A Study of the Performance of Certain Prevail Implants Used in Short Fixed Cases

Partial Edentulism Clinical Trial

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Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00723944
• Other study ID #: 2302
• Status: Completed
• Phase: N/A
• Start date: February 2005
• Est. completion date: May 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 evaluates the performance and crestal bone changes difference between the Osseotite Certain Prevail vs the non-lateralized design 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 similar but non-lateralized Osseotite Certain implants.

Description:

This is a prospective, randomized-controlled study where patients with qualifying partial edentulism received a short fixed bridge restoration. Each implant site was randomized to receive either the test (Osseotite Certain Prevail) or the control non lateralized version of the Osseotite Certain implant. All implants were placed in a single-stage manner with temporary provisionalization taking place two months after implant placement. Enrollment continued until 10 patients (approximately 30 implants) were treated at each participating study center.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: May 2011
• Est. primary completion date: April 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 dental condition specifically: a partially edentulous short fixed case of less than 4 implants in the maxilla or mandible; no cantilevers are 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 visit

Exclusion Criteria:

• patients with active infection or severe inflammation in the areas intended for the implants

• patients with more than 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 at 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:
• Osseotite Certain Prevail
Root form titanium dental implant
• Osseotite Certain
Dental implant without the lateralized design

Locations

Country	Name	City	State
Germany	Charite- Universitatsmedizin Berlin	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
ZimVie

Country where clinical trial is conducted

Germany, 

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		4 years