Maximus: Longitudinal Efficacy of Dental Implants in Anterior Areas

Sponsor
University of Alabama at Birmingham (Other)
Overall Status
Completed
CT.gov ID
NCT00641277
Collaborator
BioHorizons, Inc. (Industry)
15
1
76
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Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Actual Enrollment :
    15 participants
    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
    Study Start Date :
    Mar 1, 2004
    Actual Primary Completion Date :
    Jul 1, 2010
    Actual Study Completion Date :
    Jul 1, 2010

    Outcome Measures

    Primary Outcome Measures

    1. peri-implant bone support [5 years following prosthetic attachment]

    Secondary Outcome Measures

    1. Aesthetics and function [5 years following prosthectic attachment]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    15 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Locations

    Site City State Country Postal Code
    1 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Michael Reddy, DMD, Dean, School of Dentistry, University of Alabama at Birmingham
    ClinicalTrials.gov Identifier:
    NCT00641277
    Other Study ID Numbers:
    • W040218006
    First Posted:
    Mar 24, 2008
    Last Update Posted:
    Mar 1, 2013
    Last Verified:
    Feb 1, 2013
    Keywords provided by Michael Reddy, DMD, Dean, School of Dentistry, University of Alabama at Birmingham
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Mar 1, 2013