AGE/sRAGE Ratio in Diabetic Periodontitis

NCT06516328 | Completed

• 1 other identifier: GO23/63
• Study Type: observational
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Periodontitis, Diabetes Mellitus Type 2

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (4)

healthy (H)

Periodontally and systemically healthy individuals

Other: Observational

Periodontitis (P)

Patients with periodontitis without diabetes

Other: Observational

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

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

Interventions

Observational OTHER

GCF and saliva samples obtained.

Diabetic Periodontitis (DP) group; Periodontitis (P); Poorly controlled Diabetic Periodontitis group (PDP); healthy (H)

Eligibility Criteria

• Age: 25 Years - 74 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Hacettepe University

Ankara, 06100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Periodontitis; Diabetes Mellitus, Type 2

Interventions

Watchful Waiting

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asistant Proffessor

Study Record Dates

• First Submitted: July 14, 2024
• First Posted: July 23, 2024
• Study Start: May 1, 2022
• Primary Completion: November 28, 2023
• Study Completion: December 10, 2023
• Last Updated: July 23, 2024

Record last verified: 2024-07

Locations

TU (1)