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 17, 2014
Last verified: March 2014

February 7, 2012
March 17, 2014
January 2011
July 2014   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01529762 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Observational Study of Osseotite Certain Tapered Implants in Immediate Loading Cases
A Prospective, Observational Study of Immediate Loading Cases Using Osseotite Certain Tapered Implants

Osseotite Certain Tapered implants placed in immediate prosthesis loaded cases.

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

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

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

  • Partial Edentulism
  • Tooth Disease
Not Provided
Osseotite Certain Tapered
Dental implant Osseotite Certain Tapered design
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
47
July 2015
July 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Chile
 
NCT01529762
3007
No
Biomet, Inc.
Biomet, Inc.
Not Provided
Principal Investigator: Fernando Fuentes, DDS Universidad San Sebastian
Biomet, Inc.
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP