Chronic Kidney DiseaseNCT01217281
The Effect of Non-surgical Periodontal Treatment in the Renal Function of Patients With Chronic Kidney Disease: RCT
A study testing Full Mouth Non-Surgical Periodontal Therapy in people with Chronic Kidney Disease and Periodontitis, run by University of Athens at 1 site in Greece.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronic Kidney Disease, Periodontitis
- What is being tested?
- Full Mouth Non-Surgical Periodontal Therapy
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteGreece
- Study dates
- 30 Jan 2012to 18 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Greece1 site
University of Athens, Dental School, Department of Periodontology
Athens, 11527
About this study
Official title: The Effect of Non-surgical Periodontal Treatment in the Renal Function of Patients With Chronic Kidney Disease: A Randomized Clinical Trial
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.
- Conditions
- Chronic Kidney Disease, Periodontitis
- Being tested
- Full Mouth Non-Surgical Periodontal Therapy
- Keywords
- CKD, Renal, Chronic Kidney Disease, Periodontitis, Perio
- Medical subject headings
- Renal Insufficiency, Chronic, Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Full Mouth Non-Surgical Periodontal TherapyProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | 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) |
| Test/ Non-surgical Periodontal Therapy | Active comparator | 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. Receives: Procedure: Full Mouth Non-Surgical Periodontal Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
eGFR
Estimated Glomerular Filtration Rate
Measured: 6 months
Secondary outcomes (18)
CRP
C-Reactive Protein level
Measured: 6 months
d-8-iso prostaglandin F2a
d-8-iso prostaglandin F2a
Measured: 6 months
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
Measured: 6 months
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
Measured: 6 months
HbA1C
Glycosylated Hemoglobin
Measured: 6 months
FMD / NMD
Flow Mediated Dialation, Nitroglycerin Mediated Dialation, Assessment of Endothelial Dysfunction
Measured: 6 months
PWV
Pass Wave Velocity, Assessment of Endothelial Dysfunction
Measured: 6 months
AIx
Augmentaion Index
Measured: 6 months
Cholesterol levels
Chloesterol Levels
Measured: 6 months
Ca
Serum Calcium
Measured: 6 months
P
Serum Phosphate
Measured: 6 months
Triglycerides
Serum triglycerides
Measured: 6 months
LDL / HDL
Low / High Density Lipoprotein
Measured: 6 months
Serum Urea
Serum Urea
Measured: 6 months
Serum Albumin
Serum Albumin
Measured: 6 months
Urine Albumin
Urine Albumin
Measured: 6 months
Urine Creatinine
Urine Creatinine
Measured: 6 months
Cr/Alb ratio
Urine Creatinine / Albumin Ration
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2010 (estimated)
- Study start30 Jan 2012
- Primary completion12 Jan 2022
- Study completion18 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Athens
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Spyros Kouris, University of Athens
- Investigators
- Phoebus N Madianos, PhD, Principal investigator, University of Athens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01217281
- Sponsor's protocol ID
- 143
- Status last verified
- Jul 2025
- First submitted
- 6 Oct 2010
- Last updated
- 24 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Non-surgical Periodontal Treatment in the Renal Function of Patients With Chronic Kidney Disease: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT01217281
- Acronym / sponsor ID
- 143
- Conditions
- Chronic Kidney Disease, Periodontitis
- Keywords
- CKD, Renal, Chronic Kidney Disease, Periodontitis, Perio
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of AthensUniversity, hospital or other
- Study start
- 30 Jan 2012 (actual)
- Primary completion
- 12 Jan 2022 (actual)
- Study completion
- 18 Jun 2022 (actual)
- First posted
- 8 Oct 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –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) |
| Test/ Non-surgical Periodontal Therapy | Active comparator | Procedure: Full Mouth Non-Surgical Periodontal TherapyFull 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Full Mouth Non-Surgical Periodontal TherapyNon-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 | Procedure or surgery | Test/ Non-surgical Periodontal Therapy |
Primary outcome
eGFR
Time frame: 6 months
Estimated Glomerular Filtration Rate
18 secondary outcomes
CRP
Time frame: 6 months
d-8-iso prostaglandin F2a
Time frame: 6 months
Level of IgG antibodies in serum against periodontal pathogens
Time frame: 6 months
Composition of dental plaque
Time frame: 6 months
HbA1C
Time frame: 6 months
FMD / NMD
Time frame: 6 months
PWV
Time frame: 6 months
AIx
Time frame: 6 months
Cholesterol levels
Time frame: 6 months
Ca
Time frame: 6 months
P
Time frame: 6 months
Triglycerides
Time frame: 6 months
LDL / HDL
Time frame: 6 months
Serum Urea
Time frame: 6 months
Serum Albumin
Time frame: 6 months
Urine Albumin
Time frame: 6 months
Urine Creatinine
Time frame: 6 months
Cr/Alb ratio
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Phoebus N Madianos, PhD principal investigator
University of Athens
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Full Mouth Non-Surgical Periodontal Therapy in people with Chronic Kidney Disease and Periodontitis, run by University of Athens at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
eGFR (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2025.