Study to Evaluate an Implant With a Sloped Top in Patients With a Sloped Jaw Bone
The study aims to evaluate maintenance of lingual/palatinal marginal bone with the (ASTRA TECH Implant System) OsseoSpeed™ Profile implant in sites where the alveolar crest anatomy is sloped in a lingual to buccal direction.
The hypothesis is that the sloped marginal contour of the implant will help preserve the lingual/palatinal marginal bone.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Prospective, Open, Single Arm, Multi-center Study to Evaluate Maintenance of Lingual Bone in Healed Ridges With the ASTRA TECH Implant System, OsseoSpeed™ Profile Implant. A 3-year Follow-up Study|
- Bone Level Changes at the Lingual Aspect From Implant Placement (Baseline) to 16 Weeks After Implant Placement [ Time Frame: At baseline and 16 weeks ] [ Designated as safety issue: No ]Clinical measurements after implant installation and after 16 weeks to determine bone levels at the buccal and lingual aspects in relation to a fixed landmark on the implant (the rim (R), i.e. the interface between the micro-threaded part and the shoulder at the marginal portion of the implants.The assessments were made using a periodontal probe and distances were measured to the nearest 0.5 mm. Negative value denotes loss of bone.
|Study Start Date:||November 2008|
|Primary Completion Date:||June 2013 (Final data collection date for primary outcome measure)|
|Experimental: ASTRA TECH Implant System, OsseoSpeed™||
Device: ASTRA TECH Implant System, OsseoSpeed™
ASTRA TECH Implant System, OsseoSpeed™ Profile implants: Ø4.5, 5.0, 5.0S mm in lengths of 9, 11, 13, 15mm.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00807456
|United States, Florida|
|Department of Periodontology, College of Dental Medicine, Nova Southeastern University|
|Fort Lauderdale, Florida, United States, 33328-2018|
|United States, Pennsylvania|
|Department of Periodontics, Robert Schattner Center, School of Dental Medicine, University of Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19104|
|Medizinische Hochschule Hannover|
|Hannover, Germany, D-30625|
|Praxis Dr Robert Nölken|
|Lindau, Germany, D-88131|
|Studio Dentistico Donati|
|Perugia, Italy, IT-06121|
|Study Chair:||Tord Berglundh, Prof.||Department of Periodontology, Sahlgrenska Academy at University of Gothenburg|