NCT06516328Completed
AGE/sRAGE Ratio in Diabetic Periodontitis
AGE/sRAGE and IL-17 Levels in Type 2 Diabetic Periodontitis Patients
Source: ClinicalTrials.gov · Last updated 23 Jul 2024
Brief summary (registry, in English)
The goal of this observational study is to learn about some molecules in the disease mechanism of type 2 diabetes and periodontitis. There are end products inside the body called AGEs and their receptors binding to them especially (sRAGE, RAGE) in people with diabetes in hyperglycemic state.These molecules are important also in periodontitis (the disease of teeth that may end with exfoliation of the tooth). Diabetes and periodontitis enhance each other's disease-causing effects. Both is chronic inflammatory diseases and IL-17 is another molecule having role in this process. Totally 64 men and women aged between 27-60 included in the study. Study groups were : 1.participants with healthy teeth and no diabetes, 2. participants with periodontitis without diabetes, 3.participants with periodontitis and controlled diabetes, 4.participants with periodontitis and uncontrolled diabetes (6.5% and fasting blood sugar levels \<200 mg/dl). Researchers got saliva and gingival crevicular fluid (GCF) samples from diseased teeth and examined AGE, sRAGE, IL-17 levels. GCF is a fluid around the crevice of the theeth with different characteristics from saliva. As a result AGE/sRAGE ratio and IL-17 levels of diseased groups were higher than healthy group, while sRAGE levels were significantly lower in GCF samples. Researchers concluded that GCF and saliva AGE/sRAGE ratio may represent as a biomarker in periodontitis patients with uncontrolled diabetes.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 64 (actual)
- First submitted
- 14 Jul 2024
- Start date
- 1 May 2022
- Primary completion date
- 28 Nov 2023
- Lead sponsor
- Hacettepe University
- Diseases
- Type 2 diabetes
- NCT number
- NCT06516328
What you commit to
- Study type: Observational
- Participants enrolled: 64
- From 1 May 2022 to the primary completion date, 28 Nov 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- usage of medicine that may affect study results (mouthwash, antibiotics, corticosteroid, statins etc.) three months before collecting dental plaque and GCF samples.
Other illness
- Patients with systemic diseases other than type 2 diabetes.
Other
- having periodontal treatment in the last six months;
- participants with smoking habit or history; and
- Lactating or pregnant patients
Who the study is looking for
- Having interdental attachment loss in at least two non-adjacent teeth, or with \>3 mm of attachment loss in the buccal or palatal/lingual region with \>3 mm probing depth in at least two teeth for periodontitis groups.
- Having minimum 5mm or more pocket depth in at least 6 periodontal pockets.
- HbA1c value ≤ 6.5% and fasting blood sugar levels \<200 mg/dl for the controlled diabetes group.
- HbA1c value \> 6.5% and fasting blood sugar levels \> 200 mg/dl for uncontrolled diabetes group.
Age in the registry: 25 years to 74 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hacettepe University Coordinator of this site? Confirm its status | Ankara | Turkey (Türkiye) | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.