- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04634734
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
|
|
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.
Sponsor
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
Additional Relevant MeSH Terms
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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