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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04618068
Other study ID # 21252462
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date October 28, 2020
Est. completion date October 2021

Study information

Verified date October 2020
Source Cairo University
Contact Noha Ayman Ghallab, Professor
Phone +201005263365
Email noha.ghallab@dentistry.cu.edu.eg
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 314
Est. completion date October 2021
Est. primary completion date January 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 39 Years
Eligibility Inclusion Criteria: 1. Patients whose age is between 18-39 years old as the strength and physical performance reach their peak from 18-39 years 2. Body mass index more than 30. 3. Patient consulting in the outpatient clinic. 4. Provide informed consent. Exclusion Criteria: 1. Patients who have a systemic disease or were on medication for any systemic disease/conditions. 2. Patients who received periodontal treatment or antibiotics for at least 3 months. 3. Completely edentulous or having removable prosthetic appliance. 4. Pregnant women or lactating mothers. 5. Patients having problem in opening their mouth or undergoing intermaxillary fixation where oral examination will not be possible.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Egypt Faculty of dentistry , Cairo Univeristy Cairo

Sponsors (1)

Lead Sponsor Collaborator
Yasmine Abbas Elsayed

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary The prevalence of periodontal disease in obese Egyptian patients we need to know the prevalence of periodontal disease in obese Egyptian patients after recruitment of required sample size , through study completion an average of one year
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