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CompletedNCT01217281Updated Jul 24, 2025

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

An interventional study of Full Mouth Non-Surgical Periodontal Therapy in Chronic Kidney Disease and Periodontitis, sponsored by University of Athens. Completed at 1 site in Greece. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-07-24.

Sponsored by University of Athens · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Chronic Kidney Disease
  • Periodontitis

Keywords

  • CKD, Renal, Chronic Kidney Disease, Periodontitis, Perio
03

In context

Renal Insufficiency, Chronic

3,144 studies on the registry are indexed under Renal Insufficiency, Chronic; 704 are open to participants now.

This study's enrollment of 60 is below the median of 74 across 2,176 interventional studies indexed under Renal Insufficiency, Chronic.

Browse Renal Insufficiency, Chronic studies →

Lead sponsor

University of Athens is the lead sponsor of 133 studies on the registry; 19 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts 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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
60 participants (actual)

Study arms

  • No intervention
    Control

    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

    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

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

06

What researchers measure

Primary outcomes

  1. eGFR

    Estimated Glomerular Filtration Rate

    Time frame: 6 months

Secondary outcomes

  1. CRP

    C-Reactive Protein level

    Time frame: 6 months

  2. d-8-iso prostaglandin F2a

    d-8-iso prostaglandin F2a

    Time frame: 6 months

  3. 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

    Time frame: 6 months

  4. 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

    Time frame: 6 months

  5. HbA1C

    Glycosylated Hemoglobin

    Time frame: 6 months

  6. FMD / NMD

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

    Time frame: 6 months

  7. PWV

    Pass Wave Velocity, Assessment of Endothelial Dysfunction

    Time frame: 6 months

  8. AIx

    Augmentaion Index

    Time frame: 6 months

  9. Cholesterol levels

    Chloesterol Levels

    Time frame: 6 months

  10. Ca

    Serum Calcium

    Time frame: 6 months

  11. P

    Serum Phosphate

    Time frame: 6 months

  12. Triglycerides

    Serum triglycerides

    Time frame: 6 months

  13. LDL / HDL

    Low / High Density Lipoprotein

    Time frame: 6 months

  14. Serum Urea

    Serum Urea

    Time frame: 6 months

  15. Serum Albumin

    Serum Albumin

    Time frame: 6 months

  16. Urine Albumin

    Urine Albumin

    Time frame: 6 months

  17. Urine Creatinine

    Urine Creatinine

    Time frame: 6 months

  18. Cr/Alb ratio

    Urine Creatinine / Albumin Ration

    Time frame: 6 months

Other outcomes

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

    Assessment of the periodontal status

    Time frame: 6 months

07

Study locations

1 site
  • University of Athens, Dental School, Department of Periodontology
    Athens, 11527, Greece
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 24, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01217281
Lead sponsor
University of Athens
Responsible party
Spyros Kouris (Spyros Kouris, DIpDS, MClinDent, PhD Candidate, University of Athens) — Principal investigator
First posted
Oct 8, 2010
Start date
Jan 30, 2012
Primary completion
Jan 12, 2022
Completion
Jun 18, 2022
Last update
Jul 24, 2025

Study contacts

Phoebus N Madianos, PhD
principal investigator · University of Athens

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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