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

June 1, 2012 updated by: Andres Duque Duque

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Colombia
    • Antioquia
      • Medellín, Antioquia, Colombia, 050021
        • Recruiting
        • CES University / Faculty of Dentistry
        • Contact:
        • Principal Investigator:
          • Andres Duque, MSc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Preservation of crestal bone
Time Frame: Two years
Two years

Secondary Outcome Measures

Outcome Measure
Time Frame
Osseus integration
Time Frame: Two years
Two years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Andres Duque Duque

Collaborators

Zimmer Biomet

Investigators

  • Principal Investigator: Andres Duque, MSc, CES University
  • Principal Investigator: Pablo E Correa, MSc, CES University
  • Principal Investigator: Astrid Giraldo, Postgraduate, CES University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2011

Primary Completion (Anticipated)

November 1, 2012

Study Completion (Anticipated)

September 1, 2013

Study Registration Dates

First Submitted

May 31, 2012

First Submitted That Met QC Criteria

June 1, 2012

First Posted (Estimate)

June 5, 2012

Study Record Updates

Last Update Posted (Estimate)

June 5, 2012

Last Update Submitted That Met QC Criteria

June 1, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • implantes3i

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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