Evaluation of the ACE Dental Implant
Condition: Edentulism
Study type: Observational

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.
    

Detailed description: 
      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.
    

Intervention name(s): ACE CONNECT Endosseous dental implant
Intervention type(s): Device
Intervention description(s): 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.
Other intervention name(s): ACE Morse Taper Lock; ACE Implant Internal-Connection
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Dental school periodontology clinic
      
Keywords: Endosseous implants