Neodent Implantable Devices of GM Line

Launched by NEODENT · Jan 22, 2019

Keywords

ClinConnect Summary

The study protocol was reviewed and approved by an Ethics Committee (CE) in Brazil.

The sample will be prospectively and consecutively selected and will consist of patients who are 18 years of age or older, who are in need of one or more dental implants and who qualify for placement of Neodent GM Helix implants. Informed consent in writing will be obtained from each patient participating in the study prior to any study related procedure.

Neodent Acqua GM Helix implants will be placed under local anesthesia and with adequate bone bed preparation, as recommended by the manufacturer. Multipl...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 18 years of age or older;
• • Need of one or more dental implants;
• • Qualify for placement of Neodent GM Helix implants.
• Exclusion Criteria:
• As exclusion criteria, solely the device contraindications according to the IFU (instructions for use) will be applied:
• • Signs of allergy or hypersensitivity to the chemical ingredients of the material: titanium alloy;
• • Presence of acute inflammatory or infectious processes in live tissue;
• • Unsuitable bone volume or quality;
• • Serious medical problems (e.g. bone metabolism disorders, blood clotting disorders, unsuitable healing capacity);
• • Insufficient oral hygiene;
• • Incomplete jawbone growth;
• • Patient uncooperative and not motivated;
• • Abuse of drugs or alcohol;
• • Psychosis;
• • Prolonged functional disorders which resist any treatment with medications;
• • Xerostomia;
• • Weakened immunological system;
• • Diseases which require the use of steroids;
• • Uncontrolled endocrinological diseases;
• • Pregnancy.