Bone Loss, Alveolar
Conditions
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.
Interventions
DEVICEZimmer T3 Short Ex Hex With Discrete Crystalline Deposition
Placement of a short implant
DEVICEZimmer T3 with Discrete Crystalline Deposition Ex Hex Parallel Walled implants
Placement of a long implant with sinus lift and bone graft
Sponsors
University of Michigan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Mesial-distal (M-D) Bone Loss | 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
| Measure | Time frame | Description |
|---|---|---|
| Survival Rate | 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 | 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 | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Short Implant 17 patients will receive a 5 mm short implant.
Zimmer T3 Short Ex Hex With Discrete Crystalline Deposition: Placement of a short implant | 15 |
| Long Implant 17 patients will receive a sinus lift procedure, bone graft, and 10 mm implant.
Zimmer T3 with Discrete Crystalline Deposition Ex Hex Parallel Walled implants: Placement of a long implant with sinus lift and bone graft | 15 |
| Total | 30 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lack of Efficacy | 2 | 2 |
Baseline characteristics
| Characteristic | Short Implant | Long Implant | Total |
|---|---|---|---|
| Age, Continuous | 58.67 years STANDARD_DEVIATION 14.57 | 56.87 years STANDARD_DEVIATION 13.31 | 57.76 years STANDARD_DEVIATION 13.99 |
| Bone density D1 | 0 Participants | 0 Participants | 0 Participants |
| Bone density D2 | 0 Participants | 2 Participants | 2 Participants |
| Bone density D3 | 15 Participants | 13 Participants | 28 Participants |
| Bone density D4 | 0 Participants | 0 Participants | 0 Participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Residual ridge height | 5.74 millimeters STANDARD_DEVIATION 0.84 | 6.39 millimeters STANDARD_DEVIATION 1.53 | 6.07 millimeters STANDARD_DEVIATION 1.26 |
| Sex: Female, Male Female | 10 Participants | 6 Participants | 16 Participants |
| Sex: Female, Male Male | 5 Participants | 9 Participants | 14 Participants |
| Soft tissue phenotype Medium | 5 Participants | 7 Participants | 12 Participants |
| Soft tissue phenotype Thick | 3 Participants | 2 Participants | 5 Participants |
| Soft tissue phenotype Thin | 1 Participants | 3 Participants | 4 Participants |
| Soft tissue phenotype Very Thick | 6 Participants | 3 Participants | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 17 | 0 / 17 |
| other Total, other adverse events | 0 / 17 | 0 / 17 |
| serious Total, serious adverse events | 2 / 17 | 3 / 17 |
Outcome results
Primary
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.
Time frame: Baseline, surgical visit 1 day, 4 months, 5 months, 12 months, 24 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Short Implant | Change in Mesial-distal (M-D) Bone Loss | 4 months (second stage) | -0.41 millimeters | Standard Deviation 0.76 |
| Short Implant | Change in Mesial-distal (M-D) Bone Loss | 12 months | -0.74 millimeters | Standard Deviation 0.79 |
| Short Implant | Change in Mesial-distal (M-D) Bone Loss | 5 months (loading) | -0.55 millimeters | Standard Deviation 0.83 |
| Short Implant | Change in Mesial-distal (M-D) Bone Loss | 24 months | -0.84 millimeters | Standard Deviation 0.62 |
| Short Implant | Change in Mesial-distal (M-D) Bone Loss | Surgery visit | 0.63 millimeters | Standard Deviation 0.38 |
| Long Implant | Change in Mesial-distal (M-D) Bone Loss | 24 months | -059 millimeters | Standard Deviation 0.65 |
| Long Implant | Change in Mesial-distal (M-D) Bone Loss | Surgery visit | 0.61 millimeters | Standard Deviation 0.57 |
| Long Implant | Change in Mesial-distal (M-D) Bone Loss | 4 months (second stage) | -0.40 millimeters | Standard Deviation 1.04 |
| Long Implant | Change in Mesial-distal (M-D) Bone Loss | 5 months (loading) | -0.64 millimeters | Standard Deviation 0.75 |
| Long Implant | Change in Mesial-distal (M-D) Bone Loss | 12 months | -0.40 millimeters | Standard Deviation 0.57 |
Secondary
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.
Time frame: 5 month post-op, 12 month post-op, and 24 month post-op visits
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Short Implant | Number of Sites With Bleeding on Probing | 5 months (loading) | .03 implant sites | Standard Deviation 0.02 |
| Short Implant | Number of Sites With Bleeding on Probing | 12 months | .14 implant sites | Standard Deviation 0.05 |
| Short Implant | Number of Sites With Bleeding on Probing | 24 months | .35 implant sites | Standard Deviation 0.07 |
| Long Implant | Number of Sites With Bleeding on Probing | 5 months (loading) | .08 implant sites | Standard Deviation 0.05 |
| Long Implant | Number of Sites With Bleeding on Probing | 12 months | .39 implant sites | Standard Deviation 0.09 |
| Long Implant | Number of Sites With Bleeding on Probing | 24 months | .32 implant sites | Standard Deviation 0.08 |
Secondary
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.
Time frame: 5 month post-op, 12 month post-op, and 24 month post-op visits
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Short Implant | Probing Pocket Depth | 5 months (loading) | 2.84 millimeters | Standard Deviation 0.15 |
| Short Implant | Probing Pocket Depth | 12 months | 3.32 millimeters | Standard Deviation 0.14 |
| Short Implant | Probing Pocket Depth | 24 months | 3.79 millimeters | Standard Deviation 0.16 |
| Long Implant | Probing Pocket Depth | 5 months (loading) | 2.94 millimeters | Standard Deviation 0.15 |
| Long Implant | Probing Pocket Depth | 12 months | 3.27 millimeters | Standard Deviation 0.15 |
| Long Implant | Probing Pocket Depth | 24 months | 3.72 millimeters | Standard Deviation 0.16 |
Secondary
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.
Time frame: 5 month post-op, 12 month post-op, and 24 month post-op visits
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Short Implant | Survival Rate | 5 months (loading) | 17 Participants |
| Short Implant | Survival Rate | 12 months | 17 Participants |
| Short Implant | Survival Rate | 24 months | 15 Participants |
| Long Implant | Survival Rate | 5 months (loading) | 15 Participants |
| Long Implant | Survival Rate | 12 months | 15 Participants |
| Long Implant | Survival Rate | 24 months | 15 Participants |