NCT01030523

Short Implants - An Alternative to Bone Grafting?

Study on ASTRA TECH Implant System, Short Implants (OsseoSpeed™) Compared to Standard Length Implants (OsseoSpeed™) in Combination With Bone Grafting

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 101 (actual)
• Sponsor: Dentsply Sirona Implants and Consumables · Industry
• Sex: All
• Age: 20 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The study, with the ASTRA TECH Implant System, is comparing short implants (OsseoSpeed™) to standard length implants (OsseoSpeed™) in combination with bone grafting. The hypothesis is that the use of short implants in posterior maxilla with inadequate bone is as safe and predictable as placing standard length implants in combination with bone augmentation.

Detailed description

This study was designed as an open, prospective, randomized, controlled, multicenter, 5-year follow-up investigation evaluating the outcome of treatment with the OsseoSpeed™ implant 6 mm placed in the posterior maxilla compared to treatment with OsseoSpeed™ implant 11, 13 or 15 mm placed after bone grafting. The study was during the conduct of the study amended to include a 10-year extension cohort.

Conditions

• Jaw, Edentulous, Partially

Interventions

Type	Name	Description
DEVICE	ASTRA TECH Implant System, OsseoSpeed™ 4.0 S (length: 6 mm)	ASTRA TECH Implant System, OsseoSpeed™ 4.0 S (length: 6 mm)
DEVICE	ASTRA TECH Implant System, OsseoSpeed™ implants (lengths: 11, 13, 15 mm) in combination with bone grafting	ASTRA TECH Implant System, OsseoSpeed™ implants (lengths: 11, 13, 15 mm) in combination with bone grafting

Timeline

• Start date: 2009-10-01
• Primary completion: 2016-12-01
• Completion: 2022-03-22
• First posted: 2009-12-11
• Last updated: 2023-04-06
• Results posted: 2020-09-07

Locations

5 sites across 5 countries: United States, Austria, Poland, Spain, Switzerland

Regulatory

• FDA-regulated device study