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NCT05691426 Clinical Trial

Assessment of the Effect of Non-surgical Periodontal Treatment on Endothelial Function- a Prospective Study

Periodontal Diseases Clinical Trial

Official title:
Assessment of the Effect of Non-surgical Periodontal Treatment on Endothelial Function- a Prospective Study

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05691426
Other study ID # REC-22-02-28-04-S
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date October 1, 2022
Est. completion date June 2024

Study information
Verified date January 2023
Source University of Sharjah
Contact Zahi BADRAN, PhD
Phone 0097165057353
Email zbadran@sharjah.ac.ae
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

An association between periodontitis and endothelial dysfunction has been reported, suggesting that periodontitis presents an inflammatory burden to the cardiovascular system, that might lead to AVD. The study aims aim to assess whether non-surgical periodontal therapy enhances endothelial function in periodontitis patients using a non-invasive diagnostic device to assess endothelial function through PWA and the assessment of levels of salivary Endothelin-1, in a population of people in the UAE.

Recruitment information / eligibility
Status Recruiting
Enrollment 40
Est. completion date June 2024
Est. primary completion date December 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Group 1: periodontally healthy subjects. - Group 2: patients with periodontitis stage III or IV and grades A,B or C. Exclusion Criteria: - Medical conditions: Diabetes,pregnancy,obesity,renal disease,patients with cardiovascular diseases including hypertension,recent myocardial infarction or unstable angina (within 3 months),congestive heart failure,valvular heart disease - Heavy smokers(>10 cigarettes per day), - Regular administration of drugs resulting in gingival hyperplasia,root planning in the past 6 months - Regular administration of drugs resulting in gingival hyperplasia (such as cyclosporine and phenytoin) - Recent antibiotic use (in the past 3 months) - Non-surgical periodontal therapy in the past 6 monthsp

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Assessment of pulse wave amplitude (PWA)
Assessment of pulse wave amplitude (PWA) through peripheral arterial tonometry (PAT) using the device EndoPAT (Itamar Medical)
• Salivary Nitric Oxide
assessment the levels of salivary Nitric Oxide using a Nitric Oxide colorimetric detection kit,

Locations
Country Name City State
United Arab Emirates University Dental Hospital Sharjah Sharjah

Sponsors (1)
Lead Sponsor Collaborator
University of Sharjah

Country where clinical trial is conducted

United Arab Emirates, 

Outcome
Type Measure Description Time frame Safety issue
Primary pulse wave amplitude 2 months
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