Periodontal Treatment and Glycemic Control

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the effects of non surgical periodontal treatment on glycemic control in type II diabetics.

Detailed Description
-----------------
The selected patients in treatment group will be given mechanical periodontal treatment in the form of scaling and root planning while the non intervention group patients will not receive treatment until the end of the trial.

Official Title
-----------------
Impact of Non Surgical Periodontal Treatment on Glycemic Control in Type II Diabetics

Conditions
-----------------
Diabetes Mellitus Type 2

Intervention / Treatment
-----------------
* Procedure: Non Surgical Periodontal Treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed patients of Type 2 Diabetes Mellitus for at least 2 years HbA1C values >6.5 % as per ADA criteria non smokers Patients with at least 16 standing teeth At least 8 teeth with one site having Mild to Moderate periodontal disease Exclusion Criteria: Smokers Type 2 Diabetics with complications e.g. renal, ophthalmic etc Patients with chronic infections Patients who get hospitalized or have to change their medications during the course of study

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Periodontal Treatment<br>Periodontal Treatment in the form of Full mouth scaling and root planning will be given at one time only i.e. at baseline after full mouth dental checkup. Checkup will be repeated at 3, 6 & 9 month interval along with HbA1C levels | Procedure: Non Surgical Periodontal Treatment<br>* one time intervention in the form of scaling and root planing<br>|
| No Intervention: Non treatment group<br>this group will only receive detailed dental check ups at the specified time 0, 3, 6 and 9 months respectively and there will be no scaling done. HbA1C levels will be estimated at the above specified times | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in HbA1C levels from base line at 3, 6 and 9 months | HbA1C levels will be recorded and any change in percentage noted | 3 months, 6 months, 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bleeding on Probing | a change in the above mentioned periodontal parameters will be recorded at the specified times Bleeding on probing will be recorded as Yes or No for each tooth | Base Line, 3 months, 6 months and 9 months | 
| Clinical Attachment Loss | A change in the above mentioned periodontal parameter will be recorded at the specified times Clinical Attachment loss will be recorded in millimeters for each tooth | Base Line, 3 months, 6 months, 9 months | 
| Periodontal Pocket Depth | A change in Periodontal pocket will be measured in millimeters for the above mentioned time frame | Base Line, 3 months, 6 months, 9 months |