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NCT Number: NCT06516328

AGE/sRAGE Ratio in Diabetic Periodontitis

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.

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Key information

Age range

25 year–74 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hacettepe University

Ankara, 06100, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Observational

Other

GCF and saliva samples obtained.

Primary outcomes

  1. AGEs/RAGE ratio, IL-17 level in GCF and saliva

    Time frame: 3 to 6 months

    AGEs to RAGE ratio comparison between study groups

  2. AGEs/RAGE ratio, IL-17 level in GCF and saliva

    Time frame: 3 to 6 months

    IL-17 level comparison between study groups

Sponsors and collaborators

Lead sponsor

Hacettepe University

Other

Registry information

Official study title

AGE/sRAGE and IL-17 Levels in Type 2 Diabetic Periodontitis Patients

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jul 23, 2024
Registry last updated
Jul 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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