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Status unknownNCT04634734Updated Nov 27, 2020

Correlation Between Periodontitis and Hypertension Among a Sample of Adult Egyptian Patients

An observational study in Periodontitis, sponsored by Cairo University. Status unknown. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-11-27.

Sponsored by Cairo University · Observational

The sponsor has not verified this record recently (last verified Sep 2020), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Ecologic or community
Time perspective
Cross-sectional
Enrollment
376
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

Read the detailed description
  • Dental patients will be recruited in a consecutive manner from the outpatient Diagnostic center, Faculty of Dentistry, Cairo University.
  • Before the interview, the aim of the study will be explained to the patient and the patient's acceptance to participate in the survey will be received.
  • Full questionnaire will be filled, then full mouth periodontal examination and charting will be done for each patient.
  • The questionnaire will be filled through a face-to-face personal interview with the patient using simple, short, easily comprehended questions (Goulart A.C., Armani F. et al. 2017, Machado V., Aguilera E. M. et al. 2020). The questionnaire will be translated by a certified translator into Arabic and validated. All the interviews will be done by the same investigator.
  • Non-respondent patients or patients refusing to participate will be reported with the cause of their refusal.
  • The questionnaire which will be applied in study will include sociodemographic and medical questionnaires. These covariates will include gender, age, marital status (single, married/union of fact, divorced or widowed), occupation (student, employed, unemployed or retired) and smoking habits (current status: never, former, current). Education will be categorized according to the 2011 International Standard Classification of Education (ISCED-2011) (UNESCO 2012): no education (ISCED 0 level), elementary (ISCED 1-2 levels), middle (ISCED 3-4 levels), higher (ISCED 5- 8 levels) (ISCED 2011). Blood pressure will be measured at the clinic by automated sphygmomanometer device. Finally, measurements of height and weight will be taken at the clinical exam and body mass index (BMI) will be calculated as kg/m2.
  • 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), gingival recession depth (Rec) and radiographic X-Ray imaging.
  • Periodontitis case is defined according to the latest available EFP/AAP consensus. It will be defined if interdental CAL is detectable at ≥ 2 non-adjacent teeth, or buccal or oral CAL ≥ 3 mm with PPD > 3 mm at ≥ 2 teeth. Periodontitis staging will be defined according to severity and extent. Concerning severity, interdental CAL at the site of the greatest loss of 1-2 mm, 3-4 and ≥5 was considered as mild (Stage 1), moderate (Stage 2), and severe (Stage 3 and Stage 4), respectively (Tonetti, Greenwell et al. 2018).
02

Conditions studied

  • Periodontitis
03

In context

Periodontitis

1,635 studies on the registry are indexed under Periodontitis; 327 are open to participants now.

This study's planned enrollment of 376 is above the median of 90 across 428 observational studies indexed under Periodontitis.

Browse Periodontitis studies →

Lead sponsor

Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.

Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

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

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Observational model
Ecologic or community
Time perspective
Cross-sectional
Enrollment
376 participants (estimated)
Patient registry
No
06

What researchers measure

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.

    Time frame: Through study completion, an average of 1 year

Secondary outcomes

  1. Body mass index.

    to estimate the impact of overweight and obesity in periodontitis cases by body mass index (BMI); which is calculated as the body weight (kg) divided by the square of the height (m).

    Time frame: Through study completion, an average of 1 year

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 27, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04634734
Lead sponsor
Cairo University
Responsible party
Ali Saleh Yousef Al-Hasan (Principle Investigator, Cairo University) — Principal investigator
First posted
Nov 18, 2020
Start date
Dec 1, 2020 (estimated)
Primary completion
Oct 1, 2021 (estimated)
Completion
Oct 1, 2021 (estimated)
Last update
Nov 27, 2020

Study contacts

Ali S. Al-Hasan, Master
Contact
Ali.alhasan@dentistry.cu.edu.eg
+201222271218

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2020. You cannot join it, but the record below documents what was studied.

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