- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06295666
Gingival Crevicular Fluid (GCF) Bactericidal Permeability Protein (BPI) and Interleukin (IL)-1 Beta
Gingival Crevicular Fluid(GCF) Bactericidal Permeability Protein (BPI) and Interleukin(IL)-1 Beta Levels and Relationship With Periodontal Disease
Study Overview
Status
Detailed Description
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).
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Antalya, Turkey
- Akdeniz Üniversitesi Diş Hekimliği Fakültesi
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
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Healty
Periodontal healty group
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Periodontitis
Periodontitis group
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Gingival Crevicular Fluid Bactericidal Permeability Increasing Protein levels in periodonitis
Time Frame: through study completion, an average of 1 year
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Protein levels that increase gingival crevicular fluid bactericidal permeability are expected to increase in the periodontitis group.
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through study completion, an average of 1 year
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 26.12.2018/901
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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