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

Sponsor
University of Sharjah (Other)
Overall Status
Recruiting
CT.gov ID
NCT05691426
Collaborator
(none)
40
Enrollment
1
Location
20
Anticipated Duration (Months)
2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Assessment of pulse wave amplitude (PWA)
  • Diagnostic Test: Salivary Nitric Oxide

Study Design

Study Type:
Observational
Anticipated Enrollment :
40 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Assessment of the Effect of Non-surgical Periodontal Treatment on Endothelial Function- a Prospective Study
Actual Study Start Date :
Oct 1, 2022
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Jun 1, 2024

Arms and Interventions

Arm 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,

Outcome Measures

Primary Outcome Measures

  1. pulse wave amplitude [2 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University Dental Hospital Sharjah Sharjah United Arab Emirates

Sponsors and Collaborators

  • University of Sharjah

Investigators

  • Study Director: Zahi Badran, University of Sharjah

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Zahi BADRAN, Professor, University of Sharjah
ClinicalTrials.gov Identifier:
NCT05691426
Other Study ID Numbers:
  • REC-22-02-28-04-S
First Posted:
Jan 20, 2023
Last Update Posted:
Jan 25, 2023
Last Verified:
Jan 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Periodontal Diseases
Nitric Oxide

Study Results

No Results Posted as of Jan 25, 2023