Flapless Zygomatic Implants Robot-assisted Placement

NCT ID: NCT05565157

Last Updated: 2024-07-10

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

RECRUITING

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-30

Study Completion Date

2024-12-31

Brief Summary

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Zygomatic implants are indicated for the rehabilitation of the severely atrophic maxilla. Similar to standard implant placement, gaining an optimal position of the zygomatic implants is essential for a predictable prosthetic-driven treatment outcome.

However, there is no effective mechanism to physically control the drilling trajectory for the zygomatic implants. Therefore, deviation between the actual and planned implant position is inevitable.

This approach is technically difficult, and is performed by an experienced surgeon.

The development of a surgical technique that is both safer and less invasive is currently possible thanks to robotics. In this project, a robotic assisted new strategy for positioning zygomatic implants will be performed and its efficacy and accuracy will be assess.

Path planning will be carried out on a pre-operative scanner. The ROSA robot (Zimmer®) will guide the several drillings steps. Placement of the zygomatic implant will be performed manually.

Detailed Description

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Conditions

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Zygomatic Implant Robotic

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Interventions

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Zygomatic implants

A robotic assisted new strategy for positioning zygomatic implants will be performed and its efficacy and accuracy will be assess

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patients suffering from Maxillary edentulism with severe bone resorption
* Patients suffering from maxillary edentulism post maxillary defect (carcinologic or traumatic) and free flap reconstruction
* Patients suffering from post-maxillectomy buccosinusal communication.
* Age ≥ 18 years old
* Having signed the informed consent

Exclusion Criteria

* Patients suffering from chronic sinusitis
* Patients refusing ROSA robot-guided surgery (unsigned informed consent).
* Pregnant and nursing women
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire, Amiens

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHU Amiens

Amiens, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Sylvie TESTELIN, Pr

Role: CONTACT

03.22.08.90.50

Facility Contacts

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Sylvie Testellin, Pr

Role: primary

03 22 08 90 50

Other Identifiers

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PI2020_843_0076

Identifier Type: -

Identifier Source: org_study_id

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