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Evaluation of the ACE Dental Implant (ACE-2005)

This study has been completed.
Sponsor:
Collaborator:
ACE Surgical Supply, Inc.
Information provided by (Responsible Party):
Michael Reddy, DMD, University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT00641576
First received: March 17, 2008
Last updated: July 18, 2013
Last verified: July 2013
  Purpose

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 Intervention
Edentulism
Device: ACE CONNECT Endosseous dental implant

Study Type: Observational
Study Design: 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

Further study details as provided by University of Alabama at Birmingham:

Primary Outcome Measures:
  • Junctional stability between device and abutment [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Peri-implant osseous support of the device [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Peri-implant soft-tissue response to the device [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Enrollment: 23
Study Start Date: April 2005
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
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
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.

  Eligibility

Ages Eligible for Study:   19 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Dental school periodontology clinic

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00641576

Locations
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.
Investigators
Principal Investigator: Michael S Reddy, DMD, DMSc University of Alabama at Birmingham
  More Information

Publications:
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
ClinicalTrials.gov Identifier: NCT00641576     History of Changes
Other Study ID Numbers: W050404001
Study First Received: March 17, 2008
Last Updated: July 18, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Alabama at Birmingham:
Endosseous implants

ClinicalTrials.gov processed this record on November 20, 2014