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

Sponsor
Postgraduate Institute of Dental Sciences Rohtak
Study ID
NCT07635797
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
40 Years - 70 Years
Healthy Volunteers
Not accepted

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).
  • Oral Hygiene Instructions — OTHER
    Participants will receive basic oral hygiene instructions

Study Details

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.

Key Dates

First listed
Jun 9, 2026
Start date
Jul 31, 2026
Status verified
Jun 2026
Primary completion
Jul 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
40 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Intervention Group
    Intervention 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).
  • Active Comparator: Comparator Group
    Control group participants will receive basic oral hygiene instructions

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. ]

Central Contacts

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