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.
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.
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.
Parallel
Subgingival Instrumentation
Procedure/SurgeryParticipants 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 Instructions
Other interventionParticipants will receive basic oral hygiene instructions
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.
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.
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.
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.
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.
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.
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