Osseointegrated Dental Implants in Kidney Transplanted Patients
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|ClinicalTrials.gov Identifier: NCT02513602|
Recruitment Status : Recruiting
First Posted : July 31, 2015
Last Update Posted : November 2, 2016
|Condition or disease||Intervention/treatment|
|Tooth Loss Disorder Related to Renal Transplantation||Procedure: Dental implant insertion|
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.
- Control group: evaluation of the periimplant bone density (1 mm) next to the implant virtually planned using the CT editing software on the cone beam CT acquired in a retrospective sample of patients already treated with the insertion of a fixture in the molar or premolar edentulous site
- Test group: periodontal evaluation with plaque index, bleeding on probing index and probing 1 month before operation.
- Test group: evaluation of periimplant bone density (1 mm) in the fixture virtual-projected zone (the implant will be inserted there) with the CT acquisition and editing software.
- Test group: evaluation of the implant stability after their insertion (primary stability) using the Resonance Frequence Analysis. ISQ (Implant Stability Quotient) value is expressed in 4 numbers (mesial, distal, buccal, lingual), average values of three measures acquired in each side.
- Test group: evaluation of the implant stability immediately after the insertion calculating the insertional torque value (ITV) with an implant motor.
- Test group: evaluation of the periimplant bone using an endoral periapical radiograph with Rinn device immediately after the operation.
- Test group: histomorphological examination of the bone core sample made by a trephine resulted from the implant site preparation
|Study Type :||Observational|
|Estimated Enrollment :||26 participants|
|Observational Model:||Case Control|
|Official Title:||Peri-Implant Bone Assessment in Transplanted Patients: A Case Control Study|
|Study Start Date :||May 2014|
|Estimated Primary Completion Date :||May 2020|
|Estimated Study Completion Date :||August 2022|
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.
Procedure: Dental implant insertion
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.
CONTROL group (healthy patients)
Healthy patients, with an inserted mandibular implant, retrospectively enrolled with a preoperative cbct scan.
- Bone density measured in Grey Value [ Time Frame: seven days after cone beam computed tomography ]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.
- Insertional torque value [ Time Frame: during implant placement ]Only for the test group the Insertional torque value will be assessed during surgery.
- Histomorphometric analysis [ Time Frame: within 20 days after implant placement ]Only for the test group the microscopic analysis will be performed on the specimen harvested during surgery (via trephine bur, preparing the implant site)
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02513602
|Contact: Federico Berton, DDS||0403992254 ext email@example.com|
|University Hospital Company, "Ospadale Maggiore"||Recruiting|
|Trieste, TS, Italy, 34100|
|Contact: Federico Berton, DDS 0403992254 ext 0039 firstname.lastname@example.org|
|Contact: Gaetano Castronovo, MS, Msc 0403992254 ext 0039 email@example.com|
|Study Director:||Roberto Di Lenarda, DDS, MSc||University of Trieste Medical School, Department of Odontology and Stomatology|