NCT00726063

Brief Summary

This study will evaluate the contributions of the Nanotite implant design when used by graduate students in their first year of placing implants.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
241

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2008

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 29, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 31, 2008

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

February 12, 2014

Completed
Last Updated

March 28, 2022

Status Verified

March 1, 2022

Enrollment Period

4.5 years

First QC Date

July 29, 2008

Results QC Date

November 19, 2013

Last Update Submit

March 24, 2022

Conditions

Tooth DiseasePartial Edentulism

Keywords

dental implantsNanotite implantOsseotite implantsmulticenterrandomizedclinical studypartial edentulismprosthesis

Outcome Measures

Primary Outcomes (1)

  • Integration Success of the Implant

    1 year

Study Arms (2)

Nanotite implant

EXPERIMENTAL

Nanotite dental implant

Device: Nanotite dental implant

Osseotite implant

ACTIVE COMPARATOR

Osseotite dental implant

Device: Osseotite dental implant

Interventions

Nanotite dental implantDEVICE

Nanotite root form titanium dental implant

Also known as: Nanotite endosseous dental implant
Nanotite implant
Osseotite dental implantDEVICE

Osseotite Root form titanium dental implant

Also known as: Osseotite endosseous dental implant
Osseotite implant

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients of either sex and of any race, 18 years of age or older
  • patients for whom a decision has already been made to use dental implants for treating edentulism in the mandible or maxilla

You may not qualify if:

  • patients who are known to be pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Alabama Birmingham

Birmingham, Alabama, 35294, United States

Location

MeSH Terms

Conditions

Tooth Diseases

Condition Hierarchy (Ancestors)

Stomatognathic Diseases

Results Point of Contact

Title
Clinical Research Manager
Organization
Biomet 3i LLC
cristina.matthews@biomet.com
5617766722

Study Officials

  • Michael S Reddy, DMD

    University of Alabama at Birmingham

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: implant types were randomized- 2 different surface treatments
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 29, 2008

First Posted

July 31, 2008

Study Start

April 1, 2008

Primary Completion

October 1, 2012

Study Completion

October 1, 2012

Last Updated

March 28, 2022

Results First Posted

February 12, 2014

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)