Accuracy of Dental Implant Placement Using a Collaborative Surgery Robot

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

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-16

Study Completion Date

2024-11-30

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. The goal of this randomized controlled trial is to compare the positional implant accuracy, and patient reported outcomes comparing two methods of implant placement: the use of a robotic assisted surgery and freehand 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 two 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 CBCT immediately after 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. In particular, more precise implant placement is expected to yield a better restoration both in terms of aesthetics and ability for self-performed oral hygiene and thus prevention of peri-implant diseases. The goal of this randomized controlled trial is to compare the positional implant accuracy, and patient reported outcomes comparing two methods of implant placement: the use of a robotic assisted surgery and freehand 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 two 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 CBCT immediately after surgery. Subjects will be followed up for one year to assess both patient reported and professional outcomes.

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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Robot system

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

Group Type EXPERIMENTAL

Robot system

Intervention Type PROCEDURE

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

Freehand surgery

Freehand implant placement by experienced surgeon.

Group Type SHAM_COMPARATOR

Freehand surgery

Intervention Type PROCEDURE

Freehand implant placement by experienced surgeon.

Interventions

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Robot system

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

Intervention Type PROCEDURE

Freehand surgery

Freehand implant placement by experienced surgeon.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patient with a single missing tooth to be replaced with a dental implant
* 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 systemic diseases/conditions that are contraindications 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