Study to Evaluate an Implant With a Sloped Top in Patients With a Sloped Jaw Bone
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|ClinicalTrials.gov Identifier: NCT00807456|
Recruitment Status : Completed
First Posted : December 12, 2008
Results First Posted : May 30, 2016
Last Update Posted : May 30, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Edentulism||Device: ASTRA TECH Implant System, OsseoSpeed™||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||65 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||November 2008|
|Actual Primary Completion Date :||June 2013|
|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.
- Bone Level Changes at the Lingual Aspect From Implant Placement (Baseline) to 16 Weeks After Implant Placement [ Time Frame: At baseline and 16 weeks ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|