Assessment of the Effect of an Implant System With a Novel Abutment Attachment Design on Crestal Bone Preservation (Polaris)

ZimVie

Status: Completed

Conditions: Tooth Disease; Partial Edentulism

Treatments: Device: New Abutment Connection implant; Device: Nanotite Certain Tapered implant

Study type: Interventional

Funder types: Industry

Identifiers

NCT01529879

3014

Details and patient eligibility

About

Integration success rates and the preservation of crestal bone will be higher for the experimental device than for the control implants.

Full description

In this study patients are randomized to receive either the experimental implant system or the control Nanotite Certain Tapered (standard abutment connection) and assessed for integration success measured by lack of implant mobility and lack of bone loss obtained at various study time points

Enrollment: 49 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients of either sex and older than 18 years of age
• patients needing at least one dental implant to treat partial edentulism
• patients physically able to tolerate surgical and restorative dental procedures
• patients agreeing to all protocol visits

Exclusion criteria

• patients with infection or severe inflammation at the intended treatment sites
• patients smoking greater than 10 cigarettes per day
• patients with uncontrolled diabetes mellitus
• patients with uncontrolled metabolic diseases
• patients who received radiation treatment to the head in the past 12 months
• patients needing bone grafting at the intended treatment sites
• patients known to be pregnant at screening visit
• patients with para-functional habits like bruxing and clenching

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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49 participants in 2 patient groups

New abutment connection implant

Experimental group

Description:

Implant with new abutment connection

Treatment:

Device: New Abutment Connection implant

Nanotite Certain Tapered implant

Active Comparator group

Description:

Nanotite Certain Tapered (standard abutment connection) implant

Treatment:

Device: Nanotite Certain Tapered implant