Clinical trial NCT00641277: Longitudinal Efficacy of Dental Implants in Anterior Areas
Official title: A Study to Evaluate the Efficacy of the 3mm Maximus Dental Implant in Areas of Limited Tooth-to-tooth Spacing
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Edentulous
Keywords: endosseous dental implants
dental aesthetics
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: BioHorizons, Inc.
First posted: 2008-03-24
Enrollment: 15
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Dental clinic

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.

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 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

Primary outcomes:
measure: peri-implant bone support
timeFrame: 5 years following prosthetic attachment
Secondary outcomes:
measure: Aesthetics and function
timeFrame: 5 years following prosthectic attachment
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham School of Dentistry
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Michael S Reddy, DMD, DMSc
role: PRINCIPAL_INVESTIGATOR
References:
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