Islet Autoantibodies in generalized periodontitis and diabetes.

Not Applicable

Completed

• Conditions: Health Condition 1: E119- Type 2 diabetes mellitus without complications

• Registration Number: CTRI/2023/04/051353
• Lead Sponsor: Dr Irene Ann Thomas

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2023-12-08
• Last Update Posted: 4 March 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 80

Inclusion Criteria

1. Patients who have not received any periodontal treatment in previous six months.

2. Patients diagnosed with T2DM as per American Diabetes Association criteria (2019).

3. Patients with a diagnosis of Generalized Periodontitis as per World Workshop Classification criteria (2017).

Exclusion Criteria

1. Smokers and alcoholics.

2. Patients with systemic diseases like hypertension, cardiovascular diseases, rheumatoid arthritis, tumours, autoimmune diseases and renal diseases.

3. Pregnant, lactating females and post menopausal women.

4. Any other systemic disease which can alter the course of periodontal disease.

5. Patients on any medication like anti-inflammatory drugs, antibiotics and anti-epileptic drugs in the past 6 months.

6. Vitamin D deficiency.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.To estimate salivary and serum levels of Human Islet Antigen Insulinoma-Associated-2 Autoantibody and Zinc Transporter 8 Autoantibody in periodontally healthy, generalized periodontitis patients with / without T2DM and T2DM patients. <br/ ><br>2.To explore the association between Human Islet Antigen Insulinoma-Associated-2 Autoantibody and Zinc Transporter 8 Autoantibody in both periodontitis and T2DM. <br/ ><br>3.To compare between the salivary and serum levels of Human Islet Antigen Insulinoma-Associated-2 Autoantibody and Zinc Transporter 8 Autoantibody in periodontitis and T2DM patients and to correlate their levels with clinical parameters. <br/ ><br>4.To explore the possibility of assessing Human Islet Antigen Insulinoma-Associated-2 Autoantibody and Zinc Transporter 8 Autoantibody as inflammatory markers for both periodontal disease and T2DM.Timepoint: Baseline

Secondary Outcome Measures

Name	Time	Method
ot applicableTimepoint: Not applicable