NCT04689438

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 8, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 25, 2020

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

December 28, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 28, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 30, 2020

Completed
Last Updated

November 4, 2022

Status Verified

November 1, 2022

Enrollment Period

3 months

First QC Date

December 28, 2020

Last Update Submit

November 1, 2022

Conditions

Keywords

periodontal diseaseperiodontitisgingivitiscytokines

Outcome Measures

Primary Outcomes (2)

  • Measurement of IL-1Beta level

    GCF was taken interproximal region.

    GCF was taken within 1 week after clinical examination

  • Measurement of IL-6 level in GCF

    GCF was taken interproximal region.

    GCF was taken within 1 week after clinical examination

Study Arms (3)

Healthy control groups

clinically healthy gingiva BOP score less than 10%

Diagnostic Test: gingival crevicular fluid

Gingivitis groups

BOP score of 10% or greater

Diagnostic Test: gingival crevicular fluid

Periodontitis groups

interdental AL ≥5 mm, PD≥6 mm

Diagnostic Test: gingival crevicular fluid

Interventions

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

Gingivitis groupsHealthy control groupsPeriodontitis groups

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

individuals who have periodontal disease will be selected

You may qualify if:

  • have periodontitis
  • have 16 permanent teeth

You may not qualify if:

  • Systemic disease
  • using drugs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Usak

Uşak, 64200, Turkey (Türkiye)

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Gingival crevicular fluid

MeSH Terms

Conditions

PeriodontitisPeriodontal DiseasesGingivitis

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic DiseasesInfectionsGingival Diseases

Study Officials

  • ahu dikilitaş

    University of Usak

    PRINCIPAL INVESTIGATOR
  • fatih karaaslan

    University of Usak

    STUDY CHAIR
  • abdullah seçkin ertuğrul

    University of IZMIR KATİP CELEBİ

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Usak University Faculty of Dentistry

Study Record Dates

First Submitted

December 28, 2020

First Posted

December 30, 2020

Study Start

October 8, 2020

Primary Completion

December 25, 2020

Study Completion

December 28, 2020

Last Updated

November 4, 2022

Record last verified: 2022-11

Locations