The Effect of Non-surgical Periodontal Treatment in the Renal Function of Patients With Chronic Kidney Disease: RCT
- Conditions
- PeriodontitisChronic Kidney Disease
- Interventions
- Procedure: Full Mouth Non-Surgical Periodontal Therapy
- Registration Number
- NCT01217281
- Lead Sponsor
- University of Athens
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 48
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Test/ Non-surgical Periodontal Therapy Full Mouth Non-Surgical Periodontal Therapy 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.
- Primary Outcome Measures
Name Time Method eGFR 6 months estimated Glomerular Filtration Rate
- Secondary Outcome Measures
Name Time Method CRP 6 months d-8-iso prostaglandin F2a 6 months Il-6 6 months TNF-α 6 months Cystatin C 6 months Surrogate marker for filtration rate
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
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
Trial Locations
- Locations (1)
University of Athens, Dental School, Department of Periodontology
🇬🇷Athens, Greece