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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00723944
Other study ID # 2302
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 2005
Est. completion date May 2011

Study information

Verified date March 2022
Source ZimVie
Contact n/a
Is FDA regulated No
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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