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

Partial Edentulism Clinical Trial

— Polaris  

Official title:

A Prospective Randomized-Controlled Evaluation of an Implant System With a Novel Abutment Attachment Design for the Preservation of Crestal Bone

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01529879
• Other study ID #: 3014
• Status: Completed
• Phase: N/A
• Start date: August 2011
• Est. completion date: December 2016

Study information

• Verified date: March 2022
• Source: ZimVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Partial Edentulism
• Tooth Disease
• Tooth Diseases

Intervention

Device:
• New Abutment Connection implant
New abutment connection implant
• Nanotite Certain Tapered implant
Nanotite Certain Tapered (standard abutment connection) implant

Locations

Country	Name	City	State
Colombia	UNICOC	Bogota

Sponsors (1)

Lead Sponsor	Collaborator
ZimVie

Country where clinical trial is conducted

Colombia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cumulative success rate	Crestal bone regression (amount of bone loss measured) and equivalence in integration success (implant mobility)	2 years