Effectiveness of Subgingival Instrumentation on Delaying End-stage Renal Disease Among Chronic Ki… (NCT07635797) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Effectiveness of Subgingival Instrumentation on Delaying End-stage Renal Disease Among Chronic Kidney Disease Patients
India40 participantsStarted 2026-07
Plain-language 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.
Who can participate
Age range
40 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
* 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.
Exclusion Criteria:
* 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.
* Immunocompromised patients.
* Any history of tobacco use.
* Pregnant or lactating women.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is studying whether a dental cleaning procedure called subgingival instrumentation — where plaque and tartar are removed from below the gumline — could help slow the progression of my chronic kidney disease, so could you explain whether my current kidney function level and gum disease status would even make this kind of intervention relevant for my care?
2The trial is measuring things like my eGFR, serum creatinine, and a blood marker called suPAR to track kidney function over time — are these numbers already being monitored in my case, and what do my current results suggest about how fast my kidney disease might be progressing?
3Since this trial hasn't started recruiting yet, it could be a while before I could even consider joining — given where I am in my CKD journey right now, would waiting to potentially enroll in this study put me at risk of missing a window for other treatments that might help sooner?
4One of the things this trial is tracking is whether patients move from pre-dialysis to needing dialysis — based on my current condition, how concerned should I be about that transition, and does treating my gum disease seem like a realistic way to help delay it according to what's already known in the medical literature?
5This trial is listed as Phase NA, which often means it's evaluating a procedure rather than a new drug, so what does my doctor think about the existing evidence connecting periodontal treatment to kidney health, and is there any reason to consider getting my gum disease treated now regardless of whether I join this study?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Estimated glomerular filtration rate
Timeframe: Estimated glomerular filtration rate (eGFR) estimation will be performed at 3,6,9 and 12 months.
Timeframe: The estimation of soluble urokinase plasminogen activator receptor (suPAR) will be done at baseline and 12 months.
3
Periodontal markers
Timeframe: Measurement will be done at Baseline, 3, 6, 9 and 12 months.
4
Renal parameters including Serum creatinine, Serum albumin and Serum urea
Timeframe: Renal parameters including Serum creatinine, Serum albumin and Serum urea will be assessed at baseline,3,6,9 and 12 months.
5
Percentage of Chronic Kidney Disease patients progressing from pre-dialysis to dialysis.
Timeframe: Percentage of Chronic Kidney Disease patients progressing from pre-dialysis status to dialysis will be estimated from baseline till 12 month follow up.
Trial details
NCT IDNCT07635797
SponsorPostgraduate Institute of Dental Sciences Rohtak