Osseotite Certain Prevail for the Preservation of Crestal Bone

NCT01611493 | Unknown Phase 3

• 1 other identifier: implantes3i
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Dental Implants; Jaw, Edentulous, Partially/rehabilitation; Jaw, Edentulous, Partially/surgery; randomised Clinical Trials; Humans

Outcome Measures

Primary Outcomes (1)

• Preservation of crestal bone

  Two years

Secondary Outcomes (1)

• Osseus integration

  Two years

Study Arms (2)

Osseotite Prevail Implant

EXPERIMENTAL

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 Non Prevail Implant

ACTIVE COMPARATOR

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

Interventions

Osseotite Prevail Implant DEVICE

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

Osseotite Prevail Implant

Osseotite Non Prevail Implant DEVICE

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

Osseotite Non Prevail Implant

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Andres Duque Duque: lead
• Zimmer Biomet: collaborator

Study Sites (1)

CES University / Faculty of Dentistry

Medellín, Antioquia, 050021, Colombia

RECRUITING

MeSH Terms

Conditions

Jaw, Edentulous, Partially; Mouth, Edentulous

Condition Hierarchy (Ancestors)

Jaw, Edentulous; Jaw Diseases; Musculoskeletal Diseases; Stomatognathic Diseases; Mouth Diseases; Tooth Diseases

Study Officials

• Andres Duque, MSc

  CES University

  PRINCIPAL INVESTIGATOR

• Pablo E Correa, MSc

  CES University

  PRINCIPAL INVESTIGATOR

• Astrid Giraldo, Postgraduate

  CES University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andres Duque, MSc

CONTACT

(0574)444055; aduqued@ces.edu.co

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: May 31, 2012
• First Posted: June 5, 2012
• Study Start: March 1, 2011
• Primary Completion: November 1, 2012
• Study Completion: September 1, 2013
• Last Updated: June 5, 2012

Record last verified: 2012-06

Locations

CO (1)