Initial Stability of Posterior Maxillary Implants With Bicortical Fixation

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Dentsply Implants
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT01237184
First received: November 1, 2010
Last updated: December 16, 2013
Last verified: December 2013

November 1, 2010
December 16, 2013
September 2010
August 2014   (final data collection date for primary outcome measure)
initial implant stability [ Time Frame: measued immediately after each dental implant is placed in patient's mouth. ] [ Designated as safety issue: No ]
The investigators expect the recruitments and implant placement surgeries for 45 implants will take a year so initial implant stability of each one of 45 implants will be measured over the 1 year period.
initial implant stability [ Time Frame: immediately after each dental implant is placed in patient. ] [ Designated as safety issue: No ]
The investigators expect the recruitments and implant placement surgeries for 45 implants will take a year so initial implant stability of each one of 45 implants will be measured over the 1 year period.
Complete list of historical versions of study NCT01237184 on ClinicalTrials.gov Archive Site
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Initial Stability of Posterior Maxillary Implants With Bicortical Fixation
Comparison of Initial Implant Stability of Posterior Maxillary Implants With Bicortical Fixation to Implants Engaging Only the Alveolar Crest

The primary purpose of this study is to

  1. determine whether dental implant engaging both the alveolar crest cortical bone and sinus floor using vertical stopper drill and self-threading concept (bi-cortical fixation) increases initial implant stability compared to the short implants engaging only alveolar crest cortical bone (uni-cortical fixation) and/or ones engaging both crest and sinus floor but with green stick fracture (indirect sinus lift technique),
  2. study whether different surgical techniques, residual bone height, bone density, and length and width of the implants used affect initial implant stability in posterior maxilla. In addition, this study will continue to
  3. compare secondary implant stability of implants fixed bi-cortically, uni-cortically and with indirect sinus lift technique at 2nd stage surgery/6 month healing and 1 year follow-up from the restoration and
  4. measure amount of endo-sinus bone formation from the 1- year follow up CT (computer tomogram) scan and evaluate safety and potential post-operative complications of bi-cortical fixation and indirect sinus lift technique reported throughout the follow up periods.

The clinical trial will evaluate initial implant stability as a primary outcome measured by resonance frequency analysis (RFA) employing dental implants surgically placed in posterior maxillary bone by engaging alveolar crest and the sinus floor using vertical stopper drill and self-threading concept (bi-cortical fixation), engaging only the alveolar crest (uni-cortical fixation), and engaging alveolar crest and the sinus floor using indirect sinus lift technique (indirect sinus lift technique). The surgical procedures compared in this experiment include 3 groups:

  • Group 1 (15 implants) Short implants placed in proximity of the sinus without sinus floor involvement (unicortical fixation)
  • Group 2 (15 implants) Implants placed using indirect sinus lift technique (indirect sinus lift technique)
  • Group 3 (15 implants) Bi-cortically fixed implants intentionally engaging sinus floor beyond up to 1-2mm without graft but using stopper drill and self-threading concept (bi-cortical fixation)
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

Eligible volunteers must be at least 18 years old, partially edentulous in maxillary posterior region with 7-11 mm residual bone height under the sinus floor and be indicated for CBCT scan for diagnosis and treatment planning, and of a medical risk of ASA I or II classification to participate. Patients with bone pathology, sinus infection, and who are pregnant will be excluded.

Implants requiring tapping, site of an implant replacement, and implant with dehiscence and/or fenestration will be excluded.

Tooth Loss
Not Provided
  • biocortical fixation
    Bi-cortically fixed implants intentionally engaging sinus floor beyond up to 1-2mm without graft but using stopper drill and self-threading concept
  • unicortical fixation
    Short implants placed in proximity of the sinus without sinus floor involvement
  • indirect sinus lift
    implants engaging both crest and sinus floor but with green stick fracture
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
45
August 2014
August 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Eligible volunteers must be at least 18 years old, partially edentulous in maxillary posterior region with 7-11 mm residual bone height under the sinus floor and be indicated for CBCT scan for diagnosis and treatment planning, and of a medical risk of ASA I or II classification to participate.

Exclusion Criteria:

  • Patients with bone pathology, sinus infection, and who are pregnant will be excluded. Implants requiring tapping, site of an implant replacement, and implant with dehiscence and/or fenestration will be excluded.
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01237184
1003M78573, D-2010-021
No
University of Minnesota - Clinical and Translational Science Institute
University of Minnesota - Clinical and Translational Science Institute
Dentsply Implants
Principal Investigator: Wook-Jin Seong, DDS, MS, PhD University of Minnesota - Clinical and Translational Science Institute
University of Minnesota - Clinical and Translational Science Institute
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP