- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04557670
Relationship Between Periodontal Health Status, Body Mass Index and Quality of Diet in a Sample of Adult Patients.
The Association Between Periodontal Health Status, Body Mass Index and Quality of Diet in a Sample of Adult Egyptian Patients. A Hospital Based Cross-sectional Study
The study is a cross-sectional study investigating the relationship between periodontal health condition, body mass index and quality of diet on adult Egyptian dental patients attending the oral diagnostic center at faculty of Dentistry, Cairo University.
The faculty of Dentistry, Cairo University is an open public facility, a tertiary healthcare and a referral center
Study Overview
Status
Conditions
Detailed Description
- Dental patients will be recruited in a consecutive manner from the outpatient Diagnostic center, Faculty of Dentistry, Cairo University.
- Medical history will be taken, thorough oral examination will be done, and a full questionnaire will be filled for each patient.
- Before filling the questionnaire, the aim of the study will be explained to the patient and the patient's acceptance to participate in the survey will be received.
- Non-respondent patients or patients refusing to participate will be reported with the cause of their refusal.
- The questionnaire will be filled through a face-to-face personal interview with the patient using simple, short, easily comprehended questions.
- Full questionnaire will be filled, then full mouth periodontal examination and charting will be done for each patient.
- The interview questions will be prepared in English, translated into Arabic and then reverse translated by a certified translator to ensure accuracy.
- All the interviews will be done by the same investigator.
- Convetional Clinical examination will be held on a dental unit using the light of the unit and a mirror.
- Periodontal health status will be evaluated by full mouth charting using UNC 15 periodontal probe, including assessment of Probing Depth (PD), Clinical Attachment Level (CAL), Bleeding on probing (BOP), plaque index (PI), body mass index (BMI) and health eating index (HEI).
The questionnaire which was applied in study will include the following:
- Questions including section for demographic information of age, gender, marital status, income, weight, length.
- Dietary habits were self-reported through completion of a short form of a validated food frequency questionnaire (Ruiz-Cabello et al., 2017).
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
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-
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Cairo, Egypt
- Recruiting
- Faculty of Oral and Dental Medicine-CU
-
Contact:
- Abdullah Al-shantub, Master
- Phone Number: 00201013993637
- Email: abdullah.alshentub@dentistry.cu.edu.eg
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients whose age is between 18-70 years old.
- Provide informed consent.
- Patient have at least 20 natural teeth.
- Patient had no received periodontal treatment within previous 4 months.
Exclusion Criteria:
- Individuals with chronic systemic diseases such as cancer, osteoporosis, endocrine and hematological Pathologies.
- 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 with orthodontic appliances.
- Patient had autoimmune condition.
- All patients require prophylaxis at least those attending the diagnostic center.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Periodontal health in association with Body mass index
Time Frame: An average of 1 year through study completion
|
(weight and height will be combined to report BMI in kg/m^2) - To estimate the level of overweight and obesity. commonly used the (BMI); was calculated as the body weight (kg) divided by the square of the height (m^2). |
An average of 1 year through study completion
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Quality of diet
Time Frame: An average of 1 year through study completion
|
- Dietary habits were self-reported through completion of a short form of a validated food frequency questionnaire. in which participants indicated the frequency of consumption (number of times per day, week, month, or year) of 34 foods divided by food groups: fruit, vegetables, dairy products, fish, cereals, pulses, eggs, meat, fats, sweets, beverages, and nuts.
|
An average of 1 year through study completion
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- PER1-1-1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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