PeriodontitisNCT05322369
Prevalence of Periodontitis in Diabetic Patients of Egyptian Population
An observational study of Periodontitis and Diabetes, run by Cairo University at 1 site in Egypt.
Trial summary
The study aims at determining the prevalence of Periodontitis in diabetic Egyptian dental outpatients attending the diagnostic centre at faculty of Dentistry, Cairo University Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Periodontitis, Diabetes
- What is being tested?
- periodontal charting only
- How many people
- 447 participants
- Where
- 1 siteEgypt
- Study dates
- May 2022to 30 Mar 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Diabetic Egyptian patients attending the outpatient diagnostic center of the faculty of dentistry, Cairo University
Who may be able to join
- Diabetic patients whether Type 1 or 2
- Patient consulting in the outpatient clinic
- Provide informed consent.
Who cannot join
- Participants who had <10 teeth currently or
- Those who had undergone any periodontal treatment within the past 1 year
- Patients suffering from any other metabolic or systemic diseses tht could affect the periodontal condition
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prevalence of Periodontitis in Diabetic Patients of Egyptian Population : A Cross Sectional Study.
The study aims at determining the prevalence of Periodontitis in diabetic Egyptian dental outpatients attending the diagnostic centre at faculty of Dentistry, Cairo University
Read the detailed description
Periodontitis is a common chronic inflammatory disease which is characterized by destruction of the supporting structures of the teeth especially the periodontal ligament and alveolar bone. Their classification is complex and takes into consideration many factors such as the clinical presentation, age at diagnosis, rate of disease progression, and systemic and local factors which may increase risk (Pihlstrom BL etal., 2005).
Tissue destruction in periodontitis results in the breakdown of the collagen fibers of the periodontal ligament, that results in the formation of a periodontal pocket between the gingiva and the tooth. "Pocketing" is not evident on simple visual inspection, and assessment using a periodontal probe is needed. Periodontitis is a slowly progressing disease, however the tissue destruction that happens is largely irreversible. The condition is asymptomatic in the early stages, it is not usually painful, and many patients are unaware till progression in the condition occurs and is enough to result in tooth mobility. As a result of the further destruction of fibers of the periodontal ligament (referred to as attachment loss), the pockets deepen, and the resorption of the alveolar bone occurs in parallel with the progressing attachment loss (Grossi SG etal., 1995).
Diabetes mellitus is a metabolic disorder which is characterized by hyperglycemia as a result of defective secretion or activity of insulin (Tan M etal., 1997). It may be further complicated by poor regulation of protein and lipid metabolism. In the current classification of this condition, the terms "insulin-dependent diabetes mellitus" and "non-insulin dependent diabetes mellitus" are not used, in part because they relate to treatment rather than to the diagnosis. A conclusive diagnosis of diabetes mellitus is done through assessment of glycated hemoglobin levels. In those people with diabetes, sequential fasting plasma glucose levels will be 7 mmol/L or more.
Type 1 diabetes mellitus normally occurs as a result of destruction of the beta cells in the islets of Langerhans of the pancreas by the autoimmune system. This condition often leads to absolute deficiency of insulin. Type 1 diabetes tends to occur in young, lean individuals, usually before 30 years of age; however, older patients may also present with this form of diabetes occasionaly.
With Type 2 diabetes, patients can still produce insulin but do so relatively inadequately. In many cases, the pancreas produces larger than normal quantities of insulin. A major feature of Type 2 diabetes is a lack of sensitivity to insulin by the cells of the body, especially fat and muscle cells. These larger quantities of insulin are produced as an attempt to get these cells to recognize that insulin is present.
There is emerging evidence to support the existence of a two-way relationship between diabetes and periodontitis, with diabetes increasing the risk for periodontitis, and periodontal inflammation negatively affecting glycemic control (Fox CH., 1992) \& (Mealey BL \& Ocampo GL, 2007).
- Conditions
- Periodontitis, Diabetes
- Being tested
- periodontal charting only
- Medical subject headings
- Periodontitis, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
periodontal charting onlyOther
Periodontal charting only
What is being measured
The primary outcome is the main question the study is designed to answer.
: Prevalence of Periodontitis in diabetics of Egyptian outpatients of faculty of dentistry cairo university.
periodontal charting will be done for diabetic patients attending outpatient clinics
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2022
- Study startMay 2022 (estimated)
- Primary completion2 Mar 2023 (estimated)
- Study completion30 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PeriodontitisStudies 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
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 447 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Reda Refaiy Basuony, Cairo University
- Investigators
- Mahmoud R Reda, BDS, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05322369
- Sponsor's protocol ID
- Periodontitis in diabetics
- Status last verified
- May 2022
- First submitted
- 4 Apr 2022
- Last updated
- 27 May 2022
- Results posted
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Periodontitis in Diabetic Patients of Egyptian Population : A Cross Sectional Study.
- ClinicalTrials.gov ID
- NCT05322369
- Acronym / sponsor ID
- Periodontitis in diabetics
- Conditions
- Periodontitis, Diabetes
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 447 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- May 2022 (estimated)
- Primary completion
- 2 Mar 2023 (estimated)
- Study completion
- 30 Mar 2023 (estimated)
- First posted
- 11 Apr 2022 (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 aims at determining the prevalence of Periodontitis in diabetic Egyptian dental outpatients attending the diagnostic centre at faculty of Dentistry, Cairo University
Detailed description
Periodontitis is a common chronic inflammatory disease which is characterized by destruction of the supporting structures of the teeth especially the periodontal ligament and alveolar bone. Their classification is complex and takes into consideration many factors such as the clinical presentation, age at diagnosis, rate of disease progression, and systemic and local factors which may increase risk (Pihlstrom BL etal., 2005).
Tissue destruction in periodontitis results in the breakdown of the collagen fibers of the periodontal ligament, that results in the formation of a periodontal pocket between the gingiva and the tooth. "Pocketing" is not evident on simple visual inspection, and assessment using a periodontal probe is needed. Periodontitis is a slowly progressing disease, however the tissue destruction that happens is largely irreversible. The condition is asymptomatic in the early stages, it is not usually painful, and many patients are unaware till progression in the condition occurs and is enough to result in tooth mobility. As a result of the further destruction of fibers of the periodontal ligament (referred to as attachment loss), the pockets deepen, and the resorption of the alveolar bone occurs in parallel with the progressing attachment loss (Grossi SG etal., 1995).
Diabetes mellitus is a metabolic disorder which is characterized by hyperglycemia as a result of defective secretion or activity of insulin (Tan M etal., 1997). It may be further complicated by poor regulation of protein and lipid metabolism. In the current classification of this condition, the terms "insulin-dependent diabetes mellitus" and "non-insulin dependent diabetes mellitus" are not used, in part because they relate to treatment rather than to the diagnosis. A conclusive diagnosis of diabetes mellitus is done through assessment of glycated hemoglobin levels. In those people with diabetes, sequential fasting plasma glucose levels will be 7 mmol/L or more.
Type 1 diabetes mellitus normally occurs as a result of destruction of the beta cells in the islets of Langerhans of the pancreas by the autoimmune system. This condition often leads to absolute deficiency of insulin. Type 1 diabetes tends to occur in young, lean individuals, usually before 30 years of age; however, older patients may also present with this form of diabetes occasionaly.
With Type 2 diabetes, patients can still produce insulin but do so relatively inadequately. In many cases, the pancreas produces larger than normal quantities of insulin. A major feature of Type 2 diabetes is a lack of sensitivity to insulin by the cells of the body, especially fat and muscle cells. These larger quantities of insulin are produced as an attempt to get these cells to recognize that insulin is present.
There is emerging evidence to support the existence of a two-way relationship between diabetes and periodontitis, with diabetes increasing the risk for periodontitis, and periodontal inflammation negatively affecting glycemic control (Fox CH., 1992) \& (Mealey BL \& Ocampo GL, 2007).
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Diabetic Egyptian patients attending the outpatient diagnostic center of the faculty of dentistry, Cairo University
Key inclusion criteria (3 listed)
- Diabetic patients whether Type 1 or 2
- Patient consulting in the outpatient clinic
- Provide informed consent.
Key exclusion criteria (3 listed)
- Participants who had <10 teeth currently or
- Those who had undergone any periodontal treatment within the past 1 year
- Patients suffering from any other metabolic or systemic diseses tht could affect the periodontal condition
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 |
|---|---|---|
| periodontal charting onlyPeriodontal charting only | Other | – |
Primary outcome
: Prevalence of Periodontitis in diabetics of Egyptian outpatients of faculty of dentistry cairo university.
Time frame: Baseline
periodontal charting will be done for diabetic patients attending outpatient clinics
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2022.
- Individual participant dataSharing planned: Undecided
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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.
Mahmoud R Reda, BDS 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 Periodontitis and Diabetes, 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 3 inclusion and 3 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 27 May 2022. 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 Mahmoud R Reda, BDS (+201002741736, mahmoud.refaiy@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
: Prevalence of Periodontitis in diabetics of Egyptian outpatients of faculty of dentistry cairo university. (time frame: Baseline). 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 27 May 2022.