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

NCT ID: NCT00723944

Last Updated: 2022-04-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 102 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-02-28
• Study Completion Date: 2011-05-31

Brief 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.

Detailed 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.

Conditions

Partial Edentulism; Tooth Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Osseotite Certain Prevail

Dental implant with lateralized design

Group Type: ACTIVE_COMPARATOR

Osseotite Certain Prevail

Intervention Type: DEVICE

Root form titanium dental implant

Osseotite Certain

Dental implant without the lateralized design

Group Type: PLACEBO_COMPARATOR

Osseotite Certain

Intervention Type: DEVICE

Dental implant without the lateralized design

Interventions

Osseotite Certain Prevail

Root form titanium dental implant

Intervention Type: DEVICE

Osseotite Certain

Dental implant without the lateralized design

Intervention Type: DEVICE

Other Intervention Names

Osseotite; Certain; Prevail; Osseotite; Certain

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ZimVie

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anton Friedmann, DMD

Role: PRINCIPAL_INVESTIGATOR

Charite- Zentrum fur Zahnmedizin

Locations

Charite- Universitatsmedizin Berlin

Berlin, , Germany

Countries

Germany

Other Identifiers

2302

Identifier Type: -

Identifier Source: org_study_id