CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 106 enrolled
Drug / intervention
Not specified
Likely dose
Not stated in record
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Search/NCT02547753
NCT02547753N/ACompleted

Clinical Outcome of Dental Extractions Among Renal Transplant Recipients

University of Sao Paulo·observational·Posted Sep 11, 2015·Updated Nov 28, 2018

In Brief

An observational study for Immunosuppression. Completed, enrolled 106 participants across 2 sites.

Detailed Summary

The literature is rich in studies that explore the type and frequency of oral abnormalities in transplanted recipients, but it is scarce in studies that provide scientific evidence on the risk of complications after invasive interventions on those patients. Within this context, the aim of our study is to evaluate the post-exodontic socket healing in renal transplant recipients compared to a control group and see if some indicators in the population of transplanted people, such complete blood count, serum concentration of immunosuppressive drugs, can help to provide for the host response face a invasive procedures. Therefore, 45 kidney transplant recipients over six months and at least 45 healthy non immunosuppressed adults will be submitted to a maximum of 4 simple dental extractions, always by the same surgeon. Laboratory tests will be performed preoperatively and include: blood count and coagulation - for both groups - and urea, creatinine and serum levels of immunosuppressive drug - only for the study group. Researchers will evaluate the patient in the postoperative 3, 7, 21, and 60 days. The presence, or absence, of post-operative complication and delayed, or not, socket healing will be the results of interest in this study and will be compared between the groups. The data will be evaluated by Pearson's chi-square, Fisher's exact test, Mann-Whitney test, student's T-test and binomial test.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesBrazil

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedSep 11, 2015
Enrollment StartOct 1, 2015
Primary CompletionJul 1, 2018
Study CompletionAug 31, 2018
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 10.8 years ago