Obesity, Periodontal HealthNCT05676736
Impact of Obesity on Periodontal Health in a Sample of Adult Egyptian Patients: A Comparant Study
An observational study of Obesity, Periodontal Health, run by Cairo University at 1 site in Egypt.
Trial summary
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". Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Obesity, Periodontal Health
- How many people
- 384 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2022to 30 May 2023
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: - Dental patients will be recruited in a consecutive manner from the outpatient Diagnostic center, Faculty of Dentistry, Cairo University.
Who may be able to join
- 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.
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 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Obesity, Periodontal Health
- Being tested
- No intervention
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention to be done for the group
| Study group | Role | What they receive |
|---|---|---|
| Study group (S) Obese group | Patients with body mass index (BMI) range from (≥30 kg/m2) Receives: Other: No intervention | |
| Control group (C) Normal weight group | Patients with body mass index (BMI) range from (18.5-24.9 kg/m2) Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
- The primary outcome of the study is the periodontal health in association with obesity
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).
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2023
- Study start1 Dec 2022
- Primary completion20 Apr 2023
- Study completion30 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity, Periodontal HealthStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 384 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mai Zakaria Ibrahium Mohammed, Cairo University
- Investigators
- Mai Zakaria, ph, Principal investigator, Associate professor Oral Medicine & Periodontology, Faculty of Dentistry, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05676736
- Sponsor's protocol ID
- Mai Zakaria Protocol
- Status last verified
- Sep 2023
- First submitted
- 31 Dec 2022
- Last updated
- 21 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: individual participant data are not to be shared with other researchers until publication of the study.
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Obesity on Periodontal Health in a Sample of Adult Egyptian Patients: A Comparant Study
- ClinicalTrials.gov ID
- NCT05676736
- Acronym / sponsor ID
- Mai Zakaria Protocol
- Conditions
- Obesity, Periodontal Health
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 384 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 20 Apr 2023 (actual)
- Study completion
- 30 May 2023 (actual)
- First posted
- 9 Jan 2023 (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.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group (S) Obese group | – | Other: No interventionPatients with body mass index (BMI) range from (≥30 kg/m2) |
| Control group (C) Normal weight group | – | Other: No interventionPatients with body mass index (BMI) range from (18.5-24.9 kg/m2) |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo intervention to be done for the group | Other | Control group (C) Normal weight group, Study group (S) Obese group |
Primary outcome
- 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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2023.
- Individual participant dataSharing planned: No. individual participant data are not to be shared with other researchers until publication of the study.
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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.
Mai Zakaria, ph principal investigator
Associate professor Oral Medicine & Periodontology, Faculty of Dentistry, 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 Obesity, Periodontal Health, 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 6 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: finished, as of the sponsor's last update on 21 Sep 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
- The primary outcome of the study is the periodontal health in association with obesity (time frame: Day 1). 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 2023.