“EFFECTS OF PERIODONTAL THERAPY IN PATIENTS WITH TYPE II DIABETETS MELLITUS AND CHRONIC PERIODONTITISâ€

Not yet recruiting

• Conditions: Patients with type II diabetes mellitus and chronic periodontitis

• Registration Number: CTRI/2013/10/004051
• Lead Sponsor: Dr Jerry Mammen

Brief Summary

Periodontal disease comprise of a group of inflammatory diseases of the supporting tissues of the teeth. It results from the complex inter play between specific microorganisms, their byproducts and host tissue response. Recent evidence suggest that periodontal infection may  significantly enhance the risk of various systemic diseases like coronary heart disease, diabetes mellitus, respiratory disease like COPD etc.

Diabetes mellitus (DM) is a metabolic disease characterized by hyperglycemia resulting from defects in insulin secretion, insulin action etc. (American Diabetes Association 2007). It is manifested as type I (IDDM), type II (NIDDM) and hyperglycemia secondary to other diseases or condition. Type II diabetes is the most common form of diabetes mellitus, accounting for 90% to 95% of all cases, and usually has an adult onset.DM is a known risk factor for periodontal disease but, vice versa periodontal disease may complicate the severity of diabetes by worsening glycemic control. Periodontitis is considered as the sixth complication of DM(WHO) and there is a bidirectional relationship betweenT2DM and periodontitis.

Acute bacterial and viral infections have been shown to increase insulin resistance and aggravate glycemic control. Systemic infections increase tissue resistance to insulin, preventing glucose from entering the target cells, causing elevated blood glucose levels and requiring increased pancreatic insulin secretion to maintain normoglycemia. Periodontal diseases involve inflammatory process and interaction of selected gram negative bacterial species with host response. Progression of disease further provides a portal of entry of microorganism and their byproducts into systemic circulation. The host responds to this challenge with an abnormally high inflammatory cellular response and many pro inflammatory cytokines (IL-1, IL-6 and TNF-α), which mediates activation of acute phase reactants like CRP, ceruloplasmin, alpha acid glycoprotein, serum amyloid.This chronic and sub clinical inflammation contributes to insulin resistance.

Insulin resistance contributes to the pathophysiology of diabetes and is a hallmark of obesity, metabolic syndrome, and many cardiovascular diseases. Therefore, quantifying insulin sensitivity/resistance is of great importance in clinical practice. Direct and indirect methods by using levels of fasting insulin level are currently employed for quantifying insulin sensitivity/resistance. A promising and reliable method for measuring insulin resistance is HOMA index using c peptide levels instead of fasting insulin level.

C-peptide is a small peptide, the pancreas releases C-peptide into the blood stream in equal amounts to insulin; it is produced as a large molecule known as proinsulin. By measuring the level of C-peptide in a person’s blood, we can determine the amount of insulin produced. C-peptide is preferred over insulin because it has a longer half-life and it does not have cross reactivity like insulin.

Evidence suggests that periodontal therapy can decrease the bacterial load, periodontal inflammation, and inflammatory cytokines, and thereby improving the glycaemic control. Very little is known about the effects of non-surgical periodontal therapy(NSPT) in modifying the insulin resistance and thereby improving insulin sensitivity.

**So we hypothesized that NSPT in patients with type 2 diabetes mellitus and chronic periodontitis could have an effect on insulin resistance.**

**Review of Literature**:

**1. Lamster IB et al** studied the relationship between oral health and diabetes mellitus. The authors reviewed the literature to identify oral conditions that are affected by diabetes mellitus. They also examined the literature concerning periodontitis as a modifier of glycemic control. The data support the fact that periodontitis is a complication of diabetes and periodontitis is a risk factor for poor glycemic control and the development of other clinical complications of diabetes. Concluded that periodontal changes are the first clinical manifestation of diabetes.

**2. P.M. Preshaw et al** reviewed a two way relationship between periodontitis and diabetes, with diabetes increasing the risk for periodontitis, and periodontal inflammation negatively affecting glycaemia control. Epidemiological studies confirm that diabetes is a significant risk factor for periodontitis, and the risk of periodontitis is greater if glycaemia control is poor**3. Wei-Lian Sun ,et al** studied levels of Inflammatory Cytokines, Adiponectin,Insulin Resistance and Metabolic Control after Periodontal Intervention in Patients with Type 2 Diabetes and Chronic Periodontitis. A total of 190 patients of moderately poor type II diabetes patients were taken and divided into treatment group and non-treatment group and the levels of inflammatory cytokines, insulin resistance and metabolic control were measured after complete periodontal intervention. The levels of clinical periodontal variables were improved significantly in T2DM-T group after 3 months compared to T2DM-NT group and also the serum levels of hsCRP, TNF-α, IL-6, fasting plasma glucose (FPG), glycosylated haemoglobin (HbA1c), fasting insulin (FINS) and HOMA-IR index decreased, and adiponectin was significantly increased.

 **Aim**

To assess the effect of NSPT in patients with type II diabetes mellitus with chronic periodontitis in improving the insulin sensitivity.

**Objectives**

1.     To find out level of c-peptide before and after NSPT in patients with type II diabetes mellitus and chronic periodontitis.

2.     To assess levels of  insulin resistance/sensitivity using HOMA INDEX

3.     To assess the effect of NSPT on glycemic control

4.     To assess the effect of NSPT on CRP level.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-02-12
• Last Update Posted: 2013-07-10

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Patients with age group between 30 to 50.
• Minimum of 20 teeth present.
• Patients who were diagnosed with severe periodontitis chronic periodontitis (CDC criteria moderate periodontitis is defind as ≥2 interproximal sites with ≥ 4mm clinical attacment loss (CAL) not on same tooth,or ≥2 interproximal with probing depth (PD) ≥ 5mm not on same tooth severe periodontitis is defind as ≥2 teeth with clinical attachment loss ≥6mm not on same tooth and ≥1 interproximal site with probing depth ≥ 5mm).
• Patients diagnosed with type II diabetes mellitus(moderately poor glycemic control, HbA1c between7% and 10%), on oral hypoglycemic drugs and dietary modification only.

Exclusion Criteria

• 1.Patients with known systemic disease and condition, other than type II diabetes mellitus such as CVD, renal disease, RA, , liver and pancreatic disease, nutritional deficiencies, pregnant and lactating mother.
• Patients with acute condition that contraindicate a periodontal examination.
• Patients who received systemic antibiotic therapy within past 6 month.
• Patients who received periodontal therapy (scaling and root planing or surgery) past 1 year.
• Smokers and smokeless tobacco users 6.
• Patients not willing to sign informed consent.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
insulin resistance	three months

Secondary Outcome Measures

Name	Time	Method
Glycemic control

Trial Locations

Locations (1)

Government Dental college; 🇮🇳 Kozhikode, KERALA, India

Government Dental college

🇮🇳Kozhikode, KERALA, India

Dr jerry mammen

Principal investigator

09567075899

jerrymammen@hotmail.com