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Completed

NCT Number: NCT01217281

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

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.

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Key information

Conditions

Chronic Kidney Disease Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Mouth Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Periodontal Diseases Periodontitis Renal Insufficiency Renal Insufficiency, Chronic Stomatognathic Diseases Urogenital Diseases Urologic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Athens, Dental School, Department of Periodontology

Athens, 11527, Greece

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Full Mouth Non-Surgical Periodontal Therapy

Procedure

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

Primary outcomes

  1. eGFR

    Time frame: 6 months

    Estimated Glomerular Filtration Rate

Secondary outcomes

  1. CRP

    Time frame: 6 months

    C-Reactive Protein level

  2. d-8-iso prostaglandin F2a

    Time frame: 6 months

    d-8-iso prostaglandin F2a

  3. Level of IgG antibodies in serum against periodontal pathogens

    Time frame: 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

  4. Composition of dental plaque

    Time frame: 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

  5. HbA1C

    Time frame: 6 months

    Glycosylated Hemoglobin

  6. FMD / NMD

    Time frame: 6 months

    Flow Mediated Dialation, Nitroglycerin Mediated Dialation, Assessment of Endothelial Dysfunction

  7. PWV

    Time frame: 6 months

    Pass Wave Velocity, Assessment of Endothelial Dysfunction

  8. AIx

    Time frame: 6 months

    Augmentaion Index

  9. Cholesterol levels

    Time frame: 6 months

    Chloesterol Levels

  10. Ca

    Time frame: 6 months

    Serum Calcium

  11. P

    Time frame: 6 months

    Serum Phosphate

  12. Triglycerides

    Time frame: 6 months

    Serum triglycerides

  13. LDL / HDL

    Time frame: 6 months

    Low / High Density Lipoprotein

  14. Serum Urea

    Time frame: 6 months

    Serum Urea

  15. Serum Albumin

    Time frame: 6 months

    Serum Albumin

  16. Urine Albumin

    Time frame: 6 months

    Urine Albumin

  17. Urine Creatinine

    Time frame: 6 months

    Urine Creatinine

  18. Cr/Alb ratio

    Time frame: 6 months

    Urine Creatinine / Albumin Ration

Other outcomes

  1. Periodontal Indices (PPD, CAL, BOP, GI)

    Time frame: 6 months

    Assessment of the periodontal status

Sponsors and collaborators

Lead sponsor

University of Athens

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2022
Study completion
2022
First posted
Oct 8, 2010
Registry last updated
Jul 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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