Clinical Trial: "Prospective Evaluation of Immediate & Early Loading of Zimmer Hydroxyapatite Coated Dental Implants"

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Observational

Official Title: Immediate and Early Loading of Hydrothermally Treated, Hydroxyapatite-Coated Dental Implants:a Controlled Randomized Prospective Clinical Study

Brief Summary: The purpose of this study is to compare the success rates of two surgical protocols. One protocol will have the implants placed at the time of tooth extraction and placed into function. The other protocol will have the implants placed into healed extraction sites and placed into function.

Detailed Summary: Forty-eight patients (22 men, 26 women) were enrolled in the study and received 48 implants. The population was divided into 2 groups: Group A implants (n=23) were loaded immediately on the day of surgery and Group B implants (n=19) were loaded 3 weeks after surgery. Cone Beam Computed Tomography (CBCT) scans were taken preoperatively to aid in treatment planning. Bone density was evaluated on CBCT scans in Hounsfield units (HU) and by tactile feedback during surgery. Insertion torque was recorded at time of implant placement. Resonance frequency analysis, performed on the day of surgery, at the time of loading, and at 6, 12 and 24 months, was used to record implant stability according to the unit's Implant Stability Quotient (Osstell ISQ). Standardized radiographs were taken at time of implant placement and at 6, 12 and 24 months to measure crestal bone stability. Bone level changes were measured by software (Image J, available online at: http://rsbweb.nih.gov/ij/download.html; last accessed 28 August 2014).
Sponsor: Louisiana State University Health Sciences Center in New Orleans

Current Primary Outcome:

  • Primary Endpoint Measurement: Implant survival [ Time Frame: 6 months ]
    The primary endpoint for this protocol is implant survival.
  • Secondary Endpoint Measurements: Crestal Bone Loss, ISQ [ Time Frame: 1 year ]

    Implant survival

    • Crestal Bone Loss will be determined radiographically and will be defined as having occurred when greater than 1.5 mm of bone loss is evident. This endpoint will be summarized for the subgroups of the study population which are formed by stratifying on implant diameter, implant length, implant location and patient age. Rates of crestal bone loss will be computed at one year.
    • ISQ will be measured at the time of implant placement, at 5 months and at one year post implant placement. Insertion torque will be measured at time of placement only.


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Louisiana State University Health Sciences Center in New Orleans

Dates:
Date Received: March 18, 2015
Date Started: December 2010
Date Completion: December 2017
Last Updated: March 23, 2015
Last Verified: March 2015