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Osseotite Certain Prevail for the Preservation of Crestal Bone

NCT01611493 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2012-06-05

No results posted yet for this study

Summary

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.

Conditions

  • Jaw, Edentulous, Partially

Interventions

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

Sponsors & Collaborators

  • Zimmer Biomet

    collaborator INDUSTRY

  • Andres Duque Duque

    lead OTHER

Principal Investigators

  • Andres Duque, MSc · CES University

  • Pablo E Correa, MSc · CES University

  • Astrid Giraldo, Postgraduate · CES University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-03-31
Primary Completion
2012-11-30
Completion
2013-09-30

Countries

  • Colombia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01611493 on ClinicalTrials.gov