NCT04328116

Study of Neodent Implantable Devices of GM Zygomatic Line

Name: Clinical Trial NCT04328116
Creator: Neodent
Keywords: Jaw, Edentulous, Dental Implants, device, clinical trial, Brazil

Prospective Case Series Study of Neodent Implantable Devices of GM Zygomatic Line

Neodent·ClinicalTrials.gov·device·Device trialRecruiting

View on ClinicalTrials.gov →

Study focus

Disease/Condition: Jaw, Edentulous
Drug/Device/Intervention: Dental Implants
Study type: Observational
Intervention type: device

Sponsor & location

Primary sponsor: Neodent
Location: Curitiba, Brazil

Timeline & enrollment

Phase: N/A
Start date: Jul 15, 2020
End date: Mar 01, 2024
Enrollment: 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 jawMottled teethDisorder of gingiva and edentulous alveolar ridge, unspecifiedOther disorders of gingiva and edentulous alveolar ridgeOther specified disorders of gingiva and edentulous alveolar ridge

Data source

Registry: ClinicalTrials.gov
Trial ID: NCT04328116
Type: Device Trial

About this record

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.