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AGE/sRAGE Ratio in Diabetic Periodontitis

H

Hacettepe University

Status

Completed

Conditions

Periodontitis, Diabetes Mellitus Type 2

Treatments

Other: Observational

Study type

Observational

Funder types

Other

Identifiers

NCT06516328
GO23/63

Details and patient eligibility

About

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.

Enrollment

64 patients

Sex

All

Ages

25 to 74 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • 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.

Exclusion criteria

  • having periodontal treatment in the last six months;
  • participants with smoking habit or history; and
  • usage of medicine that may affect study results (mouthwash, antibiotics, corticosteroid, statins etc.) three months before collecting dental plaque and GCF samples.
  • Lactating or pregnant patients
  • Patients with systemic diseases other than type 2 diabetes.

Trial design

64 participants in 4 patient groups

healthy (H)
Description:
Periodontally and systemically healthy individuals
Treatment:
Other: Observational
Periodontitis (P)
Description:
Patients with periodontitis without diabetes
Treatment:
Other: Observational
Diabetic Periodontitis (DP) group
Description:
Periodontitis patients with diabetes under control (Glycosylated hemoglobin (HbA1c) value ≤ 6.5% and fasting blood sugar levels \<200 mg/dl.)
Treatment:
Other: Observational
Poorly controlled Diabetic Periodontitis group (PDP)
Description:
Periodontitis patients with uncontrolled diabetes HbA1c value \> 6.5% and fasting blood sugar levels \> 200 mg/dl.
Treatment:
Other: Observational

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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