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Dental Implant Stability When Using the Densah Bur™ Bone Compaction Process to Prepare Dental Implant Sites

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ClinicalTrials.gov Identifier: NCT02502058
Recruitment Status : Withdrawn (Principal Investigator left her employment at the University.)
First Posted : July 17, 2015
Last Update Posted : June 20, 2017
Sponsor:
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute

Brief Summary:
The primary objective of this study is to determine if the use of a bone compaction process (osseodensification) (Densah™ bur: Versah Osseodensification Company™) to prepare dental implant sites, in human subjects, results in increased bone-ridge width, increased compact bone in the outer wall of the prepared sites, and dental implant stability.

Condition or disease Intervention/treatment
Missing Teeth Device: Densah Bur™ , osseodensification

Detailed Description:
The proposed project will be an observational, case-series study. The investigators anticipate enrolling 40 study subjects. Treatment Procedures: Following initial treatment planning discussions between the dentists and their patients regarding all of their dental treatment options, those patients who opt to have dental implants placed will be approached to discuss participation in the current study. Before entry into the study, the Investigator or an authorized member of the investigational staff will explain to potential subjects the aims, methods, reasonable anticipated benefits, and potential hazards of the study, and any discomfort it may entail. Subjects will be informed that their participation is voluntary and that they may withdraw consent to participate at any time. They will be informed that choosing not to participate will not affect the care the subject will receive for the treatment of their condition. Subjects will be told that alternative treatments are available and that if they decline to take part in the present study that such a refusal will not prejudice future treatment. Those patients who are willing to participate will be scheduled for their initial and follow-up dental implant visits at the School of Dentistry. At the baseline visit the study outcome data will be collected; including: 1) measuring the bone-ridge width, before and after implant site preparation (drilling); 2) intraoral photographs of the prepared opening; 3) dental implant torque readings will be obtained; and 4) ISQ as measure of both initial and the dynamic development of osseointegration (the formation of a direct interface between the dental implant and bone) over time. The ISQ measurements will be collected again at three and six-weeks post treatment.

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Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Observational, Case-Series Study Evaluation of Bone Width and Dental Implant Stability When Using the Densah Bur™ Bone Compaction Process to Prepare Dental Implant Sites
Study Start Date : July 2015
Actual Primary Completion Date : March 2017
Actual Study Completion Date : March 2017

Resource links provided by the National Library of Medicine



Intervention Details:
  • Device: Densah Bur™ , osseodensification
    Densah™ bur (Versah Osseodensification Company™) is used to prepare dental implant sites, in human subjects, by compacting (osseodensification ) bone vs. removing bone to create the opening in the jaw bone into which the dental implant is then placed. This osseodensification process results in increased bone-ridge width, increased compact bone in the outer wall of the prepared sites, and; it is believed, increases implant stability.
    Other Name: Versah Osseodensification Company™


Primary Outcome Measures :
  1. Bone-ridge width before and immediately after preparation of the implant site when using the Densah Bur. [ Time Frame: intraoperative ]
    The width of the bony ridge into which the dental implant will be placed will be measured immediately before drilling the opening with the Densah Bur and then again following completion of drilling but before the dental implant is placed into the prepared opening. These measurements will occur at the time of the implant surgery.


Secondary Outcome Measures :
  1. insertion torque value (ITV) [ Time Frame: intraoperative ]
    ITV is a measure of the rotational friction between the implant and the surrounding bone

  2. implant stability quotient (ISQ) [ Time Frame: intraoperative , at 3 weeks and 6 weeks post surgery ]
    ISQ uses resonance frequency analysis to determine if the newly prepared implant site is stable enough for immediate or early loading of the actual dental implant.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
The study subjects will include 40 healthy adult patients who seek dental implant placement to replace missing teeth in their mouths.
Criteria

Inclusion Criteria:

  1. Males and females
  2. Ages 18-80 years of age
  3. Missing at least one tooth.
  4. Capable of giving informed consent

Exclusion Criteria:

  1. Patient is a pregnant female
  2. Patient smoking more than 5 cigarettes per day
  3. Patient has a history of alcoholism or drug abuse during the last 5 years
  4. Patient with uncontrolled hypertension or diabetes
  5. Patient has a malignant tumor
  6. Patient is on daily dose of steroids
  7. Patient with history of chemotherapy or radiation for the last 12 months
  8. Patient who is immuno suppressed
  9. Patient with titanium allergy
  10. Subject should not be a homeless person

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): NCT02502058


Locations
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United States, Minnesota
Oral Health Research Clinic at the School of Dentistry at the University of Minnesota
Minneapolis, Minnesota, United States, 55455
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
Investigators
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Principal Investigator: Patricia A Lenton, MA University of Minnesota - Clinical and Translational Science Institute

Additional Information:
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Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT02502058     History of Changes
Other Study ID Numbers: University_of_Minnesota2
First Posted: July 17, 2015    Key Record Dates
Last Update Posted: June 20, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No plan to share study data.

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