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.
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.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of dentistry , Cairo Univeristy
Cairo
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.
- Conditions
- Periodontal Diseases
- Medical subject headings
- Periodontal Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
- First posted5 Nov 2020
- Study start28 Oct 2020
- Primary completionJan 2021 (estimated)
- Study completionOct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Periodontal DiseasesStudies of the same condition, open and under way.
- 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
- 314 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yasmine Abbas Elsayed
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yasmine Abbas Elsayed, Cairo University
- Investigators
- Noha Ayman Ghallab, Professor, Principal investigator, Cairo University
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
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Different Stages of Periodontal Diseases Among a Sample of Young Adult Obese Egyptian Patients: A Hospital Based Cross-Sectional Study
- ClinicalTrials.gov ID
- NCT04618068
- Acronym / sponsor ID
- 21252462
- Conditions
- Periodontal Diseases
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 314 participants (estimated)
- Lead sponsor
- Yasmine Abbas ElsayedUniversity, hospital or other
- Study start
- 28 Oct 2020 (actual)
- Primary completion
- Jan 2021 (estimated)
- Study completion
- Oct 2021 (estimated)
- First posted
- 5 Nov 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 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.
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.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 39 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
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
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
we need to know the prevalence of periodontal disease in obese Egyptian patients
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2020.
- Derived from this study: PubMed 37582775Abbas 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.
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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.
Noha Ayman Ghallab, Professor principal investigator
Cairo University
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 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.