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EdentulismACE-2005NCT00641576

Evaluation of the ACE Dental Implant

An observational study of Edentulism, run by University of Alabama at Birmingham at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 19 to 75 yearsHealthy volunteers can take part
Conditions the study is for
Edentulism
What is being tested?
ACE CONNECT Endosseous dental implant
Type of treatment
Medical device
How many people
23 participants
Where
1 siteUnited States
Study dates
Apr 2005to Sep 2010
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 to 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Dental school periodontology clinic

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Alabama at Birmingham School of Dentistry

    Birmingham, Alabama, 35294 0007

Other trials in United States

About this study

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.

Read more

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.

Read the 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.

Conditions
Edentulism
Being tested
ACE CONNECT Endosseous dental implant
Keywords
Endosseous implants

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ACE CONNECT Endosseous dental implantDevice

    Also called ACE Morse Taper Lock, ACE Implant Internal-Connection

    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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Junctional stability between device and abutment

    Measured: 24 months

Secondary outcomes (2)

  1. Peri-implant osseous support of the device

    Measured: 24 months

  2. Peri-implant soft-tissue response to the device

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Mar 2008 (estimated)
  2. Study startApr 2005
  3. Primary completionSep 2010
  4. Study completionSep 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
23 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00641576
Sponsor's protocol ID
W050404001
Acronym
ACE-2005
Status last verified
Jul 2013
First submitted
17 Mar 2008
Last updated
22 Jul 2013
Results posted
No
Data monitoring committee
No

Publications

  • Zarb GA, Schmitt A. The longitudinal clinical effectiveness of osseointegrated dental implants: the Toronto study. Part III: Problems and complications encountered. J Prosthet Dent. 1990 Aug;64(2):185-94. doi: 10.1016/0022-3913(90)90177-e.

    PubMed 2202818

  • Goodacre CJ, Kan JY, Rungcharassaeng K. Clinical complications of osseointegrated implants. J Prosthet Dent. 1999 May;81(5):537-52. doi: 10.1016/s0022-3913(99)70208-8.

    PubMed 10220658

  • Jemt T, Book K, Linden B, Urde G. Failures and complications in 92 consecutively inserted overdentures supported by Branemark implants in severely resorbed edentulous maxillae: a study from prosthetic treatment to first annual check-up. Int J Oral Maxillofac Implants. 1992 Summer;7(2):162-7.

    PubMed 1398832

  • Naert I, Quirynen M, van Steenberghe D, Darius P. A study of 589 consecutive implants supporting complete fixed prostheses. Part II: Prosthetic aspects. J Prosthet Dent. 1992 Dec;68(6):949-56. doi: 10.1016/0022-3913(92)90557-q.

    PubMed 1494126

  • Kallus T, Bessing C. Loose gold screws frequently occur in full-arch fixed prostheses supported by osseointegrated implants after 5 years. Int J Oral Maxillofac Implants. 1994 Mar-Apr;9(2):169-78.

    PubMed 8206552

  • Jemt T, Laney WR, Harris D, Henry PJ, Krogh PH Jr, Polizzi G, Zarb GA, Herrmann I. Osseointegrated implants for single tooth replacement: a 1-year report from a multicenter prospective study. Int J Oral Maxillofac Implants. 1991 Spring;6(1):29-36.

    PubMed 1843491

  • Becker W, Becker BE. Replacement of maxillary and mandibular molars with single endosseous implant restorations: a retrospective study. J Prosthet Dent. 1995 Jul;74(1):51-5. doi: 10.1016/s0022-3913(05)80229-x.

    PubMed 7674191

  • Lazzara R, Siddiqui AA, Binon P, Feldman SA, Weiner R, Phillips R, Gonshor A. Retrospective multicenter analysis of 3i endosseous dental implants placed over a five-year period. Clin Oral Implants Res. 1996 Mar;7(1):73-83. doi: 10.1034/j.1600-0501.1996.070109.x.

    PubMed 9002825

  • Binon PP. Evaluation of the effectiveness of a technique to prevent screw loosening. J Prosthet Dent. 1998 Apr;79(4):430-2. doi: 10.1016/s0022-3913(98)70157-x.

    PubMed 9576318

  • McGlumphy EA, Mendel DA, Holloway JA. Implant screw mechanics. Dent Clin North Am. 1998 Jan;42(1):71-89.

    PubMed 9421671

  • Hurson S. Laboratory techniques to prevent screw loosening on dental implants. J Dent Technol. 1996 Apr;13(3):30-7.

    PubMed 9516271

  • Bragger U, Hafeli U, Huber B, Hammerle CH, Lang NP. Evaluation of postsurgical crestal bone levels adjacent to non-submerged dental implants. Clin Oral Implants Res. 1998 Aug;9(4):218-24. doi: 10.1034/j.1600-0501.1998.090402.x.

    PubMed 9760896

  • Weber HP, Buser D, Fiorellini JP, Williams RC. Radiographic evaluation of crestal bone levels adjacent to nonsubmerged titanium implants. Clin Oral Implants Res. 1992 Dec;3(4):181-8. doi: 10.1034/j.1600-0501.1992.030405.x.

    PubMed 1298433

  • 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

Questions about this trial

What is this clinical trial studying?

An observational study of Edentulism, run by University of Alabama at Birmingham at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Junctional stability between device and abutment (time frame: 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00641576, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2013.

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