Evaluation of the ACE Dental Implant
NCT00641576 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 23
Last updated 2013-07-22
Summary
Dental implants are small metal posts that look like miniature screws. They are surgically implanted into the jawbone where they serve as substitute tooth roots. Implants are used in dentistry to reestablish function and aesthetics to areas of the mouth were natural teeth are missing.
Classical dental implants are made in two pieces. One part anchors in the jawbone and one part serves as a connecting post (an abutment) that attaches to a crown restoration or to attachment clasps that hold a denture in place.
Occasionally the materials used to fasten the two implant components together work their way loose and over time the abutment may begin to disconnect. If this happens a small gap appears between the implant and abutment. There are many reasons why this loosening occurs. One reason may be the design of the implant itself and another may be the way the two components are fastened together.
This study will assess the performance of an implant with a new design. The investigators hypothesize that using this implant design will reduce the risk of an implant-abutment disconnect and improve long-term success of implant therapy.
Conditions
- Edentulism
Interventions
- DEVICE
-
ACE CONNECT Endosseous dental implant
Subjects in this study receive ACE CONNECT Internal-Connection dental implants to: 1)replace a missing tooth in an edentulous area of the maxilla or mandible restored with a single-unit crown (may include up to two non-adjacent areas as study sites) or, 2)subjects with an edentulous mandible will receive two implants placed in the lower canine position and restored with an implant-retained removable over-denture. Subjects will return for four follow-up evaluations scheduled at 6, 12, 18 and 24 months after delivery of the permanent restoration.
Sponsors & Collaborators
-
ACE Surgical Supply, Inc.
collaborator INDUSTRY -
University of Alabama at Birmingham
lead OTHER
Principal Investigators
-
Michael S Reddy, DMD, DMSc · University of Alabama at Birmingham
Eligibility
- Min Age
- 19 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2005-04-30
- Primary Completion
- 2010-09-30
- Completion
- 2010-09-30
Countries
- United States
Study Locations
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