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

Sponsor
ZimVie (Industry)
Overall Status
Completed
CT.gov ID
NCT01529866
Collaborator
(none)
60
Enrollment
1
Location
2
Arms
64
Duration (Months)
0.9
Patients Per Site Per Month

Study Details

Study Description

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
  • Device: New Abutment Connection implant
  • Device: Nanotite Certain Tapered implant
 N/A

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 Design

Study Type:
Interventional
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 :
Aug 1, 2011
Actual Primary Completion Date :
Dec 1, 2016
Actual Study Completion Date :
Dec 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: New abutment connection implant

Implant with new abutment connection

Device: New Abutment Connection implant
New abutment connection implant
Other Names:
  • 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 Names:
  • Nanotite Endosseous dental implant

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Cumulative success rate [2 years]

      crestal bone regression (amount of bone loss measured) and equivalence in integration success (implant mobility)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Universidad de Chile Santiago Chile

    Sponsors and Collaborators

    • ZimVie

    Investigators

    • Principal Investigator: Juan C Carvajal, DDS, University of Chile

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    ZimVie
    ClinicalTrials.gov Identifier:
    NCT01529866
    Other Study ID Numbers:
    • 3013
    First Posted:
    Feb 9, 2012
    Last Update Posted:
    Mar 28, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by ZimVie
    clinical study
    edentulism
    dental implants
    Nanotite Certain Tapered implant
    randomized
    crestal bone level
    immediate loading
    Additional relevant MeSH terms:
    Tooth Diseases

    Study Results

    No Results Posted as of Mar 28, 2022