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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by CES University.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Biomet, Inc.
Information provided by (Responsible Party):
Andres Duque Duque, CES University
ClinicalTrials.gov Identifier:
NCT01611493
First received: May 31, 2012
Last updated: June 1, 2012
Last verified: June 2012
  Purpose

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.


Condition Intervention Phase
Jaw, Edentulous, Partially
Device: Osseotite Prevail Implant
Device: Osseotite Non Prevail Implant
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Prospective, Randomized-Controlled Evaluation of the Osseotite CP4 Certain Prevail Tapered Implant for the Preservation of Crestal Bone

Further study details as provided by CES University:

Primary Outcome Measures:
  • Preservation of crestal bone [ Time Frame: Two years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Osseus integration [ Time Frame: Two years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 40
Study Start Date: March 2011
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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
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
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT01611493

Contacts
Contact: Andres Duque, MSc (0574)444055 ext 1515 aduqued@ces.edu.co

Locations
Colombia
CES University / Faculty of Dentistry Recruiting
Medellín, Antioquia, Colombia, 050021
Contact: Andres Duque, MSc    (0574)4440555 ext 1515    aduqued@ces.edu.co   
Principal Investigator: Andres Duque, MSc         
Sponsors and Collaborators
Andres Duque Duque
Biomet, Inc.
Investigators
Principal Investigator: Andres Duque, MSc CES University
Principal Investigator: Pablo E Correa, MSc CES University
Principal Investigator: Astrid Giraldo, Postgraduate CES University
  More Information

No publications provided

Responsible Party: Andres Duque Duque, Principal investigator, CES University
ClinicalTrials.gov Identifier: NCT01611493     History of Changes
Other Study ID Numbers: implantes3i
Study First Received: May 31, 2012
Last Updated: June 1, 2012
Health Authority: Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos

Keywords provided by CES University:
Dental Implants
Jaw, Edentulous, Partially/rehabilitation
Jaw, Edentulous, Partially/surgery
randomised Clinical Trials
Humans

Additional relevant MeSH terms:
Mouth, Edentulous
Jaw, Edentulous
Mouth Diseases
Stomatognathic Diseases
Tooth Diseases
Jaw Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on October 19, 2014