Status:
UNKNOWN
Implant Retained Rehabilitation With Surgical and Prosthetic Digital Workflow
Lead Sponsor:
Neodent
Conditions:
Jaw, Edentulous, Partially
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The aim of this study is to prospectively collect clinical data to confirm the safety and clinical performance of Neodent Titanium Base Abutment and Pro PEEK Abutment in daily dental practice setting,...
Detailed Description
The study protocol was reviewed and approved by an Ethics Committee (EC) in Brazil. Sample size was calculated based on an alpha level of 5% and beta of 20% to detect a mean intergroup difference of ...
Eligibility Criteria
Inclusion
- 18 years of age or older;
- 2 upper posterior teeth missing, with adjacent natural tooth;
- Healed implant sites (at least 4 months post-extraction);
- Qualify for placement of 4.0x10 mm Neodent GM Helix implants;
- Adequate bone height to allow the 2mm subcrestal placement of a 10-mm-long implant.
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 materials: titanium, titanium alloy (Ti6Al4V-ELI) or PEEK (Polyetheretherketone);
- 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 :
September 2 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2023
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT04066309
Start Date
September 2 2019
End Date
December 1 2023
Last Update
November 13 2023
Active Locations (1)
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1
Instituto Latino Americano de Pesquisa e Ensino Odontológico (ILAPEO)
Curitiba, Paraná, Brazil, 80710-150