Outcomes of Non-surgical Periodontal Therapy on Urea and Creatinine Levels in Type-2 Diabetes Mellitus Patients

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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?

Eligibility
Participation Requirements
Sex: All
Minimum Age: 30
Maximum Age: 65
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Pakistan
Dow University of Health Scinces
RECRUITING
Karachi
Contact Information
Primary
Muhammad Ather Khan, BDS
ather.khan@duhs.edu.pk
+92-333-2685579
Time Frame
Start Date: 2025-08-15
Estimated Completion Date: 2026-04-15
Participants
Target number of participants: 46
Treatments
Experimental: Non-Surgical Periodontal Therapy (Scaling and Root Planing + Oral Hygiene Instructions)
Participants in this arm will receive full-mouth non-surgical periodontal therapy, including ultrasonic scaling and manual root planing in a single session performed by trained dental hygienists. This treatment aims to remove supra- and subgingival plaque and calculus to reduce periodontal inflammation. Standardized oral hygiene instructions will also be provided, including demonstration of the Modified Stillman's brushing technique using a soft toothbrush and fluoridated toothpaste twice daily. Participants will be monitored for 90 days to assess changes in renal biomarkers (serum creatinine, blood urea nitrogen, and eGFR)
Active_comparator: Control - Oral Hygiene Instructions with Delayed Periodontal Therapy
Participants in the control arm will receive only standardized oral hygiene instructions at baseline and will not undergo scaling and root planing during the 90-day study period. After completion of follow-up assessments, they will receive the same periodontal therapy as the intervention group (delayed therapy) to ensure ethical equivalence
Sponsors
Leads: Dow University of Health Sciences

This content was sourced from clinicaltrials.gov