Brief Summary (Lay Description)
This research study is being conducted to understand whether treating gum disease (periodontitis) can help improve kidney health in patients who have type-2 diabetes mellitus (T2DM). Both diabetes and gum disease are common long-term conditions that often occur together. People with uncontrolled diabetes are at risk of developing kidney problems due to damage in the small blood vessels of the kidneys - a condition known as diabetic nephropathy.
Scientific evidence has already shown that treating gum disease can help improve blood sugar control in diabetic patients. However, it is still unclear whether gum treatment can also help reduce the risk or severity of kidney-related complications. This study aims to find out if non-surgical periodontal therapy (NSPT), which includes scaling and root planing (deep dental cleaning), has any effect on blood markers of kidney function - specifically urea, creatinine, and estimated glomerular filtration rate (eGFR) - in patients with uncontrolled type-2 diabetes.
The study will be conducted as a randomized controlled trial involving 46 patients with uncontrolled T2DM (HbA1c ≥ 7%) who also have moderate to severe gum disease. Participants will be divided randomly into two groups:
Test Group: Will receive full-mouth non-surgical periodontal therapy (scaling and root planing) and oral hygiene instructions.
Control Group: Will receive oral hygiene instructions only and will get the same gum treatment later (after 90 days, as delayed therapy).
All participants will have their gum health examined, and blood tests will be done at the start and again after 90 days to measure urea, creatinine, and eGFR levels. These tests help determine how well the kidneys are working. The changes in these values before and after gum treatment will show whether improving oral health has any beneficial impact on kidney function in diabetics.
The study is expected to take one year and will be conducted at Dow University of Health Sciences, Karachi. All participants will receive standard dental and laboratory assessments at no cost. The results may help improve future strategies for managing diabetic patients by integrating oral health care with medical care.
Purpose:
To determine whether treating gum disease (through non-surgical periodontal therapy) can improve kidney function markers - urea, creatinine, and eGFR - in patients with uncontrolled type-2 diabetes mellitus.
Question being answered:
Does non-surgical periodontal therapy have a positive effect on kidney function in uncontrolled type-2 diabetic patients by reducing urea and creatinine levels and improving eGFR?
None
None
Parallel
scaling and root planning
Procedure/SurgeryIntervention 1: Scaling and Root Planing (SRP) + Oral Hygiene Instructions (OHI) Intervention Description: Participants assigned to the intervention arm will receive full-mouth non-surgical periodontal therapy consisting of scaling and root planning (SRP). Ultrasonic scalers will be used to remove supragingival plaque and calculus, followed by hand instruments (curettes and scalers) for subgingival debridement and root planing. The procedure is performed in a single session by trained and calibrated dental hygienists. Participants will also receive standardized oral hygiene instructions (OHI), including demonstration of the Modified Stillman's toothbrushing technique using a soft-bristle toothbrush and fluoridated toothpaste twice daily. Each participant will be provided with an oral hygiene kit to ensure consistency. Postoperative care includes warm saline rinses for three days. No further periodontal treatment will be given during the 90-day follow-up period.
Change from Baseline in Serum Creatinine, Blood Urea Nitrogen, and Estimated Glomerular Filtration Rate (eGFR) at 90 Days After Non-Surgical Periodontal Therapy
The primary outcome will be evaluated by measuring changes in renal function biomarkers, including serum creatinine (mg/dL), blood urea nitrogen (BUN, mg/dL), and estimated glomerular filtration rate (eGFR, mL/min/1.73 m²). These parameters will be assessed at baseline and 90 days post-intervention to determine within- and between-group differences. Serum creatinine and BUN will be analyzed using standard automated laboratory methods, and eGFR will be calculated using the Modification of Diet in Renal Disease (MDRD) equation. A reduction in serum creatinine and BUN levels and an increase in eGFR will indicate improvement in renal function. Data will be statistically analyzed using Wilcoxon signed-rank and Mann-Whitney U tests with a significance threshold of p ≤ 0.05
Click on the lead sponsor to view all of their trials.
