Study to Compare Marginal Bone Loss Around Implants From Two Dental Implant Systems.
Completed · Not applicable
Conditions studied: Jaw, Edentulous, Partially
In brief
The purpose of this study is to compare marginal bone level changes between ASTRA TECH Implant System; Fixture ST and Biomet 3i; Osseotite® Implants. Subjects with partial edentulism in the posterior maxilla and/or mandible will be included and a one-stage surgical protocol will be used. Implants will be loaded within 15 weeks from installation. The subjects will be followed for 3 years.
Key facts
- Study ID
- NCT00746187
- Run by
- Dentsply Sirona Implants and Consumables
- People needed
- 36
- Starts
- 2002-12-01
- Expected to finish
- 2011-06-01
- Last updated by the study team
- 2016-04-13
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Provision of written informed consent
- Age 18 - 75 years
- Partial edentulism, Kennedy class I or II, last natural tooth must be cuspid or first bicuspid
- Edentulous in the area/s if implant placement for more than 2 months
You may not qualify if…
- Untreated caries and/or periodontal disease of residual dentition
- Need for pre-surgical bone or soft tissue augmentation in the planned implant area/s.
- Absence of occlusal stability in centric occlusion
- Any systemic or local disease or condition that would compromise post-operative healing and/or osseointegration
- Systemic corticosteroids or any other medication that would compromise post-operative healing and/or osseointegration
- Pregnancy
- Present alcohol or drug abuse
- Tobacco smoking during the last 6 months
- Unable or unwilling to return for follow-up visits for a period of 3 years
Where it is running
- Dept. of Implant Dentistry, New York University — New York, New York, United States
- Dept. of Prosthodontics, School of Dentistry, University of North Carolina — Chapel Hill, North Carolina, United States
Full record on ClinicalTrials.gov
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