Study to Compare Marginal Bone Loss Around Implants From Two Dental Implant Systems.



Status:Completed
Conditions:Dental
Therapuetic Areas:Dental / Maxillofacial Surgery
Healthy:No
Age Range:18 - 75
Updated:4/21/2016
Start Date:December 2002
End Date:June 2011

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Trial Summary
Trial Overview
Inclusion Criteria

An Open, Randomized Study to Compare Two Dental Implant Systems With Regard to Changes in Marginal Bone Level.

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.


Inclusion Criteria:

- 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

Exclusion Criteria:

- 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
We found this trial at
2
sites
Dept. of Implant Dentistry, New York University
New York, New York 10010
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New York, NY
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Dept. of Prosthodontics, School of Dentistry, University of North Carolina
Chapel Hill, North Carolina 27599
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from
Chapel Hill, NC
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