GCF Levels of IL-1β and IL-6 in Gingivitis and Stage III-Grade C Periodontitis

NCT ID: NCT04689438

Last Updated: 2022-11-04

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

64 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-10-08

Study Completion Date

2020-12-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Periodontal diseases are chronic diseases that occur as a result of a violation of the balance between microbial dental plaque and the host response. Gingivitis is a disease characterized by inflammation of the gingiva that occurs in one or more areas without loss of attachments.1 in periodontitis, an inflammatory event that begins in the gingiva along with gingivitis spreads to the periodontal ligament, alveolar bone and soft tissues that support the tooth, causing the destruction of these structures.2 Cytokines are low molecular weight proteins that participate in the initial and active stages of inflammation and immunity. In periodontal disease pathogenesis, cytokine response has been reported to play a very critical role in determining disease progression.3 IL-1beta and IL-6 are key cytokines in chronic inflammatory diseases and have the potential to initiate bone loss and tissue destruction seen in periodontal disease.4the purpose of this study; it is to determine the degree of inflammation and periodontal destruction by determining the levels of IL-1beta and IL-6 cytokines in the gingival crevicular fluid of periodontal healthy and diseased individuals.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Periodontal measurement were done at 6 sites per tooth After clinical evaluation, individuals were divided into 3 groups

1. Healthy control groups:

clinically healthy gingiva
2. Gingivitis groups:

BOP score of 10% or greater and PD≤3mm
3. Periodontitis groups:

AL ≥5 mm, PD≥6 mm and tooth loss due to periodontitis of ≤4. GCF samples were collected using strips.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Periodontitis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Healthy control groups

clinically healthy gingiva BOP score less than 10%

gingival crevicular fluid

Intervention Type DIAGNOSTIC_TEST

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

Gingivitis groups

BOP score of 10% or greater

gingival crevicular fluid

Intervention Type DIAGNOSTIC_TEST

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

Periodontitis groups

interdental AL ≥5 mm, PD≥6 mm

gingival crevicular fluid

Intervention Type DIAGNOSTIC_TEST

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

gingival crevicular fluid

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* have periodontitis
* have 16 permanent teeth

Exclusion Criteria

* Systemic disease
* using drugs
Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Uşak University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Ahu Dikilitaş

Usak University Faculty of Dentistry

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

ahu dikilitaş

Role: PRINCIPAL_INVESTIGATOR

University of Usak

fatih karaaslan

Role: STUDY_CHAIR

University of Usak

abdullah seçkin ertuğrul

Role: STUDY_CHAIR

University of IZMIR KATİP CELEBİ

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Usak

Uşak, , Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

UsakU7

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.