FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2013/10/004051 [Registered on: 08/10/2013] Trial Registered Prospectively
Last Modified On: 07/10/2013
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   “EFFECTS OF PERIODONTAL THERAPY IN PATIENTS WITH TYPE II DIABETETS MELLITUS AND CHRONIC PERIODONTITIS”  
Scientific Title of Study   “EFFECTS OF NON SURGICAL PERIODONTAL THERAPY ON INSULIN RESISTANCE IN PATIENTS WITH TYPE II DIABETETS MELLITUS AND CHRONIC PERIODONTITIS”- A CLINICAL TRIAL 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr jerry mammen 
Designation  junior resident 
Affiliation  Government dental college, Kozhikode 
Address  Dept of periodontics, Government dental college, kozhikode

Kozhikode
KERALA
673008
India 
Phone  09567075899  
Fax    
Email  jerrymammen@hotmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Rosamma Joseph V 
Designation  Professor and HOD 
Affiliation  Government dental college, Kozhikode 
Address  Dept of periodontics, Government dental college, kozhikode

Kozhikode
KERALA
673008
India 
Phone  09446070599  
Fax    
Email  drrosammajoseph@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Rosamma Joseph V 
Designation  Professor and HOD 
Affiliation  Government dental college, Kozhikode 
Address  Dept of periodontics, Government dental college, kozhikode

Kozhikode
KERALA
673008
India 
Phone  09446070599  
Fax    
Email  drrosammajoseph@gmail.com  
 
Source of Monetary or Material Support  
Government Dental college, Kozhikode 
 
Primary Sponsor  
Name  Dr Jerry Mammen 
Address  Dept of periodontics, Government dental college, Kozhikode 
Type of Sponsor  Other [Personal money] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr jerry mammen  Government Dental college  Department of periodontics, Room no :38, Third floor, Government dental college
Kozhikode
KERALA 
09567075899

jerrymammen@hotmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee, Government dental college, Kozhikode  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Patients with type II diabetes mellitus and chronic periodontitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  no treatment  In patients with type II diabetes mellitus and chronic periodontitis, no periodontal therapy is given for 3 months 
Intervention  Non surgical periodontal therapy  Non surgical periodontal therapy includes ultrasonic scaling, sub gingival curettage and root planing over a period of two three appointments of an hour each 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  1. Patients with age group between 30 to 50.
2. Minimum of 20 teeth present.
3. 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).
4. Patients diagnosed with type II diabetes mellitus(moderately poor glycemic control, HbA1c between7% and 10%), on oral hypoglycemic drugs and dietary modification only
 
 
ExclusionCriteria 
Details  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.
2. Patients with acute condition that contraindicate a periodontal examination.
3. Patients who received systemic antibiotic therapy within past 6 month.
4. Patients who received periodontal therapy (scaling and root planing or surgery) past 1 year.
5. Smokers and smokeless tobacco users
6. Patients not willing to sign informed consent
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
insulin resistance  three months 
 
Secondary Outcome  
Outcome  TimePoints 
Glycemic control

 
three months 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   02/12/2013 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

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.

 
Close