Longitudinal Efficacy of Dental Implants in Anterior Areas

Edentulous Clinical Trial

— Maximus  

Official title:

A Study to Evaluate the Efficacy of the 3mm Maximus Dental Implant in Areas of Limited Tooth-to-tooth Spacing

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00641277
• Other study ID #: W040218006
• Status: Completed
• Phase: N/A
• First received: March 17, 2008
• Last updated: February 27, 2013
• Start date: March 2004
• Est. completion date: July 2010

Study information

• Verified date: February 2013
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: July 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 15 Years and older

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Edentulous

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham School of Dentistry	Birmingham	Alabama

Sponsors (2)

Lead Sponsor	Collaborator
University of Alabama at Birmingham	BioHorizons, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (9)

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. — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	peri-implant bone support		5 years following prosthetic attachment	No
Secondary	Aesthetics and function		5 years following prosthectic attachment	No