COMPARATIVE EVALUATION OF BIOMARKER LEVELS IN PERIODONTITIS PATIENTS WITH TYPE2 DIABETES MELIITUS

Not Applicable

Completed

• Conditions: Health Condition 1: E116- Type 2 diabetes mellitus with other specified complications

• Registration Number: CTRI/2019/06/019508
• Lead Sponsor: Gayathri K

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2019-09-30
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 75

Inclusion Criteria

1.Minimum number of 15 teeth should be present.

2.Patients with Generalised Chronic periodontitis exhibiting Probing Pocket depth of more than or equal to 4mm with Clinical attachment level of more than or equal to 3mm in more than 30percent of diseased sites, According to the AAP 1999 World Workshop (Group I)

3.If more than five sites satisfy the criteria, sample sites were selected based on greater amount of gingival inflammation, probing pocket depth and clinical attachment level.

4.Chronic periodontitis patient with Type 2 diabetes mellitus exhibiting good and poor control.

According to American Diabetic Association(ADA) classification of glycaemic control-

a) Subjects with HbA1c below 7% , as Type 2 diabetics with good control in one group(group II)

b) Subjects with HbA1c more than 8% , as Type 2 diabetics with poor control in another group(group III)

Exclusion Criteria

1.Patients with other systemic condition or diseases influencing the course of periodontal disease other than diabetes.

2.Patients with haemoglobinopathies, bleeding and clotting disorders that will influence HbA1c level.

3.History of periodontal treatment within the previous six months

4.Antimicrobial therapy immunosuppressants or lipid lowering drugs within the past 3months

5.Current Smokers who have smoked more than or equal to 100 cigarettes in their lifetime and currently smoke,Former smokers have smoked more than or equal to 100 cigarettes

6.Heavy alcoholics

7.Pregnancy and Lactation

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.To evaluate the levels of Endocan and TNF-alpha in gingival crevicular fluid in systemically healthy Chronic Periodontitis subjects <br/ ><br>2.To evaluate the levels of Endocan and TNF-alpha in gingival crevicular fluid in chronic periodontitis subjects with well controlled diabetes mellitus (HbA1C less than 7). <br/ ><br>3.To evaluate the levels of Endocan and TNF-alpha in gingival crevicular fluid in chronic periodontitis subjects with poorly controlled diabetes mellitus (HbA1C more than 8). <br/ ><br> <br/ ><br>Timepoint: At baseline and after 3months

Secondary Outcome Measures

Name	Time	Method
1.To compare the levels of Endocan and TNF-alpha between study groups. <br/ ><br>2.To Correlate Endocan and TNF-alpha levels with the periodontal clinical parameters in all the groups before and after non-surgical periodontal therapy <br/ ><br>Timepoint: At baseline and at 3months