Osseointegrated Dental Implants in Kidney Transplanted Patients
Italy26 participantsStarted 2014-05
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 graftin…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Bone density measured in Grey Value
Timeframe: seven days after cone beam computed tomography