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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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.

Egypt1 site
  • Faculty of dentistry cairo university

    Cairo

    (+202) 23634965

Other trials in Egypt

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).

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.

  1. : 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.

  1. First posted11 Apr 2022
  2. Study startMay 2022 (estimated)
  3. Primary completion2 Mar 2023 (estimated)
  4. Study completion30 Mar 2023 (estimated)

Resources

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)
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

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.

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