Relationship Between Periodontal Health Status, Body Mass Index and Quality of Diet in a Sample of Adult Patients.

September 15, 2020 updated by: abdullah salem mohammed al-shantub, Cairo University

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

Unknown

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:

    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).

Study Type

Observational

Enrollment (Anticipated)

328

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Probability Sample

Study Population

Adult Egyptian dental outpatients attending the oral diagnostic center at faculty of Dentistry, Cairo University.

Description

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 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
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

This is where you will find people and organizations involved with this study.

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)

November 1, 2020

Primary Completion (Anticipated)

November 1, 2021

Study Completion (Anticipated)

November 1, 2021

Study Registration Dates

First Submitted

September 4, 2020

First Submitted That Met QC Criteria

September 15, 2020

First Posted (Actual)

September 21, 2020

Study Record Updates

Last Update Posted (Actual)

September 21, 2020

Last Update Submitted That Met QC Criteria

September 15, 2020

Last Verified

September 1, 2020

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)?

NO

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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