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NCT01529814 Clinical Trial

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

Partial Edentulism Clinical Trial

— Comet  

Official title:
A Prospective Randomized-controlled Study of the Integration Success Rate of an Implant System With a Novel Abutment Attachment in Cases Loaded Early

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01529814
Other study ID # 3012
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 2011
Est. completion date December 2016

Study information
Verified date March 2022
Source ZimVie
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Implant with new abutment connection
New abutment connection implant system
• Nanotite Certain Tapered implant
Nanotite Certain Tapered (standard abutment connection) implant

Locations
Country Name City State
Chile Universidad Mayor Santiago

Sponsors (1)
Lead Sponsor Collaborator
ZimVie

Country where clinical trial is conducted

Chile, 

Outcome
Type Measure Description Time frame Safety issue
Primary Primary stability countertorque measures Resistance to countertorque measures showing primary stability success of implants 2 months
Secondary Cumulative success rate Crestal bone regression (amount of bone loss measured) and equivalence in integration success (implant mobility) 2 years
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