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Study of Neodent Implantable Devices of GM Zygomatic Line - Trial NCT04328116

Access comprehensive clinical trial information for NCT04328116 through Pure Global AI's free database. This phase not specified trial is sponsored by Neodent and is currently Recruiting. The study focuses on Jaw, Edentulous. Target enrollment is 10 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.

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Trial Details
ClinicalTrials.gov โ€ข NCT04328116
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Study of Neodent Implantable Devices of GM Zygomatic Line
Prospective Case Series Study of Neodent Implantable Devices of GM Zygomatic Line

Study Focus

Jaw, Edentulous

Dental Implants

Observational

device

Sponsor & Location

Neodent

Curitiba, Brazil

Timeline & Enrollment

N/A

Jul 15, 2020

Mar 01, 2024

10 participants

Primary Outcome

Implant survival rate,Implant success rate

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.

ICD-10 Classifications

Dislocation of jaw
Mottled teeth
Disorder of gingiva and edentulous alveolar ridge, unspecified
Other disorders of gingiva and edentulous alveolar ridge
Other specified disorders of gingiva and edentulous alveolar ridge

Data Source

ClinicalTrials.gov

NCT04328116

Device Trial