NCT05892406

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2023

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 29, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 7, 2023

Completed
24 days until next milestone

Study Start

First participant enrolled

July 1, 2023

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2024

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2024

Completed
Last Updated

September 7, 2023

Status Verified

September 1, 2023

Enrollment Period

1.3 years

First QC Date

May 29, 2023

Last Update Submit

September 5, 2023

Conditions

Dental Implant

Keywords

robotic surgerydynamic surgical navigation3D printed static guideAccuracy

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (8)

  • Surgery time

    intraoperative

  • Pain perception

    Immediately after surgery

  • Pain perception

    7 days after surgery

  • Patient preference

    Immediately after surgery

  • Surgeon preference

    Immediately after surgery

  • +3 more secondary outcomes

Study Arms (3)

Static guide

ACTIVE COMPARATOR

Prosthetically guided Implant placement utilising a 3D printed static guide based on a digital plan

Device: Static guide

Dynamic navigation

ACTIVE COMPARATOR

Prosthetically guided Implant placement utilising a dynamic navigation system based on a digital plan

Device: Dynamic navigation

Robotic system

EXPERIMENTAL

Prosthetically guided Implant placement utilising robotic surgery based on a digital plan

Device: Robotic system

Interventions

Static guideDEVICE

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.

Static guide
Dynamic navigationDEVICE

Implant will be placed under the assistance of dynamic navigation.

Dynamic navigation
Robotic systemDEVICE

Implant will be placed under robotic arm and human collaboration.

Robotic system

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient with a single missing tooth, with sufficient bone volume and keratinized tissue at edentulous site, willing to comply with research appointments/schedule.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Department of Oral and Maxillofacial Implantology

Shanghai, Shanghai Municipality, 200011, China

RECRUITING

Shanghai Perio-Implant Innovation Center

Shanghai, Shanghai Municipality, 201206, China

RECRUITING

Study Officials

  • Maurizio Tonetti, PhD

    Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jun-Yu Shi, PhD

CONTACT

13636340883sjy0511@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 29, 2023

First Posted

June 7, 2023

Study Start

July 1, 2023

Primary Completion

October 30, 2024

Study Completion

November 15, 2024

Last Updated

September 7, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

CN(2)