AzTrials
AzTrials

Chronic Kidney DiseaseNCT07635797

Effectiveness of Subgingival Instrumentation on Delaying End-stage Renal Disease Among Chronic Kidney Disease Patients

A study testing Subgingival Instrumentation and Oral Hygiene Instructions in people with Chronic Kidney Disease and Periodontitis, run by Postgraduate Institute of Dental Sciences Rohtak at 1 site in India.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

Chronic kidney disease (CKD) and periodontitis share a bidirectional inflammatory relationship, with cytokines such as IL-6, TNF-α, and hsCRP driving progression in both conditions. Read more about this study

Who is it for?
Ages 40 to 70 years
What is being tested?
Subgingival Instrumentation and Oral Hygiene Instructions
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteIndia
Study dates
Jul 2026to Dec 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

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 40 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients aged 40-70 years.
  • Type 2 diabetes mellitus with chronic kidney disease and currently on oral hypoglycaemic agents.
  • Diagnosed with Stage IV or V (eGFR between 15-20 mL/min/1.73m²).
  • Not undergoing dialysis.
  • Presence of ≥20 natural teeth.
  • Diagnosed with moderate (Stage II) (as per 2017 World Workshop classification) (Interdental CAL at site of greatest loss >2mm but <5 mm in ≥ 2 non-adjacent teeth).
  • Willingness to provide written informed consent.

Who cannot join

  • Patients already undergoing haemodialysis or renal transplantation.
  • Patients on insulin therapy or taking SGLT2 inhibitors and GLP-1 receptor agonists.
  • HbA1c level >8 %.
  • Any Periodontal therapy within past 6 months.
  • Immunocompromised patients.
  • Any history of tobacco use.
  • Pregnant or lactating women.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

India1 site
  • Post Graduate Institute of Dental Sciences , Rohtak

    Rohtak, Haryana, 124001

    Gurleen Kaur, MDS, 9354031553, drgurleenphd@gmail.com

    Vipul Yadav, MDS, 8826363961, vipulyadavv.97@gmail.com

Other trials in India

About this study

Official title: Effectiveness of Subgingival Instrumentation on Delaying End-stage Renal Disease Among Chronic Kidney Disease Patients: A Non-Randomized Clinical Study

Chronic kidney disease (CKD) and periodontitis share a bidirectional inflammatory relationship, with cytokines such as IL-6, TNF-α, and hsCRP driving progression in both conditions. Non-surgical periodontal therapy (NSPT) has shown reductions in systemic inflammatory markers with emerging evidence of improved renal function, yet robust randomized controlled trials targeting pre-dialysis stage IV-V diabetic CKD patients remain lacking. In the Indian context, where diabetes-related CKD is rapidly rising and access to dialysis is limited, there is a clear lacuna in literature regarding the effectiveness of NSPT in delaying progression to end-stage renal disease. Hence, the present non-randomized clinical study is undertaken to address this gap.

Read the detailed description

Chronic kidney disease (CKD) is a major socio-economic and healthcare problem and represents a significant global public health challenge. The burden of disease is disproportionately higher in low- and middle-income countries. As per the Global Burden of Disease (GBD) 2023 estimates, approximately 788 million people were affected by CKD globally, with a global age-adjusted prevalence of 14.2% among adults aged 20 years and older. CKD has a significant global burden, affecting over 9% of the world population and was directly responsible for 1.2 million deaths worldwide in 2017 alone.

Chronic kidney disease is defined as the presence of kidney damage or an estimated glomerular filtration rate (eGFR) of less than 60 ml/min/1.73 m² persisting for three months or more, irrespective of the underlying cause. It represents a state of progressive loss of kidney function, ultimately resulting in the need for renal replacement therapy in the form of dialysis or kidney transplantation. Kidney damage refers to pathological abnormalities detected by imaging or renal biopsy, abnormalities in urinary sediment, or increased urinary albumin excretion rates.

The leading cause of CKD is diabetes mellitus, followed by hypertension and glomerular diseases. The prevalence of individuals with CKD due to type 1 diabetes has continued to increase globally, rising by 21.7% between 2007 and 2017 and reaching approximately 3.2 million individuals in 2017. These individuals are at increased risk of cardiovascular complications, and nearly 25-30% progress to kidney failure. Irrespective of the initial nephropathy, once a critical mass of nephrons is lost, kidney disease generally follows a progressive course toward advanced stages, resulting in increased morbidity and mortality.

The burden of CKD arises not only from the management of end-stage renal disease but also from complications related to CKD and its associated comorbidities. There are effective strategies to reduce the rate of CKD progression and improve patient outcomes; therefore, the need for therapies aimed at slowing disease progression is critical.

Periodontal bacteria, which cause chronic inflammation and the breakdown of tooth-supporting structures, are the cause of periodontal disease, a chronic infectious oral illness. One of the most prevalent oral illnesses worldwide is periodontitis, affecting almost 20-50% of the global population in varying degrees, and the percentage rises with advancing age. In India, 51% of people had periodontal disease overall. Periodontal disease is implicated as an independent risk factor for CKD. Periodontitis is defined as an inflammatory disease of the supporting tissues of the teeth caused by specific microorganisms or groups of microorganisms, resulting in progressive destruction of the periodontal ligament and alveolar bone, with periodontal pocket formation, gingival recession, or both.

Chronic kidney disease and periodontal disease are strongly interconnected through shared inflammatory, metabolic, and immune pathways. Periodontal disease has been implicated as an independent risk factor for CKD and may also act as a risk factor for several acquired systemic diseases. The bidirectional relationship between periodontal disease and systemic conditions highlights the importance of oral health assessment in medically compromised populations.

Inflammation is defined as the tissue's biological response to harmful stimuli such as pathogens or irritants. Chronic inflammation and elevated inflammatory markers play a crucial role in the progression and adverse outcomes of CKD. Evidence from previous studies demonstrates that declining renal function is associated with increased levels of circulating inflammatory cytokines. Several investigations have proposed that chronic dental infections, particularly periodontal disease, contribute significantly to the systemic inflammatory burden observed in CKD patients. The pathophysiological concept of periodontitis involves the systemic dissemination of inflammatory mediators such as CRP, IL-6, and tumor necrosis factor-α (TNF-α), either due to local bacterial infection causing periodontal tissue destruction or through the systemic spread of periodontal pathogens and their endotoxins. Periodontitis, being a chronic inflammatory condition, may significantly amplify the existing systemic inflammatory burden in CKD, thereby contributing to disease progression and associated complications.

Periodontal infections worsen the systemic inflammatory status, leading to poor renal outcomes in CKD patients. Improving oral health care through non-surgical periodontal therapy may improve the systemic inflammatory status and renal function. Various studies demonstrated elevated levels of CRP and IL-6 in patients with periodontal disease and their significant reduction following non-surgical periodontal therapy (NSPT). These findings suggest that periodontal intervention may play a role in modulating systemic inflammation.

In the Indian context, where the prevalence of diabetes and CKD is increasing rapidly and access to dialysis remains limited for a large proportion of the population, strategies aimed at delaying progression to end-stage renal disease are of particular importance. Oral health is often neglected in medically compromised individuals, and periodontal disease frequently remains untreated. Addressing periodontal health may therefore represent an overlooked yet impactful component of comprehensive CKD care.

Thus, the present non-randomized controlled study is designed to evaluate the effectiveness of subgingival instrumentation in delaying the progression to end-stage renal disease or the initiation of dialysis among diabetic patients with stage IV chronic kidney disease. By assessing both periodontal and renal parameters over a defined follow-up period of 12 months, this study aims to generate evidence supporting the integration of periodontal care into the comprehensive management of diabetic CKD patients.

Being tested
Subgingival Instrumentation, Oral Hygiene Instructions
Keywords
Chronic Kidney Disease, Subgingival Instrumentation, Periodontitis, End Stage Renal Disease, Dialysis
Medical subject headings
Renal Insufficiency, Chronic, Periodontitis, Kidney Failure, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Subgingival InstrumentationProcedure or surgery

    Participants will receive subgingival instrumentation using an ultrasonic scaler (NSK Variose 2 Ultrasonic Scaler) and hand instruments (Sickle scalers and Curettes, GDC) followed by oral hygiene instructions (OHI).

  • Oral Hygiene InstructionsOther

    Participants will receive basic oral hygiene instructions

Study groups in NCT07635797
Study groupRoleWhat they receive
Intervention GroupExperimentalIntervention Group participants will receive subgingival instrumentation using an ultrasonic scaler (NSK Variose 2 Ultrasonic Scaler) and hand instruments (Sickle scalers and Curettes, GDC) followed by oral hygiene instructions (OHI).
Receives: Procedure: Subgingival Instrumentation; Other: Oral Hygiene Instructions
Comparator GroupActive comparatorControl group participants will receive basic oral hygiene instructions
Receives: Other: Oral Hygiene Instructions

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Estimated glomerular filtration rate

    Renal function will be assessed by calculating the Estimated glomerular filtration rate (eGFR) using Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation. The CKD-EPI equation incorporates serum creatinine concentration, age, and sex to provide an estimate of kidney function expressed as mL/min/1.73 m².

    Measured: Estimated glomerular filtration rate (eGFR) estimation will be performed at 3,6,9 and 12 months.

  2. Soluble Urokinase Plasminogen Activator Receptor(suPAR)

    The estimation of soluble urokinase plasminogen activator receptor (suPAR) in plasma will be performed using a sandwich Enzyme-Linked Immunosorbent Assay (ELISA). The assay employs a sandwich ELISA technique, where suPAR in the plasma sample binds to specific antibodies immobilized on the microplate. Following incubation and washing steps, an enzyme-conjugated detection antibody and substrate solution will be added. The enzymatic reaction will produce a measurable colour change proportional to the concentration of suPAR. The absorbance will be recorded at 450 nm using an ELISA microplate reader, and the concentration was calculated using a standard curve.

    Measured: The estimation of soluble urokinase plasminogen activator receptor (suPAR) will be done at baseline and 12 months.

  3. Periodontal markers

    Different periodontal markers including Pocket Probing Depth(PPD), Clinical Attachment Loss(CAL), Bleeding on Probing(BOP), Calculus Component of Oral Hygiene Index will be estimated.

    Measurement will be done at six sites (mesiobuccal, mid-buccal, distobuccal, mesiolingual/palatal, mid-lingual/palatal, and distolingual/palatal) on all maxillary and mandibular teeth.

    PPD will be measured from the gingival margin to the base of the pocket, while CAL will be measured from the CEJ to the base of the pocket/sulcus. All the measurements will be rounded to the nearest millimeter and will be recorded using a Williams probe.

    For BOP, WHO Probe will be used and bleeding areas will be documented at six sites per tooth.

    Measured: Measurement will be done at Baseline, 3, 6, 9 and 12 months.

  4. Renal parameters including Serum creatinine, Serum albumin and Serum urea

    Renal parameters including Serum creatinine, Serum albumin and Serum urea will be assessed.

    Serum creatinine levels will be estimated using the Jaffe's kinetic method / enzymatic colorimetric method on an automated biochemistry analyser. The results will be expressed in milligrams per decilitre (mg/dL).

    Serum albumin levels will be measured using the bromocresol green (BCG) dye-binding method. The results will be expressed in grams per decilitre (g/dL). The normal reference range for serum albumin will be considered as 3.5-5.0 g/dL.

    Serum urea will be estimated using the urease-glutamate dehydrogenase (GLDH) method / diacetyl monoxime method on an automated analyser. The values will be expressed in mg/dL, with a normal reference range of 15-45 mg/dL.

    Measured: Renal parameters including Serum creatinine, Serum albumin and Serum urea will be assessed at baseline,3,6,9 and 12 months.

  5. Percentage of Chronic Kidney Disease patients progressing from pre-dialysis to dialysis.

    Percentage of Chronic Kidney Disease patients progressing from pre-dialysis status to dialysis will be calculated.

    Measured: Percentage of Chronic Kidney Disease patients progressing from pre-dialysis status to dialysis will be estimated from baseline till 12 month follow up.

Secondary outcomes (2)
  1. High-sensitivity C-reactive protein (hs-CRP)

    The concentration of high-sensitivity C-reactive protein (hs-CRP) in plasma will be estimated using a high-sensitivity immunoturbidimetric assay with a commercially available diagnostic kit. Plasma sample will be added to hs-CRP reagent containing anti-CRP antibodies. The mixture will be incubated to allow antigen-antibody complex formation. The change in absorbance will be measured using an automated biochemical analyzer. hs-CRP concentration will be determined using a calibration curve.

    Measured: Change in High-sensitivity C-reactive protein (hs-CRP) levels from baseline to 3,6,9 and 12 months will be checked.

  2. Glycated Haemoglobin (HbA1c) levels

    Glycated haemoglobin (HbA1c) levels will be measured to assess long-term glycaemic control among study participants. Venous blood samples will be collected and analyzed using standardized laboratory methods. HbA1c reflects the average blood glucose concentration over the preceding 2-3 months and will be expressed as a percentage (%). The measured HbA1c values will be used to evaluate participants' glycaemic status. Assessment will be performed at baseline, 3, 6, 9 and 12 months.

    Measured: Glycated haemoglobin (HbA1c) levels assessment will be done at baseline, 3, 6, 9 and 12 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jun 2026
  2. Study startJul 2026 (estimated)
  3. Primary completionJul 2027 (estimated)
  4. Study completionDec 2027 (estimated)

Resources

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
Prevention
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07635797
Sponsor's protocol ID
Gurleen2676
Status last verified
Jun 2026
First submitted
3 Jun 2026
Last updated
18 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Subgingival Instrumentation and Oral Hygiene Instructions in people with Chronic Kidney Disease and Periodontitis, run by Postgraduate Institute of Dental Sciences Rohtak at 1 site in India.

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 7 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: opening soon, as of the sponsor's last update on 18 Jun 2026. 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 India. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Gurleen Kaur, MDS (+91 9354031553, drgurleenphd@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Estimated glomerular filtration rate (time frame: Estimated glomerular filtration rate (eGFR) estimation will be performed at 3,6,9 and 12 months.). The study lists 5 primary outcomes in all. 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 18 Jun 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in