Edentulism Clinical Trial
Official title:
A Study to Evaluate the Morse Taper Lock and Connection of the ACE Implant Internal-Connection and Its Effect of the Biological Gap
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.
While the external hex dental implant design has had very good clinical success, it is
limited by retention screw loosening at the junction of the implant fixture and abutment; a
situation that leads to micro-movement between components.
A number of clinical complications may arise when implant components separate.
Micro-movement between the implant abutment and seating platform is thought to contribute to
the formation of a "biological gap", the most notable consequence being gradual resorption
of crestal alveolar bone over time.
We hypothesize that the "ACE CONNECT" two-piece implant design with an internal connection
will limit screw loosening by providing a stable junction between the body of the implant
and the abutment; a more stable junction will limit micro-movement and prevent the formation
of a gap between components. Limiting the gap will lead to less inflammation of peri-implant
soft tissues and reduced resorption of bone adjacent to the implant.
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Observational Model: Case-Only, Time Perspective: Prospective
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