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

March 17, 2008
February 27, 2013
March 2004
July 2010   (final data collection date for primary outcome measure)
peri-implant bone support [ Time Frame: 5 years following prosthetic attachment ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00641277 on ClinicalTrials.gov Archive Site
Aesthetics and function [ Time Frame: 5 years following prosthectic attachment ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Longitudinal Efficacy of Dental Implants in Anterior Areas
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.

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.

Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Dental clinic

Edentulous
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
15
July 2010
July 2010   (final data collection date for primary outcome measure)

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
Both
15 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00641277
W040218006
No
Michael Reddy, DMD, University of Alabama at Birmingham
University of Alabama at Birmingham
BioHorizons, Inc.
Principal Investigator: Michael S Reddy, DMD, DMSc University of Alabama at Birmingham
University of Alabama at Birmingham
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP