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

Condition(s) studied

Investigational drug(s) / intervention(s)

Subgingival Instrumentation: 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 Instructions: Participants will receive basic oral hygiene instructions

Study 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. 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.

Eligibility

Primary outcome measure(s)

• Estimated glomerular filtration rate — Estimated glomerular filtration rate (eGFR) estimation will be performed at 3,6,9 and 12 months.
  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) will be done at baseline and 12 months.
  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 — Measurement will be done at Baseline, 3, 6, 9 and 12 months.
  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 at baseline,3,6,9 and 12 months.
  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.
• 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 estimated from baseline till 12 month follow up.
  Percentage of Chronic Kidney Disease patients progressing from pre-dialysis status to dialysis will be calculated.

Trial sites (1)

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