Clinical trial NCT03241511: Novel PAradigm to Improve Inflammatory Burden in ESRD (rePAIR): A Pilot and Feasibility Randomized Controlled Trial
Official title: Pilot and Feasibility Clinical Research Grants in Kidney or Urologic Diseases (R21)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Periodontitis
End Stage Renal Disease
Keywords: Periodontitis, End Stage Renal Disease, Periodontal treatment
Lead sponsor: UConn Health
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2017-08-07
Enrollment: 66
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this project is to assess repeated and ongoing oral care and the way it may affect inflammation and quality of life in hemodialysis patients. Two treatment groups will be compared:

* 1) ongoing and repeated gum disease therapy including deep tooth cleaning followed by multiple appointments of maintenance
* 2) single session of gum disease therapy with only one session of deep tooth cleaning Samples of blood will be obtained for study to examine the changes of inflammatory substances in the blood as a result of the two different gum disease treatments. Also, a 14-question survey will be discussed with you to assess oral health related quality of life (OHIP-14) and the way it is affected by oral care.

For this project, four dialysis centers will be randomly assigned to either of the treatment groups #1 or #2 prior to your enrollment. For this purpose, there are two distinct consent forms explaining the visits, procedures and risks of the two treatment groups #1 or #2. As a result, all participants in the same dialysis center will belong to the same treatment group (either #1 or #2) and presented with the corresponding consent form.

This dialysis center has been randomized to treatment group # 1; therefore you will receive ongoing and repeated gum disease therapy including deep tooth cleaning followed by multiple appointments of maintenance.


Eligibility criteria: Inclusion Criteria:

* Patient must be referred by nephrologist
* Patient must be diagnosed with ESRD and on Hemodialysis
* life expectancy more than one year
* at least 21 years of age
* 12 or more teeth
* must meet the Periodontal diagnosis criteria (The diagnosis of periodontitis is based on the definition of moderate periodontitis with at least 2 sites with CAL≥4mm or at least 2 sites with PD≥5mm not on the same tooth (Page and Eke 2007).)

Exclusion Criteria:

* Anticipating a kidney transplant
* AIDS
* Active malignancy
* Poor adherence to hemodialysis
* Dementia
* Currently prescribed anti-inflammatory medication
* Temporary catheter for dialysis access
* Gum disease treatment within the last year

Primary outcomes:
measure: Serum CRP
timeFrame: 6 months
Secondary outcomes:
measure: Probing depth PD
timeFrame: 6 months
measure: Clinical attachment levels CAL
timeFrame: 6 months
measure: OHIP-14
timeFrame: 6 months
measure: Serum IL-6
timeFrame: 6 months
measure: F2 isoprostanes
timeFrame: 6 months
measure: isofurans
timeFrame: 6 months
Other outcomes:
Locations:
city: Farmington
country: United States
facility: University of Connecticut Health Center
state: Connecticut
Study officials:
affiliation: UConn Health
name: Effie Ioannidou, DDS, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Trivedi R, Fares G, Nunez VB, Campbell R, Clement M, Burleson J, Himmelfarb J, Ioannidou E. Novel PAradigm to improve Inflammatory burden in end stage Renal disease (rePAIR): study protocol for a randomized controlled trial. Trials. 2018 Jul 11;19(1):370. doi: 10.1186/s13063-018-2760-y.