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

Usak University Faculty of Dentistry

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.

Study Overview

• Status: Completed
• Conditions: Diabetes; Periodontitis
• Intervention / Treatment: Diagnostic test: Gingival crevicular fluid

Detailed Description

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

1. Inclusion criteria for H groups: Individuals with clinically healthy gingiva, no attachment and bone loss, and less than 10% bleeding on probing were included.
2. Inclusion criteria for periodontitis groups: Systemically healthy individuals with interdental CAL ≥ 5 mm and PPD ≥ 6 mm were included.
3. 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.

• Study Type: Observational
• Enrollment (Actual): 76

Contacts and Locations

Study Locations

• Turkey
  • Uşak, Turkey, 64200
    • University of Usak

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

individuals have diabetes and periodontitis

Description

Inclusion Criteria:

• have 20 teeth
• have diabetes .

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Healthy control groups; individuals with clinically healthy gingiva BOP score less than 10% and PD≤3mm	Diagnostic test: Gingival crevicular fluid; GCF samples were collected in the morning hours 24-48 hours after clinical periodontal measurement.
Periodontitis group; interdental AL ≥5 mm	Diagnostic test: Gingival crevicular fluid; GCF samples were collected in the morning hours 24-48 hours after clinical periodontal measurement.
Periodontitis with diabetes group; HbA1c ≥6.5%	Diagnostic test: Gingival crevicular fluid; GCF samples were collected in the morning hours 24-48 hours after clinical periodontal measurement.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
It was aimed to compare IL-34 levels by taking gingival crevicular fluid in systemic healthy, periodontitis and diabetic patients with periodontitis groups.	GCF was taken interproximal region.	GCF samples taken within the 1. week after the clinical examination of the patient

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
It was aimed to compare CSF-1 levels by taking gingival crevicular fluid in systemic healthy, periodontitis and diabetic patients with periodontitis groups.	GCF was taken interproximal region.	GCF samples taken within the 1. week after the clinical examination of the patient

Collaborators and Investigators

• Sponsor: Uşak University
• Investigators: Principal Investigator: ahu dikilitaş, University of Usak

Study record dates

Study Major Dates

• Study Start (Actual): January 6, 2021
• Primary Completion (Actual): April 21, 2021
• Study Completion (Actual): May 4, 2021

Study Registration Dates

• First Submitted: May 13, 2021
• First Submitted That Met QC Criteria: May 13, 2021
• First Posted (Actual): May 18, 2021

Study Record Updates

• Last Update Posted (Actual): January 12, 2023
• Last Update Submitted That Met QC Criteria: January 10, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: periodontitis; cytokines; Diabetes,
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis
• Other Study ID Numbers: UsakU8

Drug and device information, study documents

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