Osseotite Certain Prevail for the Preservation of Crestal Bone

Jaw, Edentulous, Partially Clinical Trial

— OCPTI  

Official title:

A Prospective, Randomized-Controlled Evaluation of the Osseotite CP4 Certain Prevail Tapered Implant for the Preservation of Crestal Bone

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01611493
• Other study ID #: implantes3i
• Status: Recruiting
• Phase: Phase 3
• First received: May 31, 2012
• Last updated: June 1, 2012
• Start date: March 2011
• Est. completion date: September 2013

Study information

• Verified date: June 2012
• Source: CES University
• Contact: Andres Duque, MSc
• Phone: (0574)444055
• Email: aduqued[@]ces.edu.co
• Is FDA regulated: No
• Health authority: Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: September 2013
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Jaw, Edentulous
• Jaw, Edentulous, Partially
• Mouth, Edentulous

Intervention

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
• 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

Locations

Country	Name	City	State
Colombia	CES University / Faculty of Dentistry	Medellín	Antioquia

Sponsors (2)

Lead Sponsor	Collaborator
Andres Duque Duque	Biomet, Inc.

Country where clinical trial is conducted

Colombia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Preservation of crestal bone		Two years	No
Secondary	Osseus integration		Two years	Yes