NCT03917927

A Clinical Study of the Eztetic Dental Implant System

A Prospective Multicenter Study of the Integration Success of the Eztetic Dental Implant System in Immediate Loading Cases

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 82 (actual)
• Sponsor: ZimVie · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This will be a prospective, observational multicenter study. All implants will be placed in the anterior maxilla or mandible and immediately loaded with a provisional prosthesis out of occlusion. Final restorations insertion will take place no later than 6 months following implant placement surgery. All implants will be restored with a single crown or splinted to a pre-existing implant if in the pre-molar region (no 2 adjacent edentulous sites).

Detailed description

This will be a prospective, observational study in which patients in need of dental implants in the anterior regions of the maxilla or mandible will be treated with the Eztetic dental implant(s). Qualified patients will be those with one or more edentulous area in the anterior maxilla or mandible needing a single (restored as a single crown; if in the pre-molar region, it is recommended implant be splinted to another tooth or implant; no 2 adjacent edentulous sites). Qualified patients should have presence of posterior teeth or a stable posterior occlusion. All implants will be placed in a single-stage manner. A provisional abutment will be placed and a temporary crown will be placed (cemented or screw-retained) out of occlusion at implant placement surgery visit. Impressions for permanent prosthesis fabrication will take place at 6 weeks and prosthesis placement will take place at 2 months. Final prosthesis insertion will take place no later than 6 months following implant placement surgery. Resonance frequency assessment procedures will be done at implant placement surgery and at prosthesis insertion. Implant survival will be the primary study endpoint. Crestal bone regression will be the secondary study endpoint. Enrollment will continue until 20 patients have completed final prosthetic treatment at study center.

Conditions

• Edentulous Jaw

Interventions

Type	Name	Description
DEVICE	Eztetic dental implant	narrow diameter dental implant

Timeline

• Start date: 2019-01-08
• Primary completion: 2023-05-30
• Completion: 2024-01-22
• First posted: 2019-04-17
• Last updated: 2024-01-25

Locations

4 sites across 3 countries: United States, Chile, Germany

Regulatory

• FDA-regulated device study