Longitudinal Efficacy of Dental Implants in Anterior Areas (Maximus)

This study has been completed.

Sponsor:

Collaborator:

BioHorizons, Inc.

Information provided by (Responsible Party):

Michael Reddy, DMD, University of Alabama at Birmingham

ClinicalTrials.gov Identifier:

NCT00641277

First received: March 17, 2008

Last updated: February 27, 2013

Last verified: February 2013

History of Changes

Purpose

Dental implants are used in dentistry to reestablish function and appearance to areas of the mouth where natural teeth are missing. Implants can be a good choice for almost all areas of the mouth except where the space left by missing teeth is too narrow. This is usually the case when front teeth are lost of have been missing since birth.

The Maximus dental implant is the smallest implant made, just 3mm in diameter, and is especially designed to replace missing front teeth and yet be strong enough to function as a natural tooth.

This study will assess the functional success of BioHorizons Maximus one-piece endosseous dental implant.

We hypothesize that placement of the 3mm dental implant in areas of limited tooth-to-tooth spacing will be an efficacious tooth root replacement.

Condition
Edentulous

Study Type:	Observational
Study Design:	Observational Model: Case-Only Time Perspective: Prospective
Official Title:	A Study to Evaluate the Efficacy of the 3mm Maximus Dental Implant in Areas of Limited Tooth-to-tooth Spacing

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

Primary Outcome Measures:

peri-implant bone support [ Time Frame: 5 years following prosthetic attachment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Aesthetics and function [ Time Frame: 5 years following prosthectic attachment ] [ Designated as safety issue: No ]

Enrollment:	15
Study Start Date:	March 2004
Study Completion Date:	July 2010
Primary Completion Date:	July 2010 (Final data collection date for primary outcome measure)

Detailed Description:

When maxillary anterior (upper front)and/or mandibular incisors are congenitally missing or lost due to other causes, the space between adjacent teeth is frequently too narrow to support traditional implant therapy and patients are often advised to fill the space with conventional fixed or removable prosthetic appliances.

The one-piece titanium construction of the Maximus design is believed to retain optimal biomechanical stength while remaining small enough for use in anterior reconstruction thereby allowing access to spaces that were previously beyond the scope of implant dentistry.

Eligibility

Ages Eligible for Study:	15 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

Dental clinic

Criteria

Inclusion Criteria:

Missing anterior teeth

Exclusion Criteria:

Pregnancy
Cigarette smoking
Diabetes Mellitus
Other significant medical conditions or habits likely to compromise bone healing
Chronic use of medications likely to compromise bone healing

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00641277

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

BioHorizons, Inc.

Investigators

Principal Investigator:

Michael S Reddy, DMD, DMSc

University of Alabama at Birmingham

More Information

Publications:

Brånemark PI, Adell R, Breine U, Hansson BO, Lindström J, Ohlsson A. Intra-osseous anchorage of dental prostheses. I. Experimental studies. Scand J Plast Reconstr Surg. 1969;3(2):81-100. No abstract available.

Adell R, Lekholm U, Rockler B, Brånemark PI. A 15-year study of osseointegrated implants in the treatment of the edentulous jaw. Int J Oral Surg. 1981 Dec;10(6):387-416.

Adell R, Eriksson B, Lekholm U, Brånemark PI, Jemt T. Long-term follow-up study of osseointegrated implants in the treatment of totally edentulous jaws. Int J Oral Maxillofac Implants. 1990 Winter;5(4):347-59.

Albrektsson T, Dahl E, Enbom L, Engevall S, Engquist B, Eriksson AR, Feldmann G, Freiberg N, Glantz PO, Kjellman O, et al. Osseointegrated oral implants. A Swedish multicenter study of 8139 consecutively inserted Nobelpharma implants. J Periodontol. 1988 May;59(5):287-96.

Albrektsson T. On long-term maintenance of the osseointegrated response. Aust Prosthodont J. 1993;7 Suppl:15-24. Review.

Engquist B, Bergendal T, Kallus T, Linden U. A retrospective multicenter evaluation of osseointegrated implants supporting overdentures. Int J Oral Maxillofac Implants. 1988 Summer;3(2):129-34. No abstract available.

Jemt T, Lekholm U, Adell R. Osseointegrated implants in the treatment of partially edentulous patients: a preliminary study on 876 consecutively placed fixtures. Int J Oral Maxillofac Implants. 1989 Fall;4(3):211-7.

Buser D, Mericske-Stern R, Bernard JP, Behneke A, Behneke N, Hirt HP, Belser UC, Lang NP. Long-term evaluation of non-submerged ITI implants. Part 1: 8-year life table analysis of a prospective multi-center study with 2359 implants. Clin Oral Implants Res. 1997 Jun;8(3):161-72.

Wedgwood D, Jennings KJ, Critchlow HA, Watkinson AC, Shepherd JP, Frame JW, Laird WR, Quayle AA. Experience with ITI osseointegrated implants at five centres in the UK. Br J Oral Maxillofac Surg. 1992 Dec;30(6):377-81.

Responsible Party:	Michael Reddy, DMD, Dean, School of Dentistry, University of Alabama at Birmingham
ClinicalTrials.gov Identifier:	NCT00641277 History of Changes
Other Study ID Numbers:	W040218006
Study First Received:	March 17, 2008
Last Updated:	February 27, 2013
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Alabama at Birmingham:

endosseous dental implants
dental aesthetics

Additional relevant MeSH terms:

Mouth, Edentulous
Mouth Diseases
Stomatognathic Diseases
Tooth Diseases

ClinicalTrials.gov processed this record on May 21, 2013

To Top