Implant Retained Rehabilitation With Surgical and Prosthetic Digital Workflow
Jaw, Edentulous, Partially
About this trial
This is an interventional treatment trial for Jaw, Edentulous, Partially focused on measuring Dental Implants, Bone-Implant Interface, Mouth Rehabilitation
Eligibility Criteria
Inclusion Criteria:
- 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 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 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.
Sites / Locations
- Instituto Latino Americano de Pesquisa e Ensino Odontológico (ILAPEO)
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Abutment removal
Final abutment
At the time of surgery, customizable healing abutments will be placed on implants. These will be replaced by Pro PEEK Abutments 21 days later to placement of temporary prostheses (loading). The final abutments (Titanium Bases) and final prostheses will be inserted 2 months after loading.
The final abutments (Titanium Bases) will be placed at the time of the implant placement surgery and will stay at mouth during all period of the study. Temporary and final prosthesis will be placed on Titanium Bases.