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Completed

NCT Number: NCT06295666

Gingival Crevicular Fluid (GCF) Bactericidal Permeability Protein (BPI) and Interleukin (IL)-1 Beta

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

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Akdeniz Üniversitesi Diş Hekimliği Fakültesi

Antalya, Turkey (Türkiye)

About this study

Systemically healthy and non-smoking participants were included in the study. The study groups included a total of 100 participants, 50 of whom were periodontally healthy (healthy group) and 50 with periodontal disease (periodontitis) group). The clinical parameters of plaque index (PI), gingival index (GI), and pocket depth (PD), clinical attachment level (CAL), and bleeding on probing (BOP) were measured.

The gingival fluid samples were taken in the direction of the paper strip and ELISA method was used for their analysis. A positive, statistically significant relationship was found between IL-1β levels and all clinical parameters (PI, GI, PD, CAL, BOP) (p<0,01). Likewise, there is a positive and significant relationship between BPI levels and clinical parameters (p<0,01).

There is a statistically significant positive correlation between GCF volume and clinical parameters PI (r: 0,722), GI (r: 0,740), PD (r: 0,742), CAL (r: 0,751) and BOP (r: 0.752) (p < 0.01). In the comparison between the groups, it is seen that both IL-1β and BPI levels were statistically significantly higher in the periodontitis group compared to the healthy group (p < 0,001).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Primary outcomes

  1. Gingival Crevicular Fluid Bactericidal Permeability Increasing Protein levels in periodonitis

    Time frame: through study completion, an average of 1 year

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

Sponsors and collaborators

Lead sponsor

Akdeniz University

Other

Registry information

Official study title

Gingival Crevicular Fluid(GCF) Bactericidal Permeability Protein (BPI) and Interleukin(IL)-1 Beta Levels and Relationship With Periodontal Disease

Important dates

Study start
2019
Primary completion
2019
Study completion
2020
First posted
Mar 6, 2024
Registry last updated
Mar 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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