NCT06295666

Brief Summary

Objective: The aim of this study is to determine the amounts of BPI (Bactericidal permeability protein) and interleukin-1beta (IL-1β) in gingival fluid samples obtained from individuals with periodontally healthy and periodontal disease, to compare these amounts between study groups, and to evaluate their relationship with clinical parameters. In cases where clinical parameters increase, IL-1β amounts also increase significantly. The amount of IL-1β in individuals with periodontal disease is significantly higher compared to healthy individuals. There is positive correlation between BPI and clinical parameters. The amount of BPI in individuals with periodontal disease is significantly higher than in healthy individuals. More studies are needed to better understand the importance and therapeutic effect of BPI in periodontitis

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2019

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

February 19, 2019

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 25, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 20, 2020

Completed
4 years until next milestone

First Submitted

Initial submission to the registry

January 2, 2024

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 6, 2024

Completed
Last Updated

March 6, 2024

Status Verified

March 1, 2024

Enrollment Period

9 months

First QC Date

January 2, 2024

Last Update Submit

March 4, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Gingival Crevicular Fluid Bactericidal Permeability Increasing Protein levels in periodonitis

    Protein levels that increase gingival crevicular fluid bactericidal permeability are expected to increase in the periodontitis group.

    through study completion, an average of 1 year

Study Arms (2)

Healty

Periodontal healty group

Periodontitis

Periodontitis group

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who applied to Akdeniz University Faculty of Dentistry Department of Periodontology between 19/02/2019 and 25/11/2019 were included.

You may qualify if:

  • For the periodontitis group, intraoral examination shows inflammation in the gums, supragingival and by observing the formation of subgingival tartar and microbial dental plaque and pockets, Diagnosis of periodontitis means that there is a vertical or detection of horizontal bone loss (Periodontitis group),
  • Failure to observe the presence of periodontal pockets, vertical and horizontal no bone destruction, bleeding score on full-mouth probing below 10 percent (Healthy group),
  • Agreeing to participate in the research and filling out and signing the voluntary consent form.

You may not qualify if:

  • Pregnant and lactating individuals,
  • Individuals who smoke,
  • Individuals with any systemic disease,
  • Individuals who have received periodontal treatment in the last 6 months,
  • Individuals who have used antibiotics in the last 6 months
  • Individuals in whom local factors that increase destruction such as fillings and crowns are observed in areas with periodontal pocket formation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Akdeniz Üniversitesi Diş Hekimliği Fakültesi

Antalya, Turkey (Türkiye)

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Gingival Crevicular Fluid

MeSH Terms

Conditions

Periodontitis

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic Diseases

Study Design

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

Study Record Dates

First Submitted

January 2, 2024

First Posted

March 6, 2024

Study Start

February 19, 2019

Primary Completion

November 25, 2019

Study Completion

January 20, 2020

Last Updated

March 6, 2024

Record last verified: 2024-03

Locations