Longitudinal Efficacy of Dental Implants in Anterior Areas

NCT ID: NCT00641277

Last Updated: 2013-03-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

15 participants

Study Classification

OBSERVATIONAL

Study Start Date

2004-03-31

Study Completion Date

2010-07-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Edentulous

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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BioHorizons, Inc.

INDUSTRY

Sponsor Role collaborator

University of Alabama at Birmingham

OTHER

Sponsor Role lead

Responsible Party

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Michael Reddy, DMD

Dean, School of Dentistry

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Michael S Reddy, DMD, DMSc

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

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University of Alabama at Birmingham School of Dentistry

Birmingham, Alabama, United States

Site Status

Countries

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United States

References

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Branemark PI, Adell R, Breine U, Hansson BO, Lindstrom J, Ohlsson A. Intra-osseous anchorage of dental prostheses. I. Experimental studies. Scand J Plast Reconstr Surg. 1969;3(2):81-100. doi: 10.3109/02844316909036699. No abstract available.

Reference Type BACKGROUND
PMID: 4924041 (View on PubMed)

Adell R, Lekholm U, Rockler B, Branemark 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. doi: 10.1016/s0300-9785(81)80077-4.

Reference Type BACKGROUND
PMID: 6809663 (View on PubMed)

Adell R, Eriksson B, Lekholm U, Branemark 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.

Reference Type BACKGROUND
PMID: 2094653 (View on PubMed)

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. doi: 10.1902/jop.1988.59.5.287.

Reference Type BACKGROUND
PMID: 3290429 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 8054223 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 3075194 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 2700745 (View on PubMed)

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. doi: 10.1034/j.1600-0501.1997.080302.x.

Reference Type BACKGROUND
PMID: 9586460 (View on PubMed)

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. doi: 10.1016/0266-4356(92)90204-v.

Reference Type BACKGROUND
PMID: 1450160 (View on PubMed)

Other Identifiers

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W040218006

Identifier Type: -

Identifier Source: org_study_id

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