NCT02940353

The TREFOIL Concept 5 Year Clinical Investigation

The TREFOIL Concept: A Clinical Investigation in the Mandible on 3 Implants With a Fixed Prefabricated Framework

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 110 (actual)
• Sponsor: Nobel Biocare · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

Summary

Prospective, single cohort, multi-center study evaluating the TREFOIL concept for the treatment of edentulous or patients with failing mandibular dentition over 5 years. 90 patients (15 per centre) will be included. The subject population is at least 18 years old, in need of an implant restored full prosthesis providing sufficient bone in the interforaminal where a fixed restoration on three implants is regarded as an appropriate treatment solution. The components are TREFOIL treatment concept (implants and framework).

Conditions

• Edentulous or Failing Dentition Mandible

Interventions

Type	Name	Description
DEVICE	TREFOIL concept

Timeline

• Start date: 2016-04-01
• Primary completion: 2022-06-01
• Completion: 2022-06-01
• First posted: 2016-10-20
• Last updated: 2023-03-22

Locations

5 sites across 5 countries: United States, Australia, Chile, Italy, Spain