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Completed

NCT Number: NCT04891627

Gingival Crevicular IL-34 and CSF-1 Levels in Patients With Periodontitis and Uncontrolled Type 2 Diabetes

Type 2 diabetes mellitus is a metabolic disorder. There is a bidirectional association between periodontal disease and DM. Currently there is no data relationship between CSF-1 and IL-34, periodontal disease and diabetes.The aim of this study to investigate GCF levels of IL-34 and CSF-1 in periodontitis subjects with diabetes.

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Key information

Conditions

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

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Usak

Uşak, 64200, Turkey (Türkiye)

About this study

Periodontally healthy (H), periodontitis, and periodontitis with diabetes patients, were recruited for this study.

  • Inclusion criteria for H groups: Individuals with clinically healthy gingiva, no attachment and bone loss, and less than 10% bleeding on probing were included.
  • Inclusion criteria for periodontitis groups: Systemically healthy individuals with interdental CAL ≥ 5 mm and PPD ≥ 6 mm were included.
  • Inclusion criteria for periodontitis with diabetes groups: Type 2 diabetes patients with interdental CAL ≥ 5 mm, PPD ≥ 6 mm, and HbA1c ≥ 6.5% were included.

The plaque index (PI), gingival index (GI), presence of bleeding on probing (BOP), PD, and clinical AL were used for clinical periodontal assessments. All assessments were done with a manual probe. GCF samples were obtained and analyzed using an enzyme-linked immunosorbent assay.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • have 20 teeth
  • have diabetes .

Exclusion criteria

  • Individuals have systemic disease
  • smokers;
  • pregnant
  • those using drugs;

Treatment and study plan

gingival crevicular fluid

Diagnostic Test

GCF samples were collected in the morning hours 24-48 hours after clinical periodontal measurement.

Primary outcomes

  1. It was aimed to compare IL-34 levels by taking gingival crevicular fluid in systemic healthy, periodontitis and diabetic patients with periodontitis groups.

    Time frame: GCF samples taken within the 1. week after the clinical examination of the patient

    GCF was taken interproximal region.

Secondary outcomes

  1. It was aimed to compare CSF-1 levels by taking gingival crevicular fluid in systemic healthy, periodontitis and diabetic patients with periodontitis groups.

    Time frame: GCF samples taken within the 1. week after the clinical examination of the patient

    GCF was taken interproximal region.

Sponsors and collaborators

Lead sponsor

Uşak University

Other

Registry information

Official study title

Usak University Faculty of Dentistry

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
May 18, 2021
Registry last updated
Jan 12, 2023

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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