Chronic Kidney Disease, Periodontitis
Conditions
Keywords
CKD, Renal, Chronic Kidney Disease, Periodontitis, Perio
Brief summary
Periodontal disease is a bacterially-induced inflammation. As such, it can become a point of entry of bacteria, toxins and cytokines into the systemic blood circulation, thus adversely affecting the function of kidneys. This is turn can aggravate the condition of patients with CKD. The study hypothesis is that periodontal therapy can improve renal function in patients with CKD and lower the blood levels of markers for systemic inflammation.
Interventions
PROCEDUREFull Mouth Non-Surgical Periodontal Therapy
Non-surgical Periodontal Therapy provided in two sessions, one for the right half and one for the left half of the dentition. Treatment sessions are provided within one week. No antibiotics or other adjunctive medications are to be used
Sponsors
University of Athens
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Chronic Kidney Disease (Stage II, III, IV) * At least 12 teeth present in the oral cavity * Moderate to severe chronic periodontitis, which is defined as: at least 8 surfaces with periodontal pocket depth (PPD) ≥5mm and at least 4 surfaces with Clinical Attachment Loss (CAL) ≥4mm, distributed in at least two quadrants.
Exclusion criteria
* Patients that have had a renal transplant or undergoing dialysis * Acute infections or use of antibiotics in the past 3 months. * Auto-immune diseases, conditions that cause immunosuppression or use of immunosuppressant medication. * Systemic conditions that require antibiotic prophylaxis for routine periodontal therapy. * Non-surgical periodontal therapy in the past 6 months or surgical periodontal therapy in the past 12 months. * Use of medication that can cause gingival hyperplasia such as cyclosporine or fenintoin. * Myocardial infarction or cerebral vascular incident in the past 12 months or uncontrolled angina.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| eGFR | 6 months | Estimated Glomerular Filtration Rate |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PWV | 6 months | Pass Wave Velocity, Assessment of Endothelial Dysfunction |
| CRP | 6 months | C-Reactive Protein level |
| d-8-iso prostaglandin F2a | 6 months | d-8-iso prostaglandin F2a |
| Level of IgG antibodies in serum against periodontal pathogens | 6 months | Serum samples will be screened for the presence of IgG antibodies against the below mentioned periodontal pathogens, using the checkerboard immunoblotting method: Porphyromonas gingivalis, Prevotella intermedia, Prevotella nigrescens, Bacteroides forsythus, Treponema denticola, Fusobacterium nucleatum, Actinobacillus actinomycetemcomitans, Campylobacter rectus, Eikenella corrodens, Peptostreptococcus micros, Veillonella parvula, Capnocytophaga ochracea, Streptococcus intermedius, Streptococcus sanguis και Streptococcus oralis.per |
| Composition of dental plaque | 6 months | Samples of subgingival plaque will be assessed using DNA probes according to the checkerboard DNA- DNA hybridization method. DNA probes will be used against the following bacteria: Porphyromonas gingivalis, Prevotella intermedia, Prevotella nigrescens, Bacteroides forsythus, Treponema denticola, Fusobacterium nucleatum, Actinobacillus actinomycetemcomitans, Campylobacter rectus, Eikenella corrodens, Peptostreptococcus micros, Veillonella parvula, Capnocytophaga ochracea, Streptococcus intermedius, Streptococcus sanguis and Streptococcus oralis |
| HbA1C | 6 months | Glycosylated Hemoglobin |
| FMD / NMD | 6 months | Flow Mediated Dialation, Nitroglycerin Mediated Dialation, Assessment of Endothelial Dysfunction |
| AIx | 6 months | Augmentaion Index |
| Cholesterol levels | 6 months | Chloesterol Levels |
| P | 6 months | Serum Phosphate |
| Triglycerides | 6 months | Serum triglycerides |
| LDL / HDL | 6 months | Low / High Density Lipoprotein |
| Serum Urea | 6 months | Serum Urea |
| Serum Albumin | 6 months | Serum Albumin |
| Urine Albumin | 6 months | Urine Albumin |
| Urine Creatinine | 6 months | Urine Creatinine |
| Cr/Alb ratio | 6 months | Urine Creatinine / Albumin Ration |
| Ca | 6 months | Serum Calcium |
Other
| Measure | Time frame | Description |
|---|---|---|
| Periodontal Indices (PPD, CAL, BOP, GI) | 6 months | Assessment of the periodontal status |
Countries
Greece
Outcome results
None listed