The effect of treatment for gum disease (periodontitis) on the type and amount of lipids (fats) in the blood and the function of the endothelium, the thin membrane that lines the heart and blood vessels, in patients with type 2 diabetes

Not Applicable

Completed

• Conditions: Oral Health; Improvement of endothelial function and serum lipid profile in patients with type 2 diabetes via periodontal treatment

• Registration Number: ISRCTN69139365
• Lead Sponsor: Albanian University

Brief Summary

2022 Results article in https://pubmed.ncbi.nlm.nih.gov/36289786/ results (added 16/01/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2019-03-29
• Study Start: 2022-07-23
• Last Update Posted: 30 January 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 290

Inclusion Criteria

1. Patients diagnosed with type 2 diabetes
2. Generalized periodontitis

Exclusion Criteria

1. Provision of informed consent prior to initiation of any study procedures
2. Declined cognitive function and unable to make informed consent
3. Periodontal treatment within the last 12 months
4. Systemic antibiotic therapy within the last 6 months
5. Pregnancy or breastfeeding
6. Uncontrolled hypertension
7. History of heart disease or stroke which might interfere with systemic antioxidative status
8. Active smokers (>10 cigarettes/daily) were excluded

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> Serum lipid profile including levels of:<br> 1. Serum total cholesterol measured by enzyme-linked immunosorbent assays (ELISA) at baseline, 3, and 6 months<br> 2. Serum triglyceride measured by ELISA at baseline, 3, and 6 months<br> 3. Low-density lipoprotein cholesterol measured by ELISA at baseline, 3, and 6 months<br> 4. High-density lipoprotein cholesterol measured by ELISA at baseline, 3, and 6 months<br> 5. Flow-mediated vasodilation (FMD) was assessed non-invasively, using the flow-mediated dilation (FMD) technique at baseline, 3, and 6 months<br> - as an index of endothelium-dependent vasodilation<br>

Secondary Outcome Measures

Name	Time	Method
<br> 1. High-sensitive C-reactive protein measured using a commercially available kit at baseline, 3, and 6 months<br> 2. Periodontal pocket depth measured using the manual periodontal probe at baseline, 3, and 6 months<br> 3. Clinical attachment level measured using the manual periodontal probe at baseline, 3, and 6 months<br>