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Periodontal DiseasesNCT04618068

Prevalence of Periodontal Diseases Among Obese Egyptian Patients

An observational study of Periodontal Diseases, run by Yasmine Abbas Elsayed at 1 site in Egypt.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The study is a cross-sectional survey investigating the Prevalence of Different Stages of Periodontal Diseases among a sample of Young Adult Obese Egyptian patients attending the oral diagnosis clinic at faculty of Dentistry, Cairo University. Read more about this study

Who is it for?
Ages 18 to 39 yearsHealthy volunteers can take part
Conditions the study is for
Periodontal Diseases
How many people
314 participants
Where
1 siteEgypt
Study dates
28 Oct 2020to 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 39 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Study population: 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. The questionnaire will be filled through a face-to-face personal interview with the patient using simple, short, easily comprehended questions. It will include a section for demographic information of age, sex, social and educational of the patient. It will include questions about medical condition, habits of trauma, smoking and its frequency.

Who may be able to join

  • Patients whose age is between 18-39 years old as the strength and physical performance reach their peak from 18-39 years
  • Body mass index more than 30.
  • Patient consulting in the outpatient clinic.
  • Provide informed consent.

Who cannot join

  • Patients who have a systemic disease or were on medication for any systemic disease/conditions.
  • Patients who received periodontal treatment or antibiotics for at least 3 months.
  • Completely edentulous or having removable prosthetic appliance.
  • Pregnant women or lactating mothers.
  • Patients having problem in opening their mouth or undergoing intermaxillary fixation where oral examination will not be possible.

Trial locations and contacts

1 site in 1 country.

Noha Ayman Ghallab, Professor contact

+201005263365

noha.ghallab@dentistry.cu.edu.eg

Egypt1 site, 1 recruiting
  • Faculty of dentistry , Cairo Univeristy

    Cairo

    Recruiting

Other trials in Egypt

About this study

Official title: Prevalence of Different Stages of Periodontal Diseases Among a Sample of Young Adult Obese Egyptian Patients: A Hospital Based Cross-Sectional Study

The study is a cross-sectional survey investigating the Prevalence of Different Stages of Periodontal Diseases among a sample of Young Adult Obese Egyptian patients attending the oral diagnosis clinic at faculty of Dentistry, Cairo University.

Read the detailed description

In recent years, research has focused on the relationship between periodontitis and systemic disorders such as diabetes mellitus, rheumatoid arthritis, cardiovascular diseases and obesity. Obesity is the result of many disorders arising from several different causes, including complex interactions among genetic, biochemical, neural and psychological factors as well as environmental, social and economic factors. Moreover, obesity is considered itself a risk factor for several diseases, such as type 2 diabetes mellitus, cardiovascular disease, tumors and potentially for periodontal disease.

Obesity has a significant association with periodontitis in terms of body mass index (BMI), waist-to-hip circumference ratio, body fat, and maximum oxygen consumption. The BMI has always been considered a simple method for analysis of the nutritional status by world health organization. In 2014, the world health organization (WHO) estimated that around 600 million obese adults worldwide were obese and a further increase is expected in the future due to increased consumption of high-calorie diets and a sedentary lifestyle.

A bidirectional relationship links metabolic disorders like type 2 diabetes or obesity and periodontitis The common soil between these chronic conditions is likely to be systemic, low-grade inflammation: dental plaque releases bioactive products, which in turn stimulate host responses at the gingival and systemic level, promoting the release of inflammatory cytokines. These mediators are implicated in insulin resistance, impaired β-cell function, endothelial dysfunction, driving diabetes onset and the accelerating atherosclerosis marking it.

The association between obesity and periodontitis is one of the most recent fields of research in periodontal medicine and the possible underlying biological mechanisms remain unclear. Since then, the hypothesis that obesity is a risk factor for periodontitis has been evidenced by several epidemiological studies. The visceral adipose tissue has been shown to act as an organ that secretes important bioactive substances termed adipocytokines, including tumor necrosis factor alpha, which may affect periodontal disease pathogenesis

A recent study has shown that in a population young adults, tumor necrosis factor levels in gingival crevicular fluid correlate with individuals with BMI greater than forty. The authors suggested that obesity is type of low grade systemic inflammatory disease affecting periodontal disease progression. The systemic inflammation associated with obesity may increase susceptibility to chronic infectious diseases, which may explain how obesity would affect the development of periodontal diseases. However, whether obesity and overweight are associated with periodontitis is still under debate.

Many clinical studies have shown that overweight status, obesity, weight gain, and increased waist circumference are risk factors for the development of periodontitis or the worsening of periodontal status. Patients presenting moderate and severe periodontal disease have been found to produce higher systemic levels of inflammatory and immune markers. Treatment of periodontal disease can reduce these markers. Since the first report suggesting in a rat models existence of a possible relation between obesity and periodontal disease in 1977, only 21 years later, the first human study on the Japanese population, revealing that obese subjects showed a probability of suffering from periodontitis 8.6 times greater than non-obese ones.

Medical subject headings
Periodontal Diseases

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The prevalence of periodontal disease in obese Egyptian patients

    we need to know the prevalence of periodontal disease in obese Egyptian patients

    Measured: after recruitment of required sample size , through study completion an average of one year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Nov 2020
  2. Study start28 Oct 2020
  3. Primary completionJan 2021 (estimated)
  4. Study completionOct 2021 (estimated)

Resources

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
314 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04618068
Sponsor's protocol ID
21252462
Status last verified
Oct 2020
First submitted
31 Oct 2020
Last updated
5 Nov 2020
Results posted
No
Data monitoring committee
Yes

Publications

  • Abbas Y, Elsaadany B, Ghallab N. Prevalence of different stages of periodontal diseases among a sample of young adult obese Egyptian patients: a hospital based Cross-sectional study over 1 year. BMC Oral Health. 2023 Aug 16;23(1):573. doi: 10.1186/s12903-023-03278-3.

    PubMed 37582775

Questions about this trial

What is this clinical trial studying?

An observational study of Periodontal Diseases, run by Yasmine Abbas Elsayed 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 5 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 5 Nov 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 Noha Ayman Ghallab, Professor (+201005263365, noha.ghallab@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The prevalence of periodontal disease in obese Egyptian patients (time frame: after recruitment of required sample size , through study completion an average of one year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04618068, which also lists 1 linked publication.

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 5 Nov 2020.

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