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

Not Applicable

Completed

• Conditions: Partial Edentulism; Tooth Disease
• Interventions: Device: Nanotite Certain Tapered implant; Device: New Abutment Connection implant

• Registration Number: NCT01529879
• Lead Sponsor: ZimVie

Brief Summary

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

Detailed 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

Study Timeline

• Study Start: 2011-08
• Study First Submitted: 2012-02-07
• Study First Submitted QC: 2012-02-08
• Study First Posted: 2012-02-09
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-24
• Last Update Posted: 2022-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 49

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nanotite Certain Tapered implant	Nanotite Certain Tapered implant	Nanotite Certain Tapered (standard abutment connection) implant
New abutment connection implant	New Abutment Connection implant	Implant with new abutment connection

Primary Outcome Measures

Name	Time	Method
Cumulative success rate	2 years	Crestal bone regression (amount of bone loss measured) and equivalence in integration success (implant mobility)

Trial Locations

Locations (1)

UNICOC; 🇨🇴 Bogota, Colombia