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

NCT ID: NCT04891627

Last Updated: 2023-01-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

76 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-01-06

Study Completion Date

2021-05-04

Brief Summary

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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

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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.

Conditions

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Periodontitis Diabetes

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Healthy control groups

individuals with clinically healthy gingiva BOP score less than 10% and PD≤3mm

Gingival crevicular fluid

Intervention Type DIAGNOSTIC_TEST

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

Periodontitis group

interdental AL ≥5 mm

Gingival crevicular fluid

Intervention Type DIAGNOSTIC_TEST

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

Periodontitis with diabetes group

HbA1c ≥6.5%

Gingival crevicular fluid

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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Gingival crevicular fluid

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* have 20 teeth
* have diabetes .

Exclusion Criteria

* Individuals have systemic disease
* smokers;
* pregnant
* those using drugs;
Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Uşak University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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ahu dikilitas

Role: PRINCIPAL_INVESTIGATOR

University of Usak

Locations

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University of Usak

Uşak, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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Dikilitas A, Karaaslan F, Evirgen S, Ertugrul AS. Gingival crevicular fluid CSF-1 and IL-34 levels in patients with stage III grade C periodontitis and uncontrolled type 2 diabetes mellitus. J Periodontal Implant Sci. 2022 Dec;52(6):455-465. doi: 10.5051/jpis.2106260313. Epub 2022 Apr 12.

Reference Type DERIVED
PMID: 36468466 (View on PubMed)

Other Identifiers

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UsakU8

Identifier Type: -

Identifier Source: org_study_id

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