Conditions Influencing Health StatusNCT04557670
Relationship Between Periodontal Health Status, Body Mass Index and Quality of Diet in a Sample of Adult Patients.
An observational study of Conditions Influencing Health Status, run by Cairo University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Conditions Influencing Health Status
- How many people
- 328 participants
- Where
- 1 siteEgypt
- Study dates
- Nov 2020to Nov 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: Adult Egyptian dental outpatients attending the oral diagnostic center at faculty of Dentistry, Cairo University.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Oral and Dental Medicine-CU
Cairo
Abdullah Al-shantub, Master, 00201013993637, abdullah.alshentub@dentistry.cu.edu.eg
About this study
Official title: 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
Read the 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).
- Conditions
- Conditions Influencing Health Status
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: An average of 1 year through study completion
Secondary outcomes (1)
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.
Measured: An average of 1 year through study completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2020
- Study startNov 2020 (estimated)
- Primary completionNov 2021 (estimated)
- Study completionNov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Conditions Influencing Health StatusStudies 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
- 328 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, abdullah salem mohammed al-shantub, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04557670
- Sponsor's protocol ID
- PER1-1-1
- Status last verified
- Sep 2020
- First submitted
- 4 Sep 2020
- Last updated
- 21 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04557670
- Acronym / sponsor ID
- PER1-1-1
- Conditions
- Conditions Influencing Health Status
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 328 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Nov 2020 (estimated)
- Primary completion
- Nov 2021 (estimated)
- Study completion
- Nov 2021 (estimated)
- First posted
- 21 Sep 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 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
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 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
- Adult Egyptian dental outpatients attending the oral diagnostic center at faculty of Dentistry, Cairo University.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
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
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).
1 secondary outcome
Quality of diet
Time frame: An average of 1 year through study completion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2020.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Conditions Influencing Health Status, run by Cairo University at 1 site in Egypt.
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 21 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Abdullah al-shantub, Master (00201013993637, abdullah.alshentub@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Periodontal health in association with Body mass index (time frame: An average of 1 year through study completion). 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 21 Sep 2020.