NCT04629313

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 gums that occurs in one or more areas without loss of attachments.1 in periodontitis, an inflammatory event that begins in the gum 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, MIP-1alfa and G-CSF 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, MIP-1alfa, G-CSF cytokines in the gum groove 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
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2020

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

November 9, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 16, 2020

Completed
Last Updated

October 5, 2021

Status Verified

September 1, 2021

Enrollment Period

4 months

First QC Date

November 9, 2020

Last Update Submit

September 27, 2021

Conditions

Keywords

periodontal diseaseperiodontitiscytokines

Outcome Measures

Primary Outcomes (1)

  • Measurement of IL-1Beta, G-CSF, MIP-1alfa levels in GCF

    Measurement of GCF samples

    GCF samples were collected in the morning hours 24-48 hours after clinical periodontal measurement. GCF was obtained using strips of filter paper† from the buccal part of an interproximal region.

Study Arms (2)

periodontal disease group

Gingivitis: BOP score of 10% or greater and PD≤3mm with no attachment or radiographic bone loss. SI Periodontitis: interdental AL of 1-2 mm, PD≤4 mm and no tooth loss SII Periodontitis: interdental AL of 3-4 mm, PD≤5 mm and no tooth loss SIII Periodontitis: interdental AL ≥5 mm, PD≥6 mm SIV Periodontitis: interdental AL ≥5 mm teeth, radiographic bone lose extending to middle or apical third of the root,

periodontal healthy group

consisted of individuals with clinically healthy gingiva

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:

  • Clinical diagnosis of periodontal diseases
  • Individuals must have 16 permanent teeth in their mouth

You may not qualify if:

  • Diabetes
  • İmmunological diseases

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 Diseases

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic Diseases

Study Officials

  • ahu dikilitaş

    University of Usak

    PRINCIPAL INVESTIGATOR
  • fatih karaaslan

    University of Usak

    STUDY CHAIR
  • umut yiğit

    University of Usak

    STUDY CHAIR
  • esra özge aydın

    University of Usak

    STUDY CHAIR
  • Abdullah seçkin ertuğrul

    University of Usak

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

November 9, 2020

First Posted

November 16, 2020

Study Start

July 1, 2020

Primary Completion

October 30, 2020

Study Completion

October 30, 2020

Last Updated

October 5, 2021

Record last verified: 2021-09

Locations