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NCT07635797
Effectiveness of Subgingival Instrumentation on Delaying End-stage Renal Diseases Among Chronic Kidney Disease Patients
Conditions: Chronic Kidney Disease, Periodontitis, End Stage Renal Disease (ESRD)
Sex: All
Ages: 40 Years – 70 Years
Healthy volunteers: No
Phase: NA
Enrollment: 40
Sponsor: Postgraduate Institute of Dental Sciences Rohtak
Location: Post Graduate Institute of Dental Sciences , Rohtak Rohtak Haryana
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.
Eligibility Criteria
Inclusion Criteria:
* 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 \8 %.
* Any Periodontal therapy within past 6 months.
* Immunocompromised patients.
* Any history of tobacco use.
* Pregnant or lactating women.
Source: ClinicalTrials.gov (NCT07635797). StuddyBuddy aggregates publicly available trial information.