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

Diabetes Clinical Trial

Official title:

Usak University Faculty of Dentistry

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04891627
• Other study ID #: UsakU8
• Status: Completed
• Start date: January 6, 2021
• Est. completion date: May 4, 2021

Study information

• Verified date: January 2023
• Source: Usak University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: May 4, 2021
• Est. primary completion date: April 21, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

Inclusion Criteria:

• have 20 teeth
• have diabetes .

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Diabetes
• Periodontitis

Intervention

Diagnostic Test:
• Gingival crevicular fluid
GCF samples were collected in the morning hours 24-48 hours after clinical periodontal measurement.

Locations

Country	Name	City	State
Turkey	University of Usak	Usak

Sponsors (1)

Lead Sponsor	Collaborator
Usak University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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