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

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Biomet, Inc.
ClinicalTrials.gov Identifier:
First received: February 7, 2012
Last updated: March 22, 2016
Last verified: March 2016
Osseotite Certain Tapered implants placed in immediate prosthesis loaded cases.

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:

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: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Osseotite Certain Tapered
Dental implant Osseotite Certain Tapered design

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

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)

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01529762

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

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 22, 2016
Health Authority: Chile: Institutional Review Board

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

Additional relevant MeSH terms:
Tooth Diseases
Stomatognathic Diseases

ClinicalTrials.gov processed this record on May 26, 2016