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OpenTrials
Completed

NCT Number: NCT00641576

Evaluation of the ACE Dental Implant

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.

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Key information

Conditions

Age range

19 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Alabama at Birmingham School of Dentistry

Birmingham, Alabama, 35294 0007, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ACE CONNECT Endosseous dental implant

Device

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 outcomes

  1. Junctional stability between device and abutment

    Time frame: 24 months

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Collaborators

  • ACE Surgical Supply, Inc.

Registry information

Official study title

A Study to Evaluate the Morse Taper Lock and Connection of the ACE Implant Internal-Connection and Its Effect of the Biological Gap

Acronym: ACE-2005

Important dates

Study start
2005
Primary completion
2010
Study completion
2010
First posted
Mar 24, 2008
Registry last updated
Jul 22, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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