Endothelial DysfunctionNCT05691426
Assessment of the Effect of Non-surgical Periodontal Treatment on Endothelial Function- a Prospective Study
An observational study of Endothelial Dysfunction and Periodontal Diseases, run by University of Sharjah at 1 site in United Arab Emirates.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Endothelial Dysfunction, Periodontal Diseases
- What is being tested?
- Assessment of pulse wave amplitude (PWA) and Salivary Nitric Oxide
- How many people
- 40 participants
- Where
- 1 siteUnited Arab Emirates
- Study dates
- 1 Oct 2022to Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients recruited from the pool of patients consulting at Postgraduate teachingb clinics of the University Dental Hospital Sharjah
Who may be able to join
- Group 1: periodontally healthy subjects.
- Group 2: patients with periodontitis stage III or IV and grades A,B or C.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Arab Emirates1 site, 1 recruiting
- Recruiting
University Dental Hospital Sharjah
Sharjah city
Zahi BADRAN, zbadran@sharjah.ac.ae
About this study
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
- Being tested
- Assessment of pulse wave amplitude (PWA), Salivary Nitric Oxide
- Medical subject headings
- Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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)
Salivary Nitric OxideDiagnostic test
assessment the levels of salivary Nitric Oxide using a Nitric Oxide colorimetric detection kit,
| Study group | Role | What they receive |
|---|---|---|
| Test | Periodontitis patients Receives: Diagnostic Test: Assessment of pulse wave amplitude (PWA); Diagnostic Test: Salivary Nitric Oxide | |
| Control | Periodontally healthy patients Receives: Diagnostic Test: Assessment of pulse wave amplitude (PWA); Diagnostic Test: Salivary Nitric Oxide |
What is being measured
The primary outcome is the main question the study is designed to answer.
pulse wave amplitude
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2023
- Study start1 Oct 2022
- Primary completionDec 2023 (estimated)
- Study completionJun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endothelial DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sharjah
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zahi BADRAN, University of Sharjah
- Investigators
- Zahi Badran, Study director, University of Sharjah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05691426
- Sponsor's protocol ID
- REC-22-02-28-04-S
- Status last verified
- Jan 2023
- First submitted
- 10 Jan 2023
- Last updated
- 25 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Effect of Non-surgical Periodontal Treatment on Endothelial Function- a Prospective Study
- ClinicalTrials.gov ID
- NCT05691426
- Acronym / sponsor ID
- REC-22-02-28-04-S
- Conditions
- Endothelial Dysfunction, Periodontal Diseases
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of SharjahUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Jun 2024 (estimated)
- First posted
- 20 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test | – | Diagnostic Test: Assessment of pulse wave amplitude (PWA), Diagnostic Test: Salivary Nitric OxidePeriodontitis patients |
| Control | – | Diagnostic Test: Assessment of pulse wave amplitude (PWA), Diagnostic Test: Salivary Nitric OxidePeriodontally healthy patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients recruited from the pool of patients consulting at Postgraduate teachingb clinics of the University Dental Hospital Sharjah
Key inclusion criteria (2 listed)
- Group 1: periodontally healthy subjects.
- Group 2: patients with periodontitis stage III or IV and grades A,B or C.
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Control, Test |
| Salivary Nitric Oxideassessment the levels of salivary Nitric Oxide using a Nitric Oxide colorimetric detection kit, | Diagnostic test | Control, Test |
Primary outcome
pulse wave amplitude
Time frame: 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zahi Badran study director
University of Sharjah
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endothelial Dysfunction and Periodontal Diseases, run by University of Sharjah at 1 site in United Arab Emirates.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Arab Emirates. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zahi BADRAN, PhD (0097165057353, zbadran@sharjah.ac.ae), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pulse wave amplitude (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2023.