Evaluation of the ACE Dental Implant

NCT00641576 | Completed

• 1 other identifier: W050404001
• Study Type: observational
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Edentulism

Keywords

Endosseous implants

Outcome Measures

Primary Outcomes (1)

• Junctional stability between device and abutment

  24 months

Secondary Outcomes (2)

• Peri-implant osseous support of the device

  24 months

• Peri-implant soft-tissue response to the device

  24 months

Interventions

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.

Also known as: ACE Morse Taper Lock, ACE Implant Internal-Connection

Eligibility Criteria

• Age: 19 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Dental school periodontology clinic

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• ACE Surgical Supply, Inc.: collaborator

Study Sites (1)

University of Alabama at Birmingham School of Dentistry

Birmingham, Alabama, 35294 0007, United States

Location

Related Publications (14)

• 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.

  PMID: 2202818 BACKGROUND

• 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.

  PMID: 10220658 BACKGROUND

• 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.

  PMID: 1398832 BACKGROUND

• 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.

  PMID: 1494126 BACKGROUND

• 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.

  PMID: 8206552 BACKGROUND

• 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.

  PMID: 1843491 BACKGROUND

• 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.

  PMID: 7674191 BACKGROUND

• 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.

  PMID: 9002825 BACKGROUND

• 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.

  PMID: 9576318 BACKGROUND

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

  PMID: 9421671 BACKGROUND

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

  PMID: 9516271 BACKGROUND

• 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.

  PMID: 9760896 BACKGROUND

• 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.

  PMID: 1298433 BACKGROUND

• 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

  BACKGROUND

Study Officials

• Michael S Reddy, DMD, DMSc

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Interin Dean

Study Record Dates

• First Submitted: March 17, 2008
• First Posted: March 24, 2008
• Study Start: April 1, 2005
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: July 22, 2013

Record last verified: 2013-07

Locations

US (1)