Longitudinal Efficacy of Dental Implants in Anterior Areas (Maximus)

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

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.

Study Overview

• Status: Completed
• Conditions: Edentulous

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.

• Study Type: Observational
• Enrollment (Actual): 15

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294 0007
      • University of Alabama at Birmingham School of Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Dental clinic

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
peri-implant bone support	5 years following prosthetic attachment

Secondary Outcome Measures

Outcome Measure	Time Frame
Aesthetics and function	5 years following prosthectic attachment

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham
• Collaborators: BioHorizons, Inc.

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• Albrektsson T. On long-term maintenance of the osseointegrated response. Aust Prosthodont J. 1993;7 Suppl:15-24.
• 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. doi: 10.1034/j.1600-0501.1997.080302.x.
• 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.

Study record dates

Study Major Dates

• Study Start: March 1, 2004
• Primary Completion (Actual): July 1, 2010
• Study Completion (Actual): July 1, 2010

Study Registration Dates

• First Submitted: March 17, 2008
• First Submitted That Met QC Criteria: March 21, 2008
• First Posted (Estimate): March 24, 2008

Study Record Updates

• Last Update Posted (Estimate): March 1, 2013
• Last Update Submitted That Met QC Criteria: February 27, 2013
• Last Verified: February 1, 2013

More Information

Terms related to this study

• Keywords: dental aesthetics; endosseous dental implants
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Mouth Diseases; Tooth Diseases; Mouth, Edentulous
• Other Study ID Numbers: W040218006