Health Condition 1: N184- Chronic kidney disease, stage 4 (severe)
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Patients aged 40 to 70 years. Type 2 diabetes mellitus with chronic kidney disease and currently on oral hypoglycaemic agents. Diagnosed with Stage IV chronic kidney disease with eGFR between 15 and 20 mL per min per 1.73 m2. Not undergoing dialysis. Presence of at least 20 natural teeth. Diagnosed with Stage II periodontitis according to the 2017 World Workshop Classification with interdental clinical attachment loss at the site of greatest loss greater than 2 mm but less than 5 mm in at least 2 non-adjacent teeth. Willing to provide written informed consent.
Exclusion criteria
Exclusion criteria: Patients already undergoing haemodialysis or renal transplantation. Patients on insulin therapy or taking SGLT2 inhibitors and GLP 1 receptor agonists. Glycated haemoglobin HbA1c level greater than 8 percent. Any periodontal therapy within the past 6 months. Immunocompromised patients. Any history of tobacco use. Pregnant or lactating women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Estimated Glomerular Filtration Rate eGFRTimepoint: Baseline,3,6,9,12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in suPAR Soluble urokinase plasminogen Activator ReceptorTimepoint: Baseline and 12 months;Change in periodontal markers including Pocket Probing Depth PPD, Clinical Attachment Loss CAL, Bleeding on Probing BOP, Calculus Component of Oral Hygiene IndexTimepoint: Baseline,3,6,9,12 months;Change in Renal parameters including Serum creatinine, Serum albumin and Serum ureaTimepoint: Baseline,3,6,9,12 months;Percentage of Chronic Kidney Disease patients progressing from pre-dialysis to dialysis.Timepoint: Baseline to 12 months;Association of serum biochemical markers with periodontal markers and renal parametersTimepoint: Baseline,3,6,9,12 months;Change in the concentration of high-sensitivity C-reactive protein hs-CRP in plasmaTimepoint: Baseline,3,6,9,12 months;Change in HbA1c levelsTimepoint: Baseline,3,6,9,12 months | — |
Countries
India
Contacts
Pandit Bhagwat Dayal Sharma Post Graduate Institute of Dental Sciences Rohtak