Tooth Loss Clinical Trial
Official title:
Peri-Implant Bone Assessment in Transplanted Patients: A Case Control Study
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.
Status | Recruiting |
Enrollment | 26 |
Est. completion date | August 2022 |
Est. primary completion date | May 2020 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Diagnosis: single or partial mandibular molar-premolar edentulism that requires up to 2 fixtures - Good systemic compensation of the kidney transplant (= ASA American Society of Anesthesiologists score 3) with at least 1 year of previous hemodialysis or peritoneal dialysis and in actual immunosuppressive therapy - Be older than 18 years - The patient must be able to understand the meaning of the study and accept to undergo periodical follow-up controls. - The patient must be able to understand and practice all the oral hygiene procedures demanded by the experimenter - Signature of the informed consent form and for control - Diagnosis: single or partial mandibular molar-premolar edentulism that requires up to 2 fixtures - Having a pre-operatory cone beam CT available - Age older than 18 years - Signature of the authorization to use and process personal details at the acceptance of every sort of treatment in the Company Hospital of Trieste. Exclusion Criteria: - Post extraction implant (before 3 months from the extraction) - Be less than 18 years old - Smoking more than 10 cigarettes/day - Plaque index more than 25 - Bleeding on probe index more than 25 - Clear allergy or intolerance against the products used in the study - Patients that require reconstructive bone surgery before the fixtures placement (gbr and bone grafting) and for control group - Patients that require reconstructive bone surgery before the fixtures placement (gbr and bone grafting) - Pathologies and pharmacological therapies that interfere with bone (for instance osteoporosis, osteomalacia, malnutrition, Paget's disease, corticosteroid therapy, bisphosphonate therapy, head and neck radiotherapy) |
Observational Model: Case Control, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Italy | University Hospital Company, "Ospadale Maggiore" | Trieste | TS |
Lead Sponsor | Collaborator |
---|---|
University of Trieste |
Italy,
Arisan V, Karabuda ZC, Avsever H, Özdemir 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. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Yes |
Secondary | Insertional torque value | Only for the test group the Insertional torque value will be assessed during surgery. | during implant placement | Yes |
Secondary | 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) | within 20 days after implant placement | Yes |
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