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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-01

Study Completion Date

2024-11-15

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.

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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.

Conditions

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Dental Implant

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Static guide

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

Group Type ACTIVE_COMPARATOR

Static guide

Intervention Type DEVICE

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

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

Group Type ACTIVE_COMPARATOR

Dynamic navigation

Intervention Type DEVICE

Implant will be placed under the assistance of dynamic navigation.

Robotic system

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

Group Type EXPERIMENTAL

Robotic system

Intervention Type DEVICE

Implant will be placed under robotic arm and human collaboration.

Interventions

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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.

Intervention Type DEVICE

Dynamic navigation

Implant will be placed under the assistance of dynamic navigation.

Intervention Type DEVICE

Robotic system

Implant will be placed under robotic arm and human collaboration.

Intervention Type DEVICE

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes