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OpenTrials
Completed

NCT Number: NCT00641277

Longitudinal Efficacy of Dental Implants in Anterior Areas

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.

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Key information

Age range

15 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Alabama at Birmingham School of Dentistry

Birmingham, Alabama, 35294 0007, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. peri-implant bone support

    Time frame: 5 years following prosthetic attachment

Secondary outcomes

  1. Aesthetics and function

    Time frame: 5 years following prosthectic attachment

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Collaborators

  • BioHorizons, Inc.

Registry information

Official study title

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

Acronym: Maximus

Important dates

Study start
2004
Primary completion
2010
Study completion
2010
First posted
Mar 24, 2008
Registry last updated
Mar 1, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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