Actively Recruiting

Phase Not Applicable
Age: 30Years - 65Years
All Genders
NCT07256613

Non-surgical Periodontal Therapy and Kidney Outcomes in Type 2 Diabetes Mellitus

Led by Dow University of Health Sciences · Updated on 2025-12-01

46

Participants Needed

1

Research Sites

34 weeks

Total Duration

On this page

AI-Summary

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?

CONDITIONS

Official Title

Non-surgical Periodontal Therapy and Kidney Outcomes in Type 2 Diabetes Mellitus

Who Can Participate

Age: 30Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults between 30 and 65 years of age
  • Men and women diagnosed with type 2 diabetes mellitus for at least one year
  • Uncontrolled diabetes with HbA1c of 7% or higher
  • Moderate to severe gum disease (Stage II or Stage III periodontitis)
  • Estimated glomerular filtration rate (eGFR) of 60 mL/min/1.73 m² or higher
  • Able and willing to provide written informed consent
Not Eligible

You will not qualify if you...

  • Critically ill or unable to communicate effectively
  • Pregnant or breastfeeding women
  • Women using hormone replacement therapy or oral contraceptives in the past six months
  • Use of steroidal, nonsteroidal anti-inflammatory drugs (NSAIDs), or other anti-inflammatory meds in past three months (except low-dose aspirin up to 75 mg daily)
  • 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
  • Presence of other chronic diseases or conditions that could affect study results
  • Unwilling or unable to comply with study procedures or follow-up visits

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Trial Site Locations

Total: 1 location

1

Dow University of Health Scinces

Karachi, Sindh, Pakistan, 75330

Actively Recruiting

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Research Team

M

Muhammad Ather Khan, BDS

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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