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CTRI Number  CTRI/2013/05/003660 [Registered on: 21/05/2013] Trial Registered Retrospectively
Last Modified On: 25/09/2013
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Preventive
Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   non-surgical periodontal therapy in type II diabetic patients 
Scientific Title of Study   Effect of non-surgical periodontal therapy on glycaemic control in type II diabetic patients: A randomized controlled 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  DrRavishankar TL 
Designation  Associate Professor 
Affiliation  kothiwal dental college and research centre 
Address  kothiwal dental college and research centre, kanth road, moradabad
kothiwal dental college and research centre, kanth road, moradabad
Moradabad
UTTAR PRADESH
244001
India 
Phone  9219612715  
Fax    
Email  telgiravi@yahoo.com  
 
Details of Contact Person
Scientific Query
 
Name  DrRavishankar TL 
Designation  Associate Professor 
Affiliation  kothiwal dental college and research centre 
Address  kothiwal dental college and research centre, kanth road, moradabad
kothiwal dental college and research centre, kanth road, moradabad
Moradabad
UTTAR PRADESH
244001
India 
Phone  9219612715  
Fax    
Email  telgiravi@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  DrRavishankar TL 
Designation  Associate Professor 
Affiliation  kothiwal dental college and research centre 
Address  kothiwal dental college and research centre, kanth road, moradabad
kothiwal dental college and research centre, kanth road, moradabad
Moradabad
UTTAR PRADESH
244001
India 
Phone  9219612715  
Fax    
Email  telgiravi@yahoo.com  
 
Source of Monetary or Material Support  
self 
 
Primary Sponsor  
Name  vaibhav tandon 
Address  kothiwal dental college, kanth road , moradabad. 
Type of Sponsor  Other [self] 
 
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 
Vaibhav Tandon  Diabetic Centre  Lajpatnagar Moradabad
Moradabad
UTTAR PRADESH 
9319082837

vaibhavtandon35@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
ethical committe on human/animal subjects research / Moradabad/ Dr.Chaubey  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  diabetic and mild periodontitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Non-Surgical periodontal therapy, mouthwash, brushing  Non-surgical Periodontal therapy leads to removal of necrotic tissue,which leads in reduction of gingival inflammation which in turn causes reduction in inflammatory cytokinines nd other chemical mediators of inflammation 
Comparator Agent  Only brushing  Regular brushing removes the plaque by mechanical debridement, which causes removal of the bacteria present in plaque and calculus and leads to reduction in gingival inflammation.  
 
Inclusion Criteria  
Age From  35.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  Blood sugar controlled only with oral hypoglycaemic agents and no systemic antibiotic administration or periodontal treatment within the last six months.  
 
ExclusionCriteria 
Details  Patients with systemic diseases other than Diabetes Mellitus type II, tobacco and alcohol users and patients who were suffering from oral disease that need emergency treatment like endo-perio lesion, periodontal abscess. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Glycated Haemoglobin(HbA1c)in%  data will be recorded at baseline and after 3 months 
 
Secondary Outcome  
Outcome  TimePoints 
Probing Pocket Depth(PPD)in mm,
Plaque Index (PI) ,
Gingival Index(GI) 
data will be recorded at baseline and after 3 month of intervention  
 
Target Sample Size   Total Sample Size="100000"
Sample Size from India="100000" 
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   Phase 3 
Date of First Enrollment (India)   25/03/2013 
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="3"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

INTRODUCTION

Diabetes mellitus (DM) is a chronic, non-communicable disease and also one of the major global public health issues. It is defined as a clinical syndrome characterized by hyperglycemia due to the defect in insulin secretion by pancreatic β cells, decrease in insulin sensitivity, or a combination of both. The most common form of DM is Diabetes mellitus type 2 (DM2), which accounts for 85% of all diabetes patients.1 Periodontal disease is the most prevalent oral complication in patients with type 2 diabetes mellitus. Periodontitis is a disease characterized by periodontal pocket formation, loss of connective tissue attachment, alveolar bone resorption, and gingival inflammation, ultimately resulting in tooth loss.

The observation that periodontal therapy appears to reduce periodontal infection and inflammation, suggests that periodontal therapy may facilitate metabolic control of diabetes, improving insulin sensitivity by reducing peripheral inflammatory cytokines levels.2 Therefore, we put on the hypothesis that if periodontitis is casually related to worsening of parameters of diabetic patients, then periodontal treatment should improve glycaemic control.

The aim of the study is to investigate the effects of non- surgical periodontal therapy on glycaemic control in DM2 patients.

METHODOLOGY

Convenient sample of 60 patients aged 35-45 years will be selected from a Diabetic Centre in Moradabad. Patient who came to Diabetic Centre for their routine check up and investigation will screen for type II Diabetes Mellitus and Periodontitis.

 This study was revived and approved by the institutional Ethical Review Committee, Moradabad.

The inclusion criteria include; Blood sugar controlled only with oral hypoglycaemic agents and no systemic antibiotic administration or periodontal treatment within the last six months. The exclusion criteria includes; Patients  with systemic diseases other than Diabetes Mellitus type II, tobacco and alcohol users and  patients who were suffering from oral disease that need emergency treatment like endo-perio lesion, periodontal abscess.

The oral examination will be conducted in dental clinical wing of the diabetic centre. Oral examination includes assessing periodontal Pocket Depth, Gingival status and Plaque accumulation of each individual patient. Periodontal pocket depth was assessed by measuring Probing pocket depth(PPD) with UNC-15 probe at six points for each tooth and the arithmetic mean value of all the teeth was considered. Gingival status was assessed by Gingival Index, Loe & Silness (1963). Dental plaque was assessed by Plaque Index, Silness & Loe(1967).

Glycemic status will be assesses by the HbA1c and fasting blood sugar level. Participating subjects were interviewed for the demographic data, duration and the frequency of a drug and were cross verified with the hospital records.

 
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