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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Bone Loss, Alveolar

Intervention / Treatment
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* Device: Zimmer T3 Short Ex Hex With Discrete Crystalline Deposition
* Device: Zimmer T3 with DCD Ex Hex Parallel Walled implants


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Short Implant<br>17 patients will receive a 5 mm short implant. | Device: Zimmer T3 Short Ex Hex With Discrete Crystalline Deposition<br>* Placement of a short implant<br>|
| Other: Long Implant<br>17 patients will receive a sinus lift procedure, bone graft, and 10 mm implant. | Device: Zimmer T3 with DCD Ex Hex Parallel Walled implants<br>* Placement of a long implant with sinus lift and bone graft<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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