PeriodontitisNCT04634734
Correlation Between Periodontitis and Hypertension Among a Sample of Adult Egyptian Patients
An observational study of Periodontitis, run by Cairo University.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontitis
- How many people
- 376 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2020to 1 Oct 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Periodontitis adult patients with hypertension attending to diagnostic center at faculty of Dentistry, Cairo University.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
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).
- Conditions
- Periodontitis
- Medical subject headings
- Periodontitis
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2020
- Study start1 Dec 2020 (estimated)
- Primary completion1 Oct 2021 (estimated)
- Study completion1 Oct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PeriodontitisStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 376 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali Saleh Yousef Al-Hasan, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04634734
- Sponsor's protocol ID
- Correlation b/w Perio. & HBP
- Status last verified
- Sep 2020
- First submitted
- 15 Sep 2020
- Last updated
- 27 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Periodontitis and Hypertension Among a Sample of Adult Egyptian Patients: A Hospital-based Cross-Sectional Study
- ClinicalTrials.gov ID
- NCT04634734
- Acronym / sponsor ID
- Correlation b/w Perio. & HBP
- Conditions
- Periodontitis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 376 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Dec 2020 (estimated)
- Primary completion
- 1 Oct 2021 (estimated)
- Study completion
- 1 Oct 2021 (estimated)
- First posted
- 18 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Periodontitis adult patients with hypertension attending to diagnostic center at faculty of Dentistry, Cairo University.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Body mass index.
Time frame: Through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Periodontitis, run by Cairo University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ali S. Al-Hasan, Master (+201222271218, Ali.alhasan@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between periodontitis and hypertension (time frame: Through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2020.