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

Completed

• Conditions: Periodontitis; Diabetes
• Interventions: Diagnostic Test: Gingival crevicular fluid

• Registration Number: NCT04891627
• Lead Sponsor: Uşak University

Brief Summary

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.

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 Timeline

• Study Start: 2021-01-06
• Primary Completion: 2021-04-21
• Study Completion: 2021-05-04
• Study First Submitted: 2021-05-13
• Study First Submitted QC: 2021-05-13
• Study First Posted: 2021-05-18
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-10
• Last Update Posted: 2023-01-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 76

Inclusion Criteria

• have 20 teeth
• have diabetes .

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Periodontitis group	Gingival crevicular fluid	interdental AL ≥5 mm
Healthy control groups	Gingival crevicular fluid	individuals with clinically healthy gingiva BOP score less than 10% and PD≤3mm
Periodontitis with diabetes group	Gingival crevicular fluid	HbA1c ≥6.5%

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of Usak; 🇹🇷 Uşak, Turkey