The Effect of Non-surgical Periodontal Treatment in the Renal Function of Patients With Chronic Kidney Disease: RCT

Study Overview
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Brief Summary
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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.

Official Title
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The Effect of Non-surgical Periodontal Treatment in the Renal Function of Patients With Chronic Kidney Disease: A Randomized Clinical Trial

Conditions
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Chronic Kidney Disease, Periodontitis

Intervention / Treatment
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* Procedure: Full Mouth Non-Surgical Periodontal Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Chronic Kidney Disease (Stage I, 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>Full mouth supra-gingival debridement using hand instruments and ultrasonic scalers, in one session. Patient motivation and oral hygiene instructions Review and prophylaxis at 1 month, 3 months and 6 months after initial treatment session. Full mouth periodontal therapy provided at the end of the 6month period (supra and sub- gingival full mouth scaling) | |
| Active Comparator: Test/ Non-surgical Periodontal Therapy<br>Full mouth periodontal therapy (sub and supra- gingival debridement) provided under local anaesthesia in two half-mouth sessions. Review and prophylaxis 1 month, 3 months and 6 months after the end of the initial therapy. | Procedure: Full Mouth Non-Surgical Periodontal Therapy<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| eGFR | estimated Glomerular Filtration Rate | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cystatin C | Surrogate marker for filtration rate | 6 months | 
| CRP |  | 6 months | 
| d-8-iso prostaglandin F2a |  | 6 months | 
| Level of IgG antibodies in serum against periodontal pathogens | 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 | 6 months | 
| Composition of dental plaque | 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 | 6 months | 
| Il-6 |  | 6 months | 
| TNF-α |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CKD, Renal, Chronic Kidney Disease, Periodontitis, Perio