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

January 21, 2023 updated by: Zahi BADRAN, University of Sharjah
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Test
Periodontitis patients
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)
Diagnostic test: Salivary Nitric Oxide
assessment the levels of salivary Nitric Oxide using a Nitric Oxide colorimetric detection kit,
Control
Periodontally healthy patients
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)
Diagnostic test: Salivary Nitric Oxide
assessment the levels of salivary Nitric Oxide using a Nitric Oxide colorimetric detection kit,

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
pulse wave amplitude
Time Frame: 2 months
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sharjah

Investigators

  • Study Director: Zahi Badran, University of Sharjah

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2022

Primary Completion (Anticipated)

December 1, 2023

Study Completion (Anticipated)

June 1, 2024

Study Registration Dates

First Submitted

January 10, 2023

First Submitted That Met QC Criteria

January 10, 2023

First Posted (Actual)

January 20, 2023

Study Record Updates

Last Update Posted (Estimate)

January 24, 2023

Last Update Submitted That Met QC Criteria

January 21, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REC-22-02-28-04-S

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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