Novel PAradigm to improve Inflammatory burden in end stage Renal disease (rePAIR): study protocol for a randomized controlled trial.

BACKGROUND: Given the importance of inflammation as a predictor of poor outcomes in End Stage Renal Disease (ESRD), reductions in inflammatory biomarkers have been proposed as a critical target in this population. This study targets chronic periodontitis, an oral inflammatory disease of microbial etiology causing persistent inflammation in ESRD. Unlike the previously reported episodic periodontal interventions, we propose to control periodontal inflammation with a continuous maintenance and oral health behavior modifications. We hypothesize that this strategy will improve systemic inflammation and oxidative stress, oral health and quality of life within the 6-month observation period. METHODS: The rePAIR (novel PAradigm to improve Inflammatory burden in ESRD) study is a pilot and feasibility, parallel-arm, and randomized controlled clinical trial that will recruit 72 ESRD subjects with periodontitis in a model of computerized block randomization. This trial aims to compare the effect of standard-of-care vs. repeated non-surgical periodontal therapy on systemic and oral inflammatory burden. This trial will recruit ESRD adult patients with periodontitis older than 21 years old with a minimum of 12 teeth and no history of periodontal treatment within a year. The trial will examine serum C-reactive protein (CRP) (primary outcome) as a biomarker of inflammation as well as interleukin-6 (IL-6), F2 isofurans and F2 isoprostanes (secondary outcomes) and compare their difference between groups from baseline to 6 months. The trial will also compare the difference between groups in patient-centered and clinical oral outcomes from baseline to 6 months. DISCUSSION: The trial follows a rigorous and transparent study design capturing elements such as pre-specified eligibility criteria, pre-specified primary and secondary outcomes, detailed intervention description to allow replication, intervention random allocation and concealment, blinding in outcome assessment, appropriate sample size calculations, explanation of interim analysis, as per CONSORT Guidelines. Further, gender diversity is secured not only at recruitment but also throughout the trial and during the analysis. Therefore, treatment response outcomes will be examined per gender category. In order to manage anticipated problems, the protocol has included alternative approaches. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03241511 . Registered on 7 August 2017.

Dental students' attitudes toward treating diverse patients: effects of a cross-cultural patient-instructor program.

This article describes the effects of a cross-cultural patient-instructor (PI) program on dental students' attitudes toward diversity. PIs were individuals from the community trained to portray specific simulated patients who presented cross-cultural challenges to students. Dental students interviewed PIs during two rotations, one in their junior and one in their senior year. Using a retrospective pretest-posttest design, after completing each rotation, students reported their likelihood of engaging in certain desirable diversity thoughts and actions before versus after each PI rotation. Seventy-three students completed the first cross-cultural rotation, and eighty-two students completed the second. Each rotation improved students' diversity-related attitudes. The first rotation, in their junior year, had slightly greater effect on these outcomes than the second rotation, in their senior year. Students also reported very positive evaluations of the course. These findings suggest that students' attitudes toward diversity can be modified. PIs are a creative way to promote cross-cultural patient care with health professions students, making them more open to thinking about, discussing, and engaging in patient-oriented, diversity-related activities.