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Osseotite Certain Prevail for the Preservation of Crestal Bone (OCPTI)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2012 by Andres Duque Duque, CES University.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01611493
First Posted: June 5, 2012
Last Update Posted: June 5, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Zimmer Biomet
Information provided by (Responsible Party):
Andres Duque Duque, CES University
May 31, 2012
June 5, 2012
June 5, 2012
March 2011
November 2012   (Final data collection date for primary outcome measure)
Preservation of crestal bone [ Time Frame: Two years ]
Same as current
No Changes Posted
Osseus integration [ Time Frame: Two years ]
Same as current
Not Provided
Not Provided
 
Osseotite Certain Prevail for the Preservation of Crestal Bone
A Prospective, Randomized-Controlled Evaluation of the Osseotite CP4 Certain Prevail Tapered Implant for the Preservation of Crestal Bone

A potential complicating factor affecting implants is crestal bone loss. The causes of crestal bone loss are attributed to several factors. Among those hypothesized, proof for one or another cause remains obscure. Clinical documentation suggests that implant design may be a key factor. While the evidence is inconclusive, various authors suggest that it is a result of a combination of effects including (1) limited drilling procedure and restricted second-stage surgery 2, (2) rough implant surface in crestal bone 3, (3) microthread design for implant stiffness 4, (4) loading along a conus versus a flat interface 5, and (5) the absence of a significant microgap 6.

The practice of platform switching (e.g. placing a 4 mm diameter abutment on a 5 mm implant seating surface physically moves the inflammatory cell infiltrate zone away from the crestal bone). The growing body of anecdotal platform switch evidence supports this biological width hypothesis. Here the biological width refers to the height of the dento-gingival attachment apparatus around a normal tooth and is defined as the distance necessary for a healthy existence of bone and soft tissue from the most apical extent of a dental restoration.

To formally test this hypothesis the current study has been designed. The Prevail implant has been made with an integrated medialized seating surface that establishes a platform switching function. This implant moves the implant/abutment interface away from the crestal bone and may therefore reduce the amount of bone loss observed in the standard (non-medialized) Osseotite implant design. The objective of this study is to evaluate crestal bone levels adjacent to the implant reference point from the time of implant placement to a period of two years after loading.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Jaw, Edentulous, Partially
  • Device: Osseotite Prevail Implant
    Osseotite Prevail will be placed in sites with native bone, with at least three months of healing since tooth extraction or four months from bone augmentation grafting procedure
  • Device: Osseotite Non Prevail Implant
    Osseotite Non Prevail Implant will be placed in sites with native bone, with at least three months of healing since tooth extraction or four months from bone augmentation grafting procedure
  • Experimental: Osseotite Prevail Implant
    The Osseotite Prevail will be placed in sites with native bone, with at least three months of healing since tooth extraction or four months from bone augmentation grafting procedure.
    Intervention: Device: Osseotite Prevail Implant
  • Active Comparator: Osseotite Non Prevail Implant
    Osseotite Non Prevail Implant will be placed in sites with native bone, with at least three months of healing since tooth extraction or four months from bone augmentation grafting procedure
    Intervention: Device: Osseotite Non Prevail Implant
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
40
September 2013
November 2012   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients of either sex and any race greater than 18 years of age
  • Patients for whom a decision has already been made to use dental implants for the restoration of existing edentulism in the mandible or maxilla.
  • Patients must be physically able to tolerate conventional surgical and restorative procedures.
  • Patients must agree to be evaluated for each study visit, especially the yearly follow-up visits.

Exclusion Criteria:

  • Patients with active infection or severe inflammation in the areas intended for implant placement.
  • Patients with a > 10 cigarette per day smoking habit.
  • Patients with uncontrolled diabetes mellitus.
  • Patients with uncontrolled metabolic bone disease where there is a diagnosis of the following: Osteomalacia, primary or secondary hyperparathyroidism, renal osteodystrophy, or Paget's disease of bone.
  • Patients with a history of therapeutic radiation to the head
  • Patients in need of bone grafting at the site of the intended study implant for augmentation purposes.
  • Patients who are known to be pregnant at the screening visit.
  • Patients with evidence of severe para-functional habits such as bruxing or clenching
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Colombia
 
 
NCT01611493
implantes3i
No
Not Provided
Not Provided
Andres Duque Duque, CES University
Andres Duque Duque
Zimmer Biomet
Principal Investigator: Andres Duque, MSc CES University
Principal Investigator: Pablo E Correa, MSc CES University
Principal Investigator: Astrid Giraldo, Postgraduate CES University
CES University
June 2012

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