AGE/sRAGE Ratio in Diabetic Periodontitis

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

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.

Study Overview

• Status: Completed
• Conditions: Periodontitis, Diabetes Mellitus Type 2
• Intervention / Treatment: Other: Observational

• Study Type: Observational
• Enrollment (Actual): 64

Contacts and Locations

Study Locations

• Turkey
  • Ankara, Turkey, 06100
    • Hacettepe University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

The study population consisted of participants who applied to Hacettepe University Department of Periodontology and Hacettepe University Department of Endocrinology and Metabolism. Patients who agreed to participate in the study gave their written informed consent were included.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AGEs/RAGE ratio, IL-17 level in GCF and saliva	AGEs to RAGE ratio comparison between study groups	3 to 6 months
AGEs/RAGE ratio, IL-17 level in GCF and saliva	IL-17 level comparison between study groups	3 to 6 months

Collaborators and Investigators

• Sponsor: Hacettepe University

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2022
• Primary Completion (Actual): November 28, 2023
• Study Completion (Actual): December 10, 2023

Study Registration Dates

• First Submitted: July 14, 2024
• First Submitted That Met QC Criteria: July 18, 2024
• First Posted (Actual): July 23, 2024

Study Record Updates

• Last Update Posted (Actual): July 23, 2024
• Last Update Submitted That Met QC Criteria: July 18, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Diabetes Mellitus, Type 2; Periodontitis
• Other Study ID Numbers: GO23/63

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No