Initial Stability of Posterior Maxillary Implants With Bicortical Fixation
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| First Received Date ICMJE | November 1, 2010 | ||||||||
| Last Updated Date | March 4, 2013 | ||||||||
| Start Date ICMJE | September 2010 | ||||||||
| Estimated Primary Completion Date | August 2013 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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. |
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| Original Primary Outcome Measures ICMJE |
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. |
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| Change History | Complete list of historical versions of study NCT01237184 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Initial Stability of Posterior Maxillary Implants With Bicortical Fixation | ||||||||
| Official Title ICMJE | Comparison of Initial Implant Stability of Posterior Maxillary Implants With Bicortical Fixation to Implants Engaging Only the Alveolar Crest | ||||||||
| Brief Summary | The primary purpose of this study is to
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| Detailed Description | 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:
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| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Not Provided | ||||||||
| Sampling Method | Probability Sample | ||||||||
| Study Population | 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. |
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| Condition ICMJE | Tooth Loss | ||||||||
| Intervention ICMJE | Not Provided | ||||||||
| Study Group/Cohort (s) |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 45 | ||||||||
| Estimated Completion Date | September 2013 | ||||||||
| Estimated Primary Completion Date | August 2013 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01237184 | ||||||||
| Other Study ID Numbers ICMJE | 1003M78573, D-2010-021 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | University of Minnesota - Clinical and Translational Science Institute | ||||||||
| Study Sponsor ICMJE | University of Minnesota - Clinical and Translational Science Institute | ||||||||
| Collaborators ICMJE | Dentsply Implants | ||||||||
| Investigators ICMJE |
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| Information Provided By | University of Minnesota - Clinical and Translational Science Institute | ||||||||
| Verification Date | March 2013 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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