Assessment of Integration Success of an Implant System With a Novel Abutment Attachment Design in Early Loaded Cases (Comet)

ZimVie

Status: Completed

Conditions: Tooth Disease; Partial Edentulism

Treatments: Device: Implant with new abutment connection; Device: Nanotite Certain Tapered implant

Study type: Interventional

Funder types: Industry

Identifiers

NCT01529814

3012

Details and patient eligibility

About

Integration success rates measured by resistance to countertorque testing will be higher for the experimental implant design 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 countertorque testing and cumulative success rate in cases that are loaded early

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: Implant with new abutment connection

Nanotite Certain Tapered implant

Active Comparator group

Description:

Nanotite Certain Tapered (standard abutment connection) implant

Treatment:

Device: Nanotite Certain Tapered implant