A Prospective Study Evaluating the Performance of Nanotite Osseotite Implants When Placed by Graduate Student Programs (CollegeBowl)

ZimVie

Status: Completed

Conditions: Tooth Disease; Partial Edentulism

Treatments: Device: Nanotite dental implant; Device: Osseotite dental implant

Study type: Interventional

Funder types: Industry

Identifiers

NCT00726063

2613

Details and patient eligibility

About

This study will evaluate the contributions of the Nanotite implant design when used by graduate students in their first year of placing implants.

Full description

This multicenter, prospective, randomized-controlled study will compare the performance of the Nanotite vs. the standard Ossotite implants when placed by graduate students with little or no prior experience. Enrolled patients will have the study site(s) randomized to either a Nanotite (test) or an Osseotite (control) implant. The manner of treatment observed at the participating center will be followed for this study.

Study Hypothesis: The performance of the Nanotite implant in this study will be no different than or superior to that of the Osseotite implant placed during the early period of graduate student training.

Enrollment: 241 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients of either sex and of any race, 18 years of age or older
• patients for whom a decision has already been made to use dental implants for treating edentulism in the mandible or maxilla

Exclusion criteria

• patients who are known to be pregnant

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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241 participants in 2 patient groups

Nanotite implant

Experimental group

Description:

Nanotite dental implant

Treatment:

Device: Nanotite dental implant

Osseotite implant

Active Comparator group

Description:

Osseotite dental implant

Treatment:

Device: Osseotite dental implant