NCT00745121

Study Evaluating ASTRA TECH Implant System, OsseoSpeed™ Implants in the Upper Jaw in Women With Osteoporosis

An Open, Prospective, Non-randomized, Controlled, Multicenter Study to Evaluate Clinical Outcome of the ASTRA TECH Implant System, OsseoSpeed™ Implant in Women Over 60 Years of Age With Osteoporosis/Osteopenia

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 103 (actual)
• Sponsor: Dentsply Sirona Implants and Consumables · Industry
• Sex: Female
• Age: 60 Years
• Healthy volunteers: Not accepted

Summary

The overall objective of the study is to compare treatment with the ASTRA TECH Implant System, OsseoSpeed™ implant in the maxilla of postmenopausal women with and without systemic osteoporosis. The hypothesis is that there will be no difference in marginal bone level alterations between the two groups.

Conditions

• Postmenopausal Osteoporosis
• Osteopenia
• Jaw, Edentulous, Partially

Interventions

Type	Name	Description
DEVICE	OsseoSpeed™	ASTRA TECH Implant System, OsseoSpeed™ implants Ø 3.5, 4, 4.5, 5.0 mm in lengths of 8, 9, 11, 13, 15, 17 and 19 mm

Timeline

• Start date: 2008-07-16
• Primary completion: 2017-11-01
• Completion: 2017-11-15
• First posted: 2008-09-03
• Last updated: 2019-11-26
• Results posted: 2019-11-26

Locations

4 sites across 3 countries: Belgium, Germany, Sweden