Status:
UNKNOWN
Study of Neodent Implantable Devices of GM Zygomatic Line
Lead Sponsor:
Neodent
Conditions:
Jaw, Edentulous
Eligibility:
All Genders
18+ years
Brief 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 tota...
Detailed Description
The study protocol was reviewed and approved by an Ethics Committee (CE) in Brazil. GM Zygomatic implants present an optimized design with adapted treatment protocol, allowing for treatment of patien...
Eligibility Criteria
Inclusion
- 18 years of age or more;
- Opposing dentition (natural teeth or teeth/implant-supported fixed restorations).
Exclusion
- Symptomatology related to the facial sinuses (maxillary sinusitis, polyps or any other sinus pathologies);
- Unfavorable maxillary relations;
- Signs of allergy or hypersensitivity to the chemical ingredients of the material: titanium;
- Presence of acute inflammatory or infectious processes in live tissue;
- Unsuitable bone volume and/or quality;
- Systemic complications or diseases such as bone metabolism disorders, blood clotting disorders, unsuitable healing capacity, incomplete jawbone growth, uncooperative and not motivated patient, 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, endocrine diseases, insufficient oral hygiene, and pregnancy.
- Additionally, subjects will be excluded if they present systemic complications that may expose them to an eventual surgical risk if submitted to surgery under general anesthesia or under local anesthesia and sedation (decompensated diabetics, immunosuppressed, patients who were submitted to radiotherapy and chemotherapy less than 4 years or who had a heart attack less than 1 year previously, patients with clinical signs and/or symptoms of sinusitis and congestion and/or nasal secretion.
Key Trial Info
Start Date :
July 15 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 1 2024
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT04328116
Start Date
July 15 2020
End Date
March 1 2024
Last Update
November 9 2023
Active Locations (1)
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1
Instituto Latino Americano de Pesquisa e Ensino Odontológico
Curitiba, Paraná, Brazil, 80710-150