Longitudinal Efficacy of Dental Implants in Anterior Areas (Maximus)

This study has been completed.
Sponsor:
Collaborator:
BioHorizons, Inc.
Information provided by (Responsible Party):
Michael Reddy, DMD, University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT00641277
First received: March 17, 2008
Last updated: February 27, 2013
Last verified: February 2013
  Purpose

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
Edentulous

Study Type: Observational
Study Design: 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

Further study details as provided by University of Alabama at Birmingham:

Primary Outcome Measures:
  • peri-implant bone support [ Time Frame: 5 years following prosthetic attachment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Aesthetics and function [ Time Frame: 5 years following prosthectic attachment ] [ Designated as safety issue: No ]

Enrollment: 15
Study Start Date: March 2004
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   15 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Dental clinic

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00641277

Locations
United States, Alabama
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
  More Information

Publications:

Responsible Party: Michael Reddy, DMD, Dean, School of Dentistry, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT00641277     History of Changes
Other Study ID Numbers: W040218006
Study First Received: March 17, 2008
Last Updated: February 27, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Alabama at Birmingham:
endosseous dental implants
dental aesthetics

ClinicalTrials.gov processed this record on October 19, 2014