Correlation Between Periodontitis and Hypertension Among a Sample of Adult Egyptian Patients
NCT ID: NCT04634734
Last Updated: 2020-11-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
376 participants
OBSERVATIONAL
2020-12-01
2021-10-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
* 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).
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
ECOLOGIC_OR_COMMUNITY
CROSS_SECTIONAL
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Patients consulting in the outpatient clinic.
* Patients not receiving periodontal treatment within the previous four months.
* Provide informed consent.
Exclusion Criteria
* 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.
18 Years
70 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Cairo University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Ali Saleh Yousef Al-Hasan
Principle Investigator
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Correlation b/w Perio. & HBP
Identifier Type: -
Identifier Source: org_study_id