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.

Study Overview

• Status: Completed
• Conditions: Tooth Loss

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:

• 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)

• Study Type: Observational
• Enrollment (Actual): 45

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • University of Minnesota Dental school clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
initial implant stability	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.	measued immediately after each dental implant is placed in patient's mouth.

Collaborators and Investigators

• Sponsor: University of Minnesota
• Collaborators: Dentsply Sirona Implants
• Investigators: Principal Investigator: Wook-Jin Seong, DDS, MS, PhD, University of Minnesota

Study record dates

Study Major Dates

• Study Start: September 1, 2010
• Primary Completion (Actual): October 1, 2018
• Study Completion (Actual): October 1, 2018

Study Registration Dates

• First Submitted: November 1, 2010
• First Submitted That Met QC Criteria: November 8, 2010
• First Posted (Estimate): November 9, 2010

Study Record Updates

• Last Update Posted (Actual): October 11, 2018
• Last Update Submitted That Met QC Criteria: October 9, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: initial dental implant stability; maxillary sinus proximity; bicortical fixation
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Tooth Diseases; Tooth Loss
• Other Study ID Numbers: 1003M78573; D-2010-021 (Other Identifier: Astra Tech)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No