Oral and Maxillofacial Implantology	Shanghai	Shanghai
China	Shanghai Perio-Implant Innovation Center	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Implant positional accuracy	Implant accuracy will be measured as discrepancy between the digital plan and t actual position of the implant.	Immediately after surgery
Primary	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	Surgery time	Time needed for surgery procedure will be recorded from anaesthesia to connection of cover screw/healing abutment.	intraoperative
Secondary	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
Secondary	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
Secondary	Patient preference	Assessed using a visual analogue scale (VAS, 100 mm, with 0=least desirable option and 100 = most desirable option.	Immediately after surgery
Secondary	Surgeon preference	Assessed using a visual analogue scale (VAS, 100 mm, with 0=least desirable option and 100 = most desirable option.	Immediately after surgery
Secondary	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
Secondary	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
Secondary	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