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

Chronic Kidney Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01217281
• Other study ID #: 143
• Status: Completed
• Phase: N/A
• Start date: June 2010
• Est. completion date: May 18, 2022

Study information

• Verified date: October 2023
• Source: University of Athens
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: May 18, 2022
• Est. primary completion date: January 12, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Kidney Diseases
• Periodontitis
• Renal Insufficiency, Chronic

Intervention

Procedure:
• Full 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

Locations

Country	Name	City	State
Greece	University of Athens, Dental School, Department of Periodontology	Athens

Sponsors (1)

Lead Sponsor	Collaborator
University of Athens

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	eGFR	estimated Glomerular Filtration Rate	6 months
Secondary	Cystatin C	Surrogate marker for filtration rate	6 months
Secondary	CRP		6 months
Secondary	d-8-iso prostaglandin F2a		6 months
Secondary	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 ?a? Streptococcus oralis.per	6 months
Secondary	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
Secondary	Il-6		6 months
Secondary	TNF-a		6 months