NCT00641277

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2004

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2004

Completed
4 years until next milestone

First Submitted

Initial submission to the registry

March 17, 2008

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 24, 2008

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2010

Completed
Last Updated

March 1, 2013

Status Verified

February 1, 2013

Enrollment Period

6.3 years

First QC Date

March 17, 2008

Last Update Submit

February 27, 2013

Conditions

Edentulous

Keywords

endosseous dental implantsdental aesthetics

Outcome Measures

Primary Outcomes (1)

  • peri-implant bone support

    5 years following prosthetic attachment

Secondary Outcomes (1)

  • Aesthetics and function

    5 years following prosthectic attachment

Eligibility Criteria

Age15 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Dental clinic

You may qualify if:

  • Missing anterior teeth

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Alabama at Birmingham School of Dentistry

Birmingham, Alabama, 35294 0007, United States

Location

Related Publications (9)

  • 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.

    PMID: 4924041BACKGROUND

  • 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.

    PMID: 6809663BACKGROUND

  • 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.

    PMID: 2094653BACKGROUND

  • 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.

    PMID: 3290429BACKGROUND

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

    PMID: 8054223BACKGROUND

  • 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.

    PMID: 3075194BACKGROUND

  • 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.

    PMID: 2700745BACKGROUND

  • 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.

    PMID: 9586460BACKGROUND

  • 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.

    PMID: 1450160BACKGROUND

MeSH Terms

Conditions

Mouth, Edentulous

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic DiseasesTooth Diseases

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
Dean, School of Dentistry

Study Record Dates

First Submitted

March 17, 2008

First Posted

March 24, 2008

Study Start

March 1, 2004

Primary Completion

July 1, 2010

Study Completion

July 1, 2010

Last Updated

March 1, 2013

Record last verified: 2013-02

Locations

US(1)