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

Primary Purpose

Bone Loss, Alveolar

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Zimmer T3 Short Ex Hex With Discrete Crystalline Deposition
Zimmer T3 with DCD Ex Hex Parallel Walled implants
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Bone Loss, Alveolar

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • University of Michigan School of Dentistry

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Short Implant

Long Implant

Arm Description

17 patients will receive a 5 mm short implant.

17 patients will receive a sinus lift procedure, bone graft, and 10 mm implant.

Outcomes

Primary Outcome Measures

Change in mesial-distal (M-D) bone loss
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

Survival rate
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
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
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.

Full Information

First Posted
October 28, 2019
Last Updated
November 23, 2022
Sponsor
University of Michigan
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1. Study Identification

Unique Protocol Identification Number
NCT04144322
Brief Title
Short Dental Implants (5 mm) Versus Long Dental Implants (10 mm)
Official Title
Short Dental Implants (5 mm) Versus Long Dental Implants (10 mm) in Combination With Sinus Floor Elevation: A Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 14, 2019 (Actual)
Primary Completion Date
April 30, 2024 (Anticipated)
Study Completion Date
April 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bone Loss, Alveolar

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Short Implant
Arm Type
Other
Arm Description
17 patients will receive a 5 mm short implant.
Arm Title
Long Implant
Arm Type
Other
Arm Description
17 patients will receive a sinus lift procedure, bone graft, and 10 mm implant.
Intervention Type
Device
Intervention Name(s)
Zimmer T3 Short Ex Hex With Discrete Crystalline Deposition
Intervention Description
Placement of a short implant
Intervention Type
Device
Intervention Name(s)
Zimmer T3 with DCD Ex Hex Parallel Walled implants
Intervention Description
Placement of a long implant with sinus lift and bone graft
Primary Outcome Measure Information:
Title
Change in mesial-distal (M-D) bone loss
Description
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.
Time Frame
Baseline, surgical visit 1 day, 4 months, 5 months, 12 months, 24 months
Secondary Outcome Measure Information:
Title
Survival rate
Description
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.
Time Frame
5 month post-op, 12 month post-op, and 24 month post-op visits
Title
Number of sites with bleeding on probing
Description
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.
Time Frame
5 month post-op, 12 month post-op, and 24 month post-op visits
Title
Probing pocket depth
Description
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.
Time Frame
5 month post-op, 12 month post-op, and 24 month post-op visits

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tae-Ju Oh
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan School of Dentistry
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
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24818208
Citation
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Results Reference
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Citation
Anitua E, Pinas L, Orive G. Retrospective study of short and extra-short implants placed in posterior regions: influence of crown-to-implant ratio on marginal bone loss. Clin Implant Dent Relat Res. 2015 Feb;17(1):102-10. doi: 10.1111/cid.12073. Epub 2013 May 8.
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Citation
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Citation
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Citation
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Short Dental Implants (5 mm) Versus Long Dental Implants (10 mm)

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