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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

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)


Condition or disease Intervention/treatment Phase
Bone Loss, Alveolar Device: Zimmer T3 Short Ex Hex With Discrete Crystalline Deposition Device: Zimmer T3 with DCD Ex Hex Parallel Walled implants Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Short Dental Implants (5 mm) Versus Long Dental Implants (10 mm) in Combination With Sinus Floor Elevation: A Randomized Clinical Trial
Actual Study Start Date : October 14, 2019
Estimated Primary Completion Date : April 30, 2023
Estimated Study Completion Date : April 30, 2023

Arm Intervention/treatment
Short Implant
17 patients will receive a 5 mm short implant.
Device: Zimmer T3 Short Ex Hex With Discrete Crystalline Deposition
Placement of a short implant

Long Implant
17 patients will receive a sinus lift procedure, bone graft, and 10 mm implant.
Device: Zimmer T3 with DCD Ex Hex Parallel Walled implants
Placement of a long implant with sinus lift and bone graft




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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)

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): NCT04144322


Locations
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United States, Michigan
University of Michigan School of Dentistry
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
Investigators
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Principal Investigator: Tae-Ju Oh University of Michigan
Publications:

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Responsible Party: Tae-Ju Oh, Clinical Professor of Dentistry, University of Michigan
ClinicalTrials.gov Identifier: NCT04144322    
Other Study ID Numbers: HUM00151047
First Posted: October 30, 2019    Key Record Dates
Last Update Posted: November 5, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
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Alveolar Bone Loss
Bone Resorption
Bone Diseases
Musculoskeletal Diseases
Periodontal Atrophy
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases