Novel PAradigm to Improve Inflammatory Burden in ESRD (rePAIR): A Pilot and Feasibility Randomized Controlled Trial

End Stage Renal Disease Clinical Trial

— rePAIR  

Official title:

Pilot and Feasibility Clinical Research Grants in Kidney or Urologic Diseases (R21)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03241511
• Other study ID #: 16-111-1
• Secondary ID: R21DK108076
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 7, 2017
• Est. completion date: April 2021

Study information

• Verified date: January 2021
• Source: UConn Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 90
• Est. completion date: April 2021
• Est. primary completion date: April 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Periodontitis
• End Stage Renal Disease
• Kidney Diseases
• Kidney Failure, Chronic
• Periodontitis

Intervention

Other:
• Test
Briefly, treatment sessions will include oral hygiene behavioral modification and scaling and root planning (removing the bacterial biofilm and calculus below the gum line) in order to eliminate etiologic factors and control periodontal inflammation. Once the treatment sessions are completed, the patients will enter the maintenance phase and will be followed for 6 months. In this phase, the patients will receive systematic supportive periodontal treatment (tooth cleanings above the gum line with re-enforcement of oral hygiene).

Locations

Country	Name	City	State
United States	University of Connecticut Health Center	Farmington	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
UConn Health	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum CRP	Inflammatory markers	6 months
Secondary	Probing depth PD	Clinical periodontal outcome	6 months
Secondary	Clinical attachment levels CAL	Clinical periodontal outcome	6 months
Secondary	OHIP-14	Patient Centered Outcome	6 months
Secondary	Serum IL-6	Inflammatory Marker	6 months
Secondary	F2 isoprostanes	Oxidative Stress Marker	6 months
Secondary	isofurans	Oxidative Stress Marker	6 months