Text Size

Observational Study of Osseotite Certain Tapered Implants in Immediate Loading Cases (Carrera)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Biomet, Inc.
ClinicalTrials.gov Identifier:
NCT01529762
First received: February 7, 2012
Last updated: March 20, 2013
Last verified: March 2013
History of Changes
  Purpose

Osseotite Certain Tapered implants placed in immediate prosthesis loaded cases.


Condition
Partial Edentulism
Tooth Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective, Observational Study of Immediate Loading Cases Using Osseotite Certain Tapered Implants

Resource links provided by NLM:

MedlinePlus related topics: Tooth Disorders
U.S. FDA Resources

Further study details as provided by Biomet, Inc.:

Primary Outcome Measures:
  • cumulative success rate [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    An implant will be considered successful if it is immobile at various study points in time


Enrollment: 47
Study Start Date: January 2011
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Osseotite Certain Tapered
Dental implant Osseotite Certain Tapered design

Detailed Description:

Osseotite Certain Tapered implants are placed and restored immediately (during the same visit)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients with partial edentulism needing a minimum of one dental implant restored immediately (same visit)

Criteria

Inclusion Criteria:

  • patients of either sex and older than 18 years of age
  • patients needing at least one dental implant to treat partial edentulism
  • patients physically able to tolerate surgical and restorative dental procedures
  • patients agreeing to all protocol visits

Exclusion Criteria:

  • patients with infection or severe inflammation at the intended treatment sites
  • patients smoking greater than 10 cigarettes per day
  • patients with uncontrolled diabetes mellitus
  • patients with uncontrolled metabolic diseases
  • patients who received radiation treatment to the head in the past 12 months
  • patients needing bone grafting at the intended treatment sites
  • patients known to be pregnant at screening visit
  • patients with para-functional habits like bruxing and clenching
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01529762

Locations
Chile
Universidad San Sebastian
Santiago, Chile
Sponsors and Collaborators
Biomet, Inc.
Investigators
Principal Investigator: Fernando Fuentes, DDS Universidad San Sebastian
  More Information

No publications provided

Responsible Party: Biomet, Inc.
ClinicalTrials.gov Identifier: NCT01529762     History of Changes
Other Study ID Numbers: 3007
Study First Received: February 7, 2012
Last Updated: March 20, 2013
Health Authority: Chile: Institutional Review Board

Keywords provided by Biomet, Inc.:
edentulism
dental implants
Osseotite Certain Tapered
randomized
 clinical study
partial edentulism
immediate loading
crestal bone level

Additional relevant MeSH terms:
Tooth Diseases
Stomatognathic Diseases

ClinicalTrials.gov processed this record on May 19, 2013