Longitudinal Efficacy of Dental Implants in Anterior Areas | NCT00641277

Studies
Longitudinal Efficacy of Dental Implants in Anterior Areas

NCT00641277

Sponsor

University of Alabama at Birmingham

Status

Completed

Last Update Posted

Mar 1, 2013Estimated

Enrollment

15Actual

Phase

Not provided

Conditions

Edentulous

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2004

Primary Completion Date

Jul 2010Actual

Completion Date

Jul 2010Actual

First Submitted Date

Mar 17, 2008

First Submission Date that Met QC Criteria

Mar 21, 2008

First Posted Date

Mar 24, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 27, 2013

Last Update Posted Date

Mar 1, 2013Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Michael Reddy, DMD, Dean, School of Dentistry, University of Alabama at BirminghamPrincipal Investigator

Lead Sponsor

University of Alabama at BirminghamOTHER

Collaborators

Name	Class
BioHorizons, Inc.	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

15Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
peri-implant bone support		5 years following prosthetic attachment

Secondary Outcomes

Measure	Description	Time Frame
Aesthetics and function		5 years following prosthectic attachment

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

15 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Dental clinic

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Michael S Reddy, DMD, DMSc	University of Alabama at Birmingham	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Alabama at Birmingham School of Dentistry		Birmingham	Alabama	35294 0007	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
4924041	Background	Branemark PI, Adell R, Breine U, Hansson BO, Lindstrom J, Ohlsson A. Intra-osseous anchorage of dental prostheses. I. Experimental studies. Scand J Plast Reconstr Surg. 1969;3(2):81-100. doi: 10.3109/02844316909036699. No abstract available.
6809663	Background	Adell R, Lekholm U, Rockler B, Branemark PI. A 15-year study of osseointegrated implants in the treatment of the edentulous jaw. Int J Oral Surg. 1981 Dec;10(6):387-416. doi: 10.1016/s0300-9785(81)80077-4.

ID	Term
D009059	Mouth Diseases
D009057	Stomatognathic Diseases
D014076	Tooth Diseases