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

Primary Purpose

Chronic Kidney Disease, Periodontitis

Status
Completed
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
Full Mouth Non-Surgical Periodontal Therapy
Sponsored by
University of Athens
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Kidney Disease focused on measuring CKD, Renal, Chronic Kidney Disease, Periodontitis, Perio

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Athens, Dental School, Department of Periodontology

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

Control

Test/ Non-surgical Periodontal Therapy

Arm Description

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)

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.

Outcomes

Primary Outcome Measures

eGFR
estimated Glomerular Filtration Rate

Secondary Outcome Measures

Cystatin C
Surrogate marker for filtration rate
CRP
d-8-iso prostaglandin F2a
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
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
Il-6
TNF-α

Full Information

First Posted
October 6, 2010
Last Updated
October 9, 2023
Sponsor
University of Athens
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1. Study Identification

Unique Protocol Identification Number
NCT01217281
Brief Title
The Effect of Non-surgical Periodontal Treatment in the Renal Function of Patients With Chronic Kidney Disease: RCT
Official Title
The Effect of Non-surgical Periodontal Treatment in the Renal Function of Patients With Chronic Kidney Disease: A Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
June 2010 (undefined)
Primary Completion Date
January 12, 2022 (Actual)
Study Completion Date
May 18, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Athens

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease, Periodontitis
Keywords
CKD, Renal, Chronic Kidney Disease, Periodontitis, Perio

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
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)
Arm Title
Test/ Non-surgical Periodontal Therapy
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Full Mouth Non-Surgical Periodontal Therapy
Intervention Description
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 Outcome Measure Information:
Title
eGFR
Description
estimated Glomerular Filtration Rate
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Cystatin C
Description
Surrogate marker for filtration rate
Time Frame
6 months
Title
CRP
Time Frame
6 months
Title
d-8-iso prostaglandin F2a
Time Frame
6 months
Title
Level of IgG antibodies in serum against periodontal pathogens
Description
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
Title
Composition of dental plaque
Description
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
Title
Il-6
Time Frame
6 months
Title
TNF-α
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Phoebus N Madianos, PhD
Organizational Affiliation
University of Athens
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Athens, Dental School, Department of Periodontology
City
Athens
ZIP/Postal Code
11527
Country
Greece

12. IPD Sharing Statement

Learn more about this trial

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

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