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

NCT ID: NCT05691426

Last Updated: 2023-01-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-10-01

Study Completion Date

2024-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Endothelial Dysfunction Periodontal Diseases

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Test

Periodontitis patients

Assessment of pulse wave amplitude (PWA)

Intervention Type DIAGNOSTIC_TEST

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

Salivary Nitric Oxide

Intervention Type DIAGNOSTIC_TEST

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

Control

Periodontally healthy patients

Assessment of pulse wave amplitude (PWA)

Intervention Type DIAGNOSTIC_TEST

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

Salivary Nitric Oxide

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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Assessment of pulse wave amplitude (PWA)

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

Intervention Type DIAGNOSTIC_TEST

Salivary Nitric Oxide

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Sharjah

OTHER

Sponsor Role lead

Responsible Party

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Zahi BADRAN

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Zahi Badran

Role: STUDY_DIRECTOR

University of Sharjah

Locations

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University Dental Hospital Sharjah

Sharjah city, , United Arab Emirates

Site Status RECRUITING

Countries

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United Arab Emirates

Central Contacts

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Zahi BADRAN, PhD

Role: CONTACT

0097165057353

Facility Contacts

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Zahi BADRAN

Role: primary

Other Identifiers

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REC-22-02-28-04-S

Identifier Type: -

Identifier Source: org_study_id

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