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The evaluation of the bone, using several techniques and on several aspects will be the purpose to study the possible impact of the kidney transplant (and, extensively, the pre-transplant dialysis, the organ replacement and the immunosuppressive therapy) could have on the bone metabolism and on the density of the bone where the implants are placed. The assessment on the bone density only in a retrospectively selected population that underwent the same surgical procedure will help the comparison of the data to get a satisfactory conclusion. The evaluation of other clinical and instrumental parameters in the test group makes the kidney-transplant patients bone quality clear, and will consequently demonstrate if implants are a feasible therapy for these patients.
The primary purpose of this study is the evaluation of the effects of the kidney transplant on the periimplant bone density by the comparison with the density of healthy patients. The secondary purpose is obtaining clinical, histological and radiographic data to evaluate the effect of systemic conditions and its rebound on the insertion of fixtures.
Evaluation criteria
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TEST group (kidney transplanted) | Kidney transplanted patients, passed through dialysis phase presenting a mandibular edentulism. It will be scheduled one or two dental implants to be inserted in mandible. This group will be subjected to a dental implant insertion procedure. |
| |
| CONTROL group (healthy patients) | Healthy patients, with an inserted mandibular implant, retrospectively enrolled with a preoperative cbct scan. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dental implant insertion | Procedure | Dental implant insertion will be carry out in the mandible of the patients enrolled, through a surgical template in order to repeat the same position of the simulating implant insertion. After a trephine bur passage, the final two or three twist-drills will be used to realize the implant socket. After implant positioning, a cover screw will be tightened and the mucosa sutured above. |
| Measure | Description | Time Frame |
|---|---|---|
| Bone density measured in Grey Value | bone density will be assessed on the cone beam CT scans with the virtual implant positioning before surgery (for the test group) and postoperatively (retrospectively assessed) for the control group. Grey Value will be assessed in the area of 1 mm around the shape of the implants. | seven days after cone beam computed tomography |
| Measure | Description | Time Frame |
|---|---|---|
| Insertional torque value | Only for the test group the Insertional torque value will be assessed during surgery. | during implant placement |
| Histomorphometric analysis | Only for the test group the microscopic analysis will be performed on the specimen harvested during surgery (via trephine bur, preparing the implant site) |
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Inclusion Criteria:
and for control
Exclusion Criteria:
and for control group
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The minimal number of the participants of this study is 26 per group: this results from the measure of a 0,8 effect size. If the effect size is less than 1 (minimal value), it represents the situation where the medium difference of standard deviations of the variable "bone density" is equivalent to the difference of the value between the two groups of the study.
Subject of test group will be enrolled an a kidney transplanted patients, while Subjects of control group will be enrolled retrospectively in healthy patients
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Federico Berton, DDS | Contact | 0403992254 | 0039 | fberton@units.it |
| Name | Affiliation | Role |
|---|---|---|
| Roberto Di Lenarda, DDS, MSc | University of Trieste Medical School, Department of Odontology and Stomatology | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Company, "Ospadale Maggiore" | Recruiting | Trieste | TS | 34100 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22251553 | Background | Arisan V, Karabuda ZC, Avsever H, Ozdemir T. Conventional multi-slice computed tomography (CT) and cone-beam CT (CBCT) for computer-assisted implant placement. Part I: relationship of radiographic gray density and implant stability. Clin Implant Dent Relat Res. 2013 Dec;15(6):893-906. doi: 10.1111/j.1708-8208.2011.00436.x. Epub 2012 Jan 17. | |
| 23104660 |
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| ID | Term |
|---|---|
| D016388 | Tooth Loss |
| D007674 | Kidney Diseases |
| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D014076 | Tooth Diseases |
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bone specimen harvested during implant site preparation in order to obtain usefull samples for hystomorphometrical analysis
|
| within 20 days after implant placement |
| Cassetta M, Stefanelli LV, Di Carlo S, Pompa G, Barbato E. The accuracy of CBCT in measuring jaws bone density. Eur Rev Med Pharmacol Sci. 2012 Oct;16(10):1425-9. |
| 23876979 | Background | Zou H, Zhao X, Sun N, Zhang S, Sato T, Yu H, Chen Q, Weber HP, Dard M, Yuan Q, Lanske B. Effect of chronic kidney disease on the healing of titanium implants. Bone. 2013 Oct;56(2):410-5. doi: 10.1016/j.bone.2013.07.014. Epub 2013 Jul 19. |
| D014570 |
| Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |