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

May 2, 2025 updated by: Tae-Ju Oh, University of Michigan

Short Dental Implants (5 mm) Versus Long Dental Implants (10 mm) in Combination With Sinus Floor Elevation: A Randomized Clinical Trial

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)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

34

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan School of Dentistry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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
Other: Long Implant
17 patients will receive a sinus lift procedure, bone graft, and 10 mm implant.
Device: Zimmer T3 with Discrete Crystalline Deposition Ex Hex Parallel Walled implants
Placement of a long implant with sinus lift and bone graft

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, surgical visit 1 day, 4 months, 5 months, 12 months, 24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
5 month post-op, 12 month post-op, and 24 month post-op visits
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.
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.
5 month post-op, 12 month post-op, and 24 month post-op visits

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Michigan

Investigators

  • Principal Investigator: Tae-Ju Oh, University of Michigan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 14, 2019

Primary Completion (Actual)

April 22, 2024

Study Completion (Actual)

April 22, 2024

Study Registration Dates

First Submitted

October 28, 2019

First Submitted That Met QC Criteria

October 29, 2019

First Posted (Actual)

October 30, 2019

Study Record Updates

Last Update Posted (Actual)

May 6, 2025

Last Update Submitted That Met QC Criteria

May 2, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HUM00151047

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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