Evaluation of the ACE Dental Implant (ACE-2005)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00641576
Recruitment Status : Completed
First Posted : March 24, 2008
Last Update Posted : July 22, 2013
ACE Surgical Supply, Inc.
Information provided by (Responsible Party):
Michael Reddy, DMD, University of Alabama at Birmingham

Brief 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.

Condition or disease Intervention/treatment
Edentulism Device: ACE CONNECT Endosseous dental implant

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.

Study Type : Observational
Actual Enrollment : 23 participants
Observational Model: Case-Only
Time Perspective: Prospective
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
Study Start Date : April 2005
Actual Primary Completion Date : September 2010
Actual Study Completion Date : September 2010

Intervention Details:
    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.

    Other Names:
    • ACE Morse Taper Lock
    • ACE Implant Internal-Connection

Primary Outcome Measures :
  1. Junctional stability between device and abutment [ Time Frame: 24 months ]

Secondary Outcome Measures :
  1. Peri-implant osseous support of the device [ Time Frame: 24 months ]
  2. Peri-implant soft-tissue response to the device [ Time Frame: 24 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Dental school periodontology clinic

Inclusion Criteria:

  • Need for replacement of non-adjacent missing teeth with dental implants
  • Edentulous in the area for more than 2 months
  • Minimum native bone height and width to receive a 10mm X 4mm implant

Exclusion Criteria:

  • Untreated decay or periodontal disease in residual dentition
  • Need for bone or soft-tissue augmentation in the proposed implant site
  • Pregnancy
  • Consistent use of medications likely to compromise bone healing
  • Chronic disease condition likely to compromise bone healing
  • Consistent smoking over 10 cigarettes during the immediate past 6 months

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00641576

United States, Alabama
University of Alabama at Birmingham School of Dentistry
Birmingham, Alabama, United States, 35294 0007
Sponsors and Collaborators
University of Alabama at Birmingham
ACE Surgical Supply, Inc.
Principal Investigator: Michael S Reddy, DMD, DMSc University of Alabama at Birmingham

Lekholm U, Zarb G. Patient selection and preparation. In Branemark P-I, Zarb GA and Albrektsson T. eds. Tissue Integrated Prosthesis: Osseointegration in Clincal Dentistry. Chicago: Quintessence 1985 pp 199-209

Responsible Party: Michael Reddy, DMD, Interin Dean, University of Alabama at Birmingham Identifier: NCT00641576     History of Changes
Other Study ID Numbers: W050404001
First Posted: March 24, 2008    Key Record Dates
Last Update Posted: July 22, 2013
Last Verified: July 2013

Keywords provided by Michael Reddy, DMD, University of Alabama at Birmingham:
Endosseous implants