Chronic Periodontitis, End Stage Renal Disease
Conditions
Keywords
Periodontitis, End Stage Renal Disease, Periodontal 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.
Interventions
OTHERTest
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).
Sponsors
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
UConn Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serum CRP | 6 months | Inflammatory markers |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical attachment levels CAL | 6 months | Clinical periodontal outcome |
| OHIP-14 | 6 months | Patient Centered Outcome |
| Probing depth PD | 6 months | Clinical periodontal outcome |
| F2 isoprostanes | 6 months | Oxidative Stress Marker |
| isofurans | 6 months | Oxidative Stress Marker |
| Serum IL-6 | 6 months | Inflammatory Marker |
Countries
United States
Outcome results
None listed