A Study of Certain Prevail Implants Used for the Preservation of Crestal Bone in Short Fixed Bridge Cases.

Partial Edentulism Clinical Trial

— Cliffhanger  

Official title:

A Prospective, Randomized-controlled Multicenter Study of the Osseotite Certain Lateralized Implant in Short-span Fixed Bridge Cases for Preservation of Crestal Bone

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00728754
• Other study ID #: 2301
• Status: Completed
• Phase: N/A
• Start date: March 2005
• Est. completion date: April 2011

Study information

• Verified date: March 2022
• Source: ZimVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This prospective, randomized study will evaluate the performance of the Osseotite Certain Prevail implant when compared to that of the non-lateralized version of the implant. Study (null) hypothesis: the crestal bone changes that take place after placement and loading of the Osseotite lateralized implants will be the same as for a similar but non-lateralized Osseotite Certain implant.

Description:

This is a prospective, randomized, longitudinal study in which qualified patients with partial edentulism will receive a short-fixed bridge restoration. Each implant site is randomized to receive either the Osseotite Certain Lateralized (test) or the Osseotite Certain Non-lateralized (control). All implants will receive a temporary prosthesis after two months of placement. Enrollment will include up to 20 patients (approximately 60 implants per center) at each participating study center.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: April 2011
• Est. primary completion date: July 2007
• Accepts healthy volunteers: No
• Gender: All
• 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 treating an existing condition specifically: A partially edentulous short-span fixed case of less than 4 implants in the maxilla or mandible; the prosthesis may be anterior, posterior, or transitionally anterior-posterior; no cantilevers allowed but one interior crown may be a pontic
• 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 metabolic bone disease
• patients who have had treatment with therapeutic radiation to the head within the past 12 months
• patients in need of allogenic bone grafting a the site of the intended study implant
• patients who are pregnant at the screening visit
• patients with evidence of severe para-functional habits such as bruxing or clenching
• patients with cantilevers and more than one pontic per bridge

Related Conditions & MeSH terms

• Partial Edentulism
• Tooth Disease
• Tooth Diseases

Intervention

Device:
• Dental implant Osseotite Prevail
Root form titanium dental implant
• Dental implant Osseotite
root form titanium dental implant

Locations

Country	Name	City	State
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
ZimVie

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Crestal Bone Regression (Amount of Bone Measured) Around Each Implant Unit	Millimeters of crestal bone observed and measured in a radiograph of each study implant is measured and averaged to obtain the mean crestal bone loss or gain for each implant unit.	1 year
Secondary	Osseous Integration		four years