- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02397044
"Prospective Evaluation of Immediate & Early Loading of Zimmer Hydroxyapatite Coated Dental Implants"
March 23, 2015 updated by: David E. Simmons D.D.S., Louisiana State University Health Sciences Center in New Orleans
Immediate and Early Loading of Hydrothermally Treated, Hydroxyapatite-Coated Dental Implants:a Controlled Randomized Prospective Clinical Study
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.
Study Overview
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).
Study Type
Observational
Enrollment (Actual)
48
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Healthy volunteers over the age of 18 needing a tooth replacement.
Description
Inclusion Criteria:
- May be either male or female
- Must be at least 18 years of age
- Must be of sufficiently good health to undergo routine dental treatment. including the surgical procedures associated with placement of dental implants.
- Must be partially edentulous requiring single dental implants in their maxilla or mandible
- Must have sufficient amount of native bone or healed bone grafted sites (by socket grafting, maxillary sinus augmentation and ridge augmentation).
- Must not have any active infection
- Must have adequate bone height for at least a 10mm long dental implant
- Must be physically, emotionally and financially able to undergo the surgical procedure planned
Must be adequately compliant
-
Exclusion Criteria:
- Have any requirements for antibiotic premedication for infective endocarditis, artificial joints or any other condition
- Have uncontrolled hypertension
- Have uncontrolled diabetes
- Are serological HIV positive
- 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
- Smoke cigarettes or use other tobacco products
- Have taken any investigational drugs anytime in the previous month
- Have dental conditions likely to require treatment, necessitating exit from the study such as deep cavities, abscesses, or moderate-severe gum disease
- Have had radiation therapy to the head and neck
- Are unwilling or unable to sign the informed consent
- Don't demonstrate willingness to return for a required number of visits
Need an immediate dental implant placement following tooth extraction
-
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Implant loading Immediate
Dental implant surgery with immediate loading
|
Compare surgical protocols
|
Implant Loading Early
Dental implant surgery with delayed loading
|
Compare surgical protocols
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Primary Endpoint Measurement: Implant survival
Time Frame: 6 months
|
The primary endpoint for this protocol is implant survival.
|
6 months
|
Secondary Endpoint Measurements: Crestal Bone Loss, ISQ
Time Frame: 1 year
|
Implant survival
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: David E Simmons, D.D.S., LSU Helath Sciences Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2010
Primary Completion (Actual)
December 1, 2012
Study Completion (Anticipated)
December 1, 2017
Study Registration Dates
First Submitted
March 18, 2015
First Submitted That Met QC Criteria
March 23, 2015
First Posted (Estimate)
March 24, 2015
Study Record Updates
Last Update Posted (Estimate)
March 24, 2015
Last Update Submitted That Met QC Criteria
March 23, 2015
Last Verified
March 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB 7438
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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