Status:
COMPLETED
Neodent Implantable Devices of GM Line
Lead Sponsor:
Neodent
Conditions:
Jaw, Edentulous
Jaw, Edentulous, Partially
Eligibility:
All Genders
18+ years
Brief Summary
Acqua GM (Grand Morse) Helix implants present an optimized implant design with adapted treatment protocol, allowing for treatment of patients with different bone qualities. The objective of the study...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 18 years of age or older;
- Need of one or more dental implants;
- Qualify for placement of Neodent GM Helix implants.
Exclusion
- 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.
Key Trial Info
Start Date :
February 14 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 28 2023
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT03812276
Start Date
February 14 2019
End Date
January 28 2023
Last Update
February 10 2023
Active Locations (2)
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1
Instituto Latino Americano de Pesquisa e Ensino Odontológico (ILAPEO)
Curitiba, Paraná, Brazil, 80710-150
2
Universidade Positivo
Curitiba, Paraná, Brazil, 81280-330