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

November 25, 2020 updated by: Ali Saleh Yousef Al-Hasan, Cairo University

Correlation Between Periodontitis and Hypertension Among a Sample of Adult Egyptian Patients: A Hospital-based Cross-Sectional Study

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.

Study Overview

Status

Unknown

Conditions

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).

Study Type

Observational

Enrollment (Anticipated)

376

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation between periodontitis and hypertension
Time Frame: Through study completion, an average of 1 year
  • 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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Body mass index.
Time Frame: Through study completion, an average of 1 year
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).
Through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

December 1, 2020

Primary Completion (Anticipated)

October 1, 2021

Study Completion (Anticipated)

October 1, 2021

Study Registration Dates

First Submitted

September 15, 2020

First Submitted That Met QC Criteria

November 16, 2020

First Posted (Actual)

November 18, 2020

Study Record Updates

Last Update Posted (Actual)

November 27, 2020

Last Update Submitted That Met QC Criteria

November 25, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • Correlation b/w Perio. & HBP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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