NCT04634734

Brief Summary

The study is a cross-sectional study investigating the correlation between periodontitis and both hypertension and body mass index among a sample of adult Egyptian dental patients attending diagnostic center at faculty of Dentistry, Cairo University.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
376

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2020

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 15, 2020

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 18, 2020

Completed
13 days until next milestone

Study Start

First participant enrolled

December 1, 2020

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2021

Completed
Last Updated

November 27, 2020

Status Verified

September 1, 2020

Enrollment Period

10 months

First QC Date

September 15, 2020

Last Update Submit

November 25, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Correlation between periodontitis and hypertension

    * Clinical examination will be held on a dental unit using the light of the unit and a mirror. Periodontal status will be evaluated by full mouth charting using UNC 15 periodontal probe, including assessment of plaque index (PI), bleeding on probing (BoP), Probing Depth (PD), Clinical Attachment Level (CAL) and digital radiographic imaging. * Periodontitis case is defined according to the latest available EFP/AAP consensus. * Blood pressure measured by using an automated sphygmomanometer device. hypertension will be defined as values of systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg, or; the use of antihypertensive medication. * Then a questionnaire will be collected to estimate the prevalence of hypertension in periodontitis Egyptians adult patients.

    Through study completion, an average of 1 year

Secondary Outcomes (1)

  • Body mass index.

    Through study completion, an average of 1 year

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Periodontitis adult patients with hypertension attending to diagnostic center at faculty of Dentistry, Cairo University.

You may qualify if:

  • Patients whose age is between 18-70 years old.
  • Patients consulting in the outpatient clinic.
  • Patients not receiving periodontal treatment within the previous four months.
  • Provide informed consent.

You may not qualify if:

  • Individuals with chronic systemic diseases such as endocrine, metabolic and hematological conditions.
  • Patients having problem in opening their mouth or undergoing inter-maxillary fixation where oral examination will not be possible.
  • Pregnant women.
  • Patients diagnosed with psychiatric problems or intoxicated with alcohol or drugs.
  • Patients consuming caffeine, doing exercise and smoking in the 30 min prior to blood pressure measurement.
  • Third molars, dental implants and retained roots.
  • Patients with orthodontic appliances.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Periodontitis

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic Diseases

Central Study Contacts

Ali S. Al-Hasan, Master

CONTACT

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

September 15, 2020

First Posted

November 18, 2020

Study Start

December 1, 2020

Primary Completion

October 1, 2021

Study Completion

October 1, 2021

Last Updated

November 27, 2020

Record last verified: 2020-09