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

NCT07635797 | Not Yet Recruiting

• 1 other identifier: Gurleen2676
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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 Randomized controlled trial is undertaken to address this gap.

Conditions

Chronic Kidney Disease; Periodontitis; End Stage Renal Disease (ESRD)

Keywords

Chronic Kidney Disease; Subgingival Instrumentation; Periodontitis; End Stage Renal Disease; Dialysis

Outcome Measures

Primary Outcomes (5)

• 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.

  Estimated Glomerular filtration rate (eGFR) estimation will be performed at 3,6,9 and 12 months

• 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 produced a measurable color 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.

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

• 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 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 were recorded using a Williams probe. For BOP, WHO Probe will be used and bleeding areas are documented at six sites per tooth.

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

• 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 were expressed in grams per decilitre (g/dL). The normal reference range for serum albumin was taken 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.

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

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

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

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

Secondary Outcomes (2)

• High-sensitivity C-reactive protein (hs-CRP)

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

• Glycated Haemoglobin (HbA1c) levels

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

Study Arms (2)

Intervention Group

EXPERIMENTAL

IG 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).

Procedure: Subgingival Instrumentation; Other: Oral Hygiene Instructions

Comparator Group

ACTIVE COMPARATOR

control group participant will receive basic oral hygiene instructions

Other: Oral Hygiene Instructions

Interventions

Subgingival Instrumentation PROCEDURE

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).

Intervention Group

Oral Hygiene Instructions OTHER

Participants will receive basic oral hygiene instructions

Comparator Group; Intervention Group

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 40-70 years.
• Type 2 diabetes mellitus with chronic kidney diseases and currently on oral hypoglycemic 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.

You may not qualify if:

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

Sponsors & Collaborators

• Postgraduate Institute of Dental Sciences Rohtak: lead

Study Sites (1)

Post Graduate Institute of Dental Sciences , Rohtak

Rohtak, Haryana, 124001, India

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Periodontitis; Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Vipul Yadav, MDS

  Professor, Department of Public Health Dentistry, Post Graduate Institute of Dental Sciences Rohtak

  STUDY DIRECTOR

Central Study Contacts

Gurleen Kaur, MDS

CONTACT

+91 9354031553; drgurleenphd@gmail.com

Vipul Yadav, MDS

CONTACT

+91 8826363961; vipulyadavv.97@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2026
• First Posted: June 9, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: June 9, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)