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Study of Neodent Implantable Devices of GM Zygomatic Line

NCT04328116 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 16

Last updated 2023-11-09

No results posted yet for this study

Summary

GM Zygomatic implant is intended to be surgically placed in the posterior region of the maxilla and zygoma. It is indicated for multiple prostheses in case of severe resorption in the maxilla and total edentulism (situations in which the installation of convectional implants is contraindicated).

The objective of the study is to confirm the long-term safety and clinical performance of GM Zygomatic implants and GM Zygomatic abutments in daily dental practice setting, by means of a prospective collection of clinical data concerning the success and survival rates of these devices.

Devices will be used according to standard routine in daily practice, according to all indications as specified by the manufacturer in the instructions for use (IFU). Ten patients will be followed for 36 months and monitored for Adverse Events by the Investigators until the last protocol-related procedure of a patient is completed.

Conditions

  • Jaw, Edentulous

Interventions

DEVICE

Dental Implants

Dental Implants will be used according to standard routine in daily practice, according to all indications as specified by the manufacturer in the IFU (informations for use)

Sponsors & Collaborators

  • Neodent

    lead INDUSTRY

Principal Investigators

  • Larissa Trojan, PhD · Neodent

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-07-15
Primary Completion
2024-03-31
Completion
2024-03-31
FDA Device
Yes

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04328116 on ClinicalTrials.gov