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Short Dental Implants (5 mm) Versus Long Dental Implants (10 mm)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04144322
Recruitment Status : Enrolling by invitation
First Posted : October 30, 2019
Last Update Posted : November 5, 2020
Sponsor:
Information provided by (Responsible Party):
Tae-Ju Oh, University of Michigan

Tracking Information
First Submitted Date  ICMJE October 28, 2019
First Posted Date  ICMJE October 30, 2019
Last Update Posted Date November 5, 2020
Actual Study Start Date  ICMJE October 14, 2019
Estimated Primary Completion Date April 30, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 29, 2019)
Change in mesial-distal (M-D) bone loss [ Time Frame: Baseline, surgical visit 1 day, 4 months, 5 months, 12 months, 24 months ]
Comparing mesial-distal (M-D) bone loss between the two groups. This will be measured in millimeters using standardized radiographs of the implant site at the screening visit, surgical visit, 4 months post-op, 5 months post-op, 12 months post-op, and 24 months post-op visits.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 29, 2019)
  • Survival rate [ Time Frame: 5 month post-op, 12 month post-op, and 24 month post-op visits ]
    The survival rate of the two groups will be recorded as a percentage at the 5 month post-op, 12 month post-op, and 24 month post-op visits based on clinician assessment.
  • Number of sites with bleeding on probing [ Time Frame: 5 month post-op, 12 month post-op, and 24 month post-op visits ]
    The number of sites with bleeding on probing will be compared between the two groups. Bleeding on probing of the implant site will be measured with a periodontal probe at the 5 month post-op, 12 month post-op, and 24 month post-op visits.
  • Probing pocket depth [ Time Frame: 5 month post-op, 12 month post-op, and 24 month post-op visits ]
    The probing pocket depths will be compared between the two groups. Probing depths of the implant site will be measured with a periodontal probe at the 5 month post-op, 12 month post-op, and 24 month post-op visits.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Short Dental Implants (5 mm) Versus Long Dental Implants (10 mm)
Official Title  ICMJE Short Dental Implants (5 mm) Versus Long Dental Implants (10 mm) in Combination With Sinus Floor Elevation: A Randomized Clinical Trial
Brief Summary

The purpose of this study is to evaluate the survival rate of 5 mm short implants compared to longer implants (10 mm) placed in sinus-grafted sites.

Primary aim: Compare bone loss between the two groups Secondary aim: Compare surgical time and patient-reported outcomes (satisfaction and post-operative pain)

Detailed Description 34 patients requiring an implant to replace an upper missing tooth in the premolar or 1st molar area with a bone crest height from 5 to 8 mm will be recruited for this trial. Patients will be randomized to either the test (5-mm implant) or control group (10-mm implant) using a computer-generated randomization list . 17 patients will receive a sinus lift procedure, bone graft, and 10 mm implant while the other 17 patients will receive a 5 mm short implant.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Bone Loss, Alveolar
Intervention  ICMJE
  • Device: Zimmer T3 Short Ex Hex With Discrete Crystalline Deposition
    Placement of a short implant
  • Device: Zimmer T3 with DCD Ex Hex Parallel Walled implants
    Placement of a long implant with sinus lift and bone graft
Study Arms  ICMJE
  • Short Implant
    17 patients will receive a 5 mm short implant.
    Intervention: Device: Zimmer T3 Short Ex Hex With Discrete Crystalline Deposition
  • Long Implant
    17 patients will receive a sinus lift procedure, bone graft, and 10 mm implant.
    Intervention: Device: Zimmer T3 with DCD Ex Hex Parallel Walled implants
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Enrolling by invitation
Estimated Enrollment  ICMJE
 (submitted: October 29, 2019)
34
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 30, 2023
Estimated Primary Completion Date April 30, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age 20-70 years at enrollment
  • Systemically healthy patients
  • Full-mouth plaque score and full-mouth bleeding score ≤ 30% (measured at four sites per tooth)
  • In need of one premolar or 1st molar dental implant in the maxillary area
  • Neighboring teeth to the planned implant must have natural root(s) or implant supported restoration.
  • Presence of natural tooth/teeth, partial prosthesis and/or implants in the opposite jaw in contact with the planned crown/s deemed by the investigator as likely to present an initially stable implant situation
  • Residual bone height under the maxillary sinus between 5 to 7 mm and a width of at least 7 mm, as measured on cone beam computer tomography (CBCT) scans.

Exclusion Criteria:

  • Unlikely to be able to comply with study procedures
  • Uncontrolled pathologic processes in the oral cavity
  • History of head and neck chemotherapy within 5 years prior to surgery
  • Systemic or local disease or condition that could compromise post-operative healing and/or osseointegration
  • Uncontrolled diabetes mellitus HbA1c >8
  • Taking corticosteroids, IV bisphosphonates, or any other medication that could influence post-operative healing and/or osseointegration
  • Smokes more than 10 cigarettes/day
  • Bruxer
  • Present alcohol and/or drug abuser
  • Pregnant, unsure pregnancy status, or lactating females (self-reported)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04144322
Other Study ID Numbers  ICMJE HUM00151047
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Tae-Ju Oh, University of Michigan
Study Sponsor  ICMJE University of Michigan
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Tae-Ju Oh University of Michigan
PRS Account University of Michigan
Verification Date November 2020

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