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

NCT07256613 | Recruiting DMC

• 1 other identifier: 3642/DUHS/Approval/2024/311
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief 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?

Conditions

Type 2 Diabetes Mellitus MeSH:D003924; Periodontitis MeSH:D010518; Diabetic Nephropathies MeSH:D003928

Keywords

Type 2 Diabetes Mellitus; Uncontrolled Type 2 Diabetes; Diabetes-related nephropathy; Chronic kidney disease (CKD); Diabetic nephropathy; periodontitis; non surgical periodontal therapy; scaling; root palnning; serum creatinine; blood urea nitrogen; BUN; eGFR; MDRD GFR euation; oral hygiene instruction(OHI); Randomised control trial

Outcome Measures

Primary Outcomes (1)

• 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

  Baseline and 90 days after completion of non-surgical periodontal therapy

Study Arms (2)

Non-Surgical Periodontal Therapy (Scaling and Root Planing + Oral Hygiene Instructions)

EXPERIMENTAL

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)

Procedure: scaling and root planning

Control - Oral Hygiene Instructions with Delayed Periodontal Therapy

ACTIVE COMPARATOR

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

Procedure: scaling and root planning

Interventions

scaling and root planning PROCEDURE

Intervention 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.

Control - Oral Hygiene Instructions with Delayed Periodontal Therapy; Non-Surgical Periodontal Therapy (Scaling and Root Planing + Oral Hygiene Instructions)

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dow University of Health Sciences: lead

Study Sites (1)

Dow University of Health Scinces

Karachi, Sindh, 75330, Pakistan

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Renal Insufficiency, Chronic; Diabetic Nephropathies; Periodontitis

Interventions

Tooth Exfoliation

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Diabetes Complications; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Dental Physiological Phenomena; Digestive System and Oral Physiological Phenomena

Central Study Contacts

Muhammad Ather Khan, BDS

CONTACT

+92-333-2685579; ather.khan@duhs.edu.pk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Model Details: Parallel Assignment - Participants are randomly assigned to one of two groups: an intervention group receiving non-surgical periodontal therapy and a control group receiving delayed therapy after the study period.

Study Record Dates

• First Submitted: November 20, 2025
• First Posted: December 1, 2025
• Study Start: August 15, 2025
• Primary Completion: January 15, 2026
• Study Completion: April 15, 2026
• Last Updated: December 1, 2025

Record last verified: 2025-11

Locations

PA (1)