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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04557670
Other study ID # PER1-1-1
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date November 2020
Est. completion date November 2021

Study information

Verified date September 2020
Source Cairo University
Contact Abdullah al-shantub, Master
Phone 00201013993637
Email abdullah.alshentub@dentistry.cu.edu.eg
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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


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:

1. Questions including section for demographic information of age, gender, marital status, income, weight, length.

2. Dietary habits were self-reported through completion of a short form of a validated food frequency questionnaire (Ruiz-Cabello et al., 2017).


Recruitment information / eligibility

Status Recruiting
Enrollment 328
Est. completion date November 2021
Est. primary completion date November 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

1. Patients whose age is between 18-70 years old.

2. Provide informed consent.

3. Patient have at least 20 natural teeth.

4. Patient had no received periodontal treatment within previous 4 months.

Exclusion Criteria:

1. Individuals with chronic systemic diseases such as cancer, osteoporosis, endocrine and hematological Pathologies.

2. Patients having problem in opening their mouth or undergoing inter-maxillary fixation where oral examination will not be possible.

3. Pregnant women.

4. Patients diagnosed with psychiatric problems or intoxicated with alcohol or drugs.

5. Patients with orthodontic appliances.

6. Patient had autoimmune condition.

7. All patients require prophylaxis at least those attending the diagnostic center.

Study Design


Related Conditions & MeSH terms

  • Conditions Influencing Health Status

Locations

Country Name City State
Egypt Faculty of Oral and Dental Medicine-CU Cairo

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Periodontal health in association with Body mass index (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 Quality of diet - 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
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