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Study of the Integration Success of an Implant System With a Novel Abutment Attachment Design in Immediate Loading Cases (Bridge)

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ClinicalTrials.gov Identifier: NCT01529866
Recruitment Status : Completed
First Posted : February 9, 2012
Last Update Posted : March 31, 2017
Sponsor:
Information provided by (Responsible Party):
Zimmer Biomet

Brief Summary:
Integration success rates measured by lack of implant mobility and crestal bone regression measurement will be higher for the experimental implant design than for the control implants.

Condition or disease Intervention/treatment Phase
Partial Edentulism Tooth Disease Device: New Abutment Connection implant Device: Nanotite Certain Tapered implant Not Applicable

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 cumulative success rate in cases that are loaded immediately

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: A Prospective Randomized-controlled Study of the Integration Success Rate of an Implant System With a Novel Abutment Attachment in Cases Loaded Immediately
Study Start Date : August 2011
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

Arm Intervention/treatment
Experimental: New abutment connection implant
Implant with new abutment connection
Device: New Abutment Connection implant
New abutment connection implant
Other Name: Osseotite Endosseous dental implant
Active Comparator: Nanotite Certain Tapered implant
Nanotite Certain Tapered (standard abutment connection) implant
Device: Nanotite Certain Tapered implant
Nanotite certain tapered (standard abutment connection) implant
Other Name: Nanotite Endosseous dental implant



Primary Outcome Measures :
  1. Cumulative success rate [ Time Frame: 2 years ]
    crestal bone regression (amount of bone loss measured) and equivalence in integration success (implant mobility)



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01529866


Locations
Chile
Universidad de Chile
Santiago, Chile
Sponsors and Collaborators
Zimmer Biomet
Investigators
Principal Investigator: Juan C Carvajal, DDS University of Chile

Responsible Party: Zimmer Biomet
ClinicalTrials.gov Identifier: NCT01529866     History of Changes
Other Study ID Numbers: 3013
First Posted: February 9, 2012    Key Record Dates
Last Update Posted: March 31, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Zimmer Biomet:
clinical study
edentulism
dental implants
Nanotite Certain Tapered implant
randomized
crestal bone level
immediate loading

Additional relevant MeSH terms:
Tooth Diseases
Stomatognathic Diseases