- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05676736
Impact of Obesity on Periodontal Health in a Sample of Adult Egyptian Patients: A Comparant Study
September 18, 2023 updated by: Mai Zakaria Ibrahium Mohammed, Cairo University
Periodontal disease is defined as "an inflammatory disease of the tooth supportive structure caused by specific microorganisms or groups of specific microorganisms, resulting in progressive destruction of the periodontal ligament and alveolar bone with increased probing depth formation, recession, or both".
According to WHO, overweight and obesity are defined as abnormal or excessive fat accumulation that may impair health.
Body mass index (BMI) can be considered as an indicator of obesity-related health risks.
Obesity was considered a global epidemic problem by the World Health Organization in the 1990s as it has increased internationally over the last decades.
Based on review in 2003 the periodontal disease onset, progression and response to therapeutic interventions have been shown to be influenced by several systemic, local and environmental modifying factors and the data collected from the literature suggests that nutritional supplementation has been suggested as a possible influencing factor on periodontal status and wound healing.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
- Dental patients will be recruited in a consecutive manner from the outpatient Diagnostic center, Faculty of Dentistry, Cairo University.
- 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).
- A total number of 384 patients will be included in this study. The patient categorized as obese will serve as study group (S group) and the patients categorized as normal weight patients will serve as control group (C group).
- 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.
- 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.
Study Type
Observational
Enrollment (Actual)
384
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
-
-
-
Cairo, Egypt, 115
- Faculty of Dentistry, Cairo university
-
-
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 60 years (Adult)
Accepts Healthy Volunteers
No
Sampling Method
Probability Sample
Study Population
- Dental patients will be recruited in a consecutive manner from the outpatient Diagnostic center, Faculty of Dentistry, Cairo University.
Description
Inclusion Criteria:
- Patients whose age is between 18-60 years old.
- Provide informed consent.
- Patient have at least 20 natural teeth.
- Patient had no received periodontal treatment within previous 4 months.
Exclusion Criteria:
- Individuals with chronic systemic diseases such as cancer, osteoporosis, endocrine and hematological Pathologies.
- Patients having problem in opening their mouth or undergoing intermaxillary 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.
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
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Study group (S) Obese group
Patients with body mass index (BMI) range from (≥30 kg/m2)
|
No intervention to be done for the group
|
Control group (C) Normal weight group
Patients with body mass index (BMI) range from (18.5-24.9
kg/m2)
|
No intervention to be done for the group
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
- The primary outcome of the study is the periodontal health in association with obesity
Time Frame: Day 1
|
The periodontal health status evaluated by full mouth charting using UNC 15 peiodontal probe, including probing depth (PD), clinical attachment Level (CAL), bleeding on probing (BOP), plaque index (PI).
|
Day 1
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Mai Zakaria, ph, Associate professor Oral Medicine & Periodontology, Faculty of Dentistry, Cairo University
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 (Actual)
December 1, 2022
Primary Completion (Actual)
April 20, 2023
Study Completion (Actual)
May 30, 2023
Study Registration Dates
First Submitted
December 31, 2022
First Submitted That Met QC Criteria
January 6, 2023
First Posted (Actual)
January 9, 2023
Study Record Updates
Last Update Posted (Actual)
September 21, 2023
Last Update Submitted That Met QC Criteria
September 18, 2023
Last Verified
September 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Mai Zakaria Protocol
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
individual participant data are not to be shared with other researchers until publication of the study.
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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