Non-surgical Periodontal Therapy and Kidney Outcomes in Type 2 Diabetes Mellitus
Recruiting · NCT07256613 · Interventional (participants receive a specific treatment) · Lead sponsor: Dow University of Health Sciences
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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?
Who can take part
Inclusion criteria
- Adults between 30 and 65 years of age.
- Men and women previously diagnosed with type 2 diabetes mellitus for at least one year.
- Participants with uncontrolled diabetes, defined as HbA1c ≥ 7%.
- Presence of moderate to severe gum disease (Stage II or Stage III periodontitis) as determined by a dental examination.
- Estimated glomerular filtration rate (eGFR) of 60 mL/min/1.73 m² or higher.
- Willing and able to provide written informed consent.
Exclusion criteria
- Critically ill individuals or those unable to communicate effectively.
- Pregnant or breastfeeding women.
- Women currently using hormone replacement therapy or oral contraceptives within the past six months.
- Individuals taking steroidal, nonsteroidal anti-inflammatory drugs (NSAIDs), or other anti-inflammatory medications within the past three months (except low-dose aspirin up to 75 mg daily).
- Participants with a recent history of major blood loss, trauma, or gastrointestinal bleeding.
- Use of antibiotics within the last month.
- History of fever or vomiting lasting more than one week within the last month.
- Regular tobacco or alcohol users.
- Individuals with any other chronic disease or condition that could interfere with study outcomes.
- Individuals unwilling or unable to comply with study procedures or follow-up visits.
Where it is running
2 locations listed.
- Dow University of Health Scinces - Karachi, Sindh, Pakistan
- Dow University of Health Scinces - Karachi, Sindh, Pakistan