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

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ClinicalTrials.gov Identifier: NCT02397044
Recruitment Status : Unknown
Verified March 2015 by David E. Simmons D.D.S., Louisiana State University Health Sciences Center in New Orleans.
Recruitment status was:  Active, not recruiting
First Posted : March 24, 2015
Last Update Posted : March 24, 2015
Sponsor:
Collaborator:
Zimmer Dental
Information provided by (Responsible Party):
David E. Simmons D.D.S., Louisiana State University Health Sciences Center in New Orleans

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.

Condition or disease Intervention/treatment
Missing Tooth Procedure: Implant surgery

Detailed Description:
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).

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Study Type : Observational
Actual Enrollment : 48 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Immediate and Early Loading of Hydrothermally Treated, Hydroxyapatite-Coated Dental Implants:a Controlled Randomized Prospective Clinical Study
Study Start Date : December 2010
Actual Primary Completion Date : December 2012
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Implant loading Immediate
Dental implant surgery with immediate loading
Procedure: Implant surgery
Compare surgical protocols

Implant Loading Early
Dental implant surgery with delayed loading
Procedure: Implant surgery
Compare surgical protocols




Primary Outcome Measures :
  1. Primary Endpoint Measurement: Implant survival [ Time Frame: 6 months ]
    The primary endpoint for this protocol is implant survival.

  2. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Healthy volunteers over the age of 18 needing a tooth replacement.
Criteria

Inclusion Criteria:

  1. May be either male or female
  2. Must be at least 18 years of age
  3. Must be of sufficiently good health to undergo routine dental treatment. including the surgical procedures associated with placement of dental implants.
  4. Must be partially edentulous requiring single dental implants in their maxilla or mandible
  5. Must have sufficient amount of native bone or healed bone grafted sites (by socket grafting, maxillary sinus augmentation and ridge augmentation).
  6. Must not have any active infection
  7. Must have adequate bone height for at least a 10mm long dental implant
  8. Must be physically, emotionally and financially able to undergo the surgical procedure planned
  9. Must be adequately compliant

Exclusion Criteria:

  1. Have any requirements for antibiotic premedication for infective endocarditis, artificial joints or any other condition
  2. Have uncontrolled hypertension
  3. Have uncontrolled diabetes
  4. Are serological HIV positive
  5. Have a history of significant heart, stomach, liver, kidney, blood, immune system or other organ impairment or systemic disease that would prevent their undergoing the proposed treatment
  6. Smoke cigarettes or use other tobacco products
  7. Have taken any investigational drugs anytime in the previous month
  8. Have dental conditions likely to require treatment, necessitating exit from the study such as deep cavities, abscesses, or moderate-severe gum disease
  9. Have had radiation therapy to the head and neck
  10. Are unwilling or unable to sign the informed consent
  11. Don't demonstrate willingness to return for a required number of visits
  12. Need an immediate dental implant placement following tooth extraction


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): NCT02397044


Sponsors and Collaborators
Louisiana State University Health Sciences Center in New Orleans
Zimmer Dental
Investigators
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Principal Investigator: David E Simmons, D.D.S. LSU Helath Sciences Center

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Responsible Party: David E. Simmons D.D.S., Assistant Professor Department of Periodontics, Louisiana State University Health Sciences Center in New Orleans
ClinicalTrials.gov Identifier: NCT02397044     History of Changes
Other Study ID Numbers: IRB 7438
First Posted: March 24, 2015    Key Record Dates
Last Update Posted: March 24, 2015
Last Verified: March 2015

Keywords provided by David E. Simmons D.D.S., Louisiana State University Health Sciences Center in New Orleans:
Implants, stability, loading

Additional relevant MeSH terms:
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Tooth Loss
Anodontia
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Tooth Diseases
Tooth Abnormalities
Stomatognathic System Abnormalities
Congenital Abnormalities