NCT00723944

A Study of the Performance of Certain Prevail Implants Used in Short Fixed Cases

A Prospective, Randomized-controlled Multicenter Study of the Osseotite Certain Lateralized Implanting Short-span Fixed Bridge Cases for Preservation of Crestal Bone

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 102 (actual)
• Sponsor: ZimVie · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This prospective, randomized study evaluates the performance and crestal bone changes difference between the Osseotite Certain Prevail vs the non-lateralized design of the implant. Study (null) hypothesis: the crestal bone changes that take place after placement and loading of the Osseotite lateralized implants will be the same as for similar but non-lateralized Osseotite Certain implants.

Detailed description

This is a prospective, randomized-controlled study where patients with qualifying partial edentulism received a short fixed bridge restoration. Each implant site was randomized to receive either the test (Osseotite Certain Prevail) or the control non lateralized version of the Osseotite Certain implant. All implants were placed in a single-stage manner with temporary provisionalization taking place two months after implant placement. Enrollment continued until 10 patients (approximately 30 implants) were treated at each participating study center.

Conditions

• Partial Edentulism
• Tooth Disease

Interventions

Type	Name	Description
DEVICE	Osseotite Certain Prevail	Root form titanium dental implant
DEVICE	Osseotite Certain	Dental implant without the lateralized design

Timeline

• Start date: 2005-02-01
• Primary completion: 2007-04-01
• Completion: 2011-05-01
• First posted: 2008-07-29
• Last updated: 2022-04-19
• Results posted: 2011-11-22

Locations

1 site across 1 country: Germany