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

NCT05691426 | Unknown

• 1 other identifier: REC-22-02-28-04-S
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Endothelial Dysfunction; Periodontal Diseases

Outcome Measures

Primary Outcomes (1)

• pulse wave amplitude

  2 months

Study Arms (2)

Test

Periodontitis patients

Diagnostic Test: Assessment of pulse wave amplitude (PWA); Diagnostic Test: Salivary Nitric Oxide

Control

Periodontally healthy patients

Diagnostic Test: Assessment of pulse wave amplitude (PWA); Diagnostic Test: Salivary Nitric Oxide

Interventions

Assessment of pulse wave amplitude (PWA) DIAGNOSTIC_TEST

Assessment of pulse wave amplitude (PWA) through peripheral arterial tonometry (PAT) using the device EndoPAT (Itamar Medical)

Control; Test

Salivary Nitric Oxide DIAGNOSTIC_TEST

assessment the levels of salivary Nitric Oxide using a Nitric Oxide colorimetric detection kit,

Control; Test

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients recruited from the pool of patients consulting at Postgraduate teachingb clinics of the University Dental Hospital Sharjah

You may qualify if:

• Group 1: periodontally healthy subjects.
• Group 2: patients with periodontitis stage III or IV and grades A,B or C.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Sharjah: lead

Study Sites (1)

University Dental Hospital Sharjah

Sharjah city, United Arab Emirates

RECRUITING

MeSH Terms

Conditions

Periodontal Diseases

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Study Officials

• Zahi Badran

  University of Sharjah

  STUDY DIRECTOR

Central Study Contacts

Zahi BADRAN, PhD

CONTACT

0097165057353; zbadran@sharjah.ac.ae

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 10, 2023
• First Posted: January 20, 2023
• Study Start: October 1, 2022
• Primary Completion: December 1, 2023
• Study Completion: June 1, 2024
• Last Updated: January 25, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

AE (1)