Bactericidal Permeability Protein Inhibitor and Interleukin-1beta Levels After Non-surgical Periodontal Treatment

April 3, 2024 updated by: Nezahat Arzu Kayar, Akdeniz University

Gingival Crevicular Fluid (GCF) Bactericidal/Permeability-increasing Protein (BPI) and Interleukin (IL)-1beta in Periodontitis Patients: Non-surgical Periodontal Treatment Effects

The aim of this study was to examine the relationship between healing response after non-surgical periodontal treatment and baseline gingival crevicular fluid (GCF) levels of bactericidal/permeability-increasing protein (BPI) and interleukin-1beta (IL-1ß).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Bactericidal/permeability-increasing proteins (BPI) specific and powerful effect against Gram negative bacteria and their LPSs is completely observable in biological fluids such as plasma, serum, and whole blood.

Objective: It is the evaluation of periodontal disease effect of BPI and interleukin-1 beta (IL-1 β) levels in gingival fluid before and after non-surgical periodontal treatment (NSPT)in patients with periodontal disease.

Method: Thirty systemically healthy and non-smoking individuals with periodontitis were included in the study. Before NSPT, the clinical parameters of plaque index (PI), gingival index (GI), probing depth (PD), clinical attachment level (CAS), bleeding on probing (BOP) were measured. The gingival fluid samples were taken using the paper strip method. The same procedures were repeated at 6 weeks and 6 months after non-surgical periodontal treatment. ELISA method was used for the analysis of the samples

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Antalya, Turkey, 07070
        • Akdeniz University
      • Antalya, Turkey
        • Akdeniz Üniversitesi Diş Hekimliği Fakültesi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria

Systemically healthy,

  • Stage II or III, Grade A periodontitis
  • Having at least 20 permanent teeth (excluding third molars and any tooth loss induced by -non-periodontal causes).

Exclusion Criteria:

Smoking,

  • use of alcohol; pregnancy or lactation; intake ofantibiotics, steroidal or non-steroidal anti-inflammatory drugs within the last 6 months
  • having received periodontal treatment within the last 6 months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Healty
Non-surgical periodontal treatment
Procedure: Non-surgical periodontal treatment
Scaling and root planing in two sessions over the course of a 48-hour period comprised the standard treatment procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gingival crevicular fluid Bactericidal/permeability-increasing proteins levels
Time Frame: through study completion, an average of 1 year
Gingival Crevicular Fluid Bactericidal Permeability Increasing Protein levels in periodonitis patients after Non-surgical periodontal treatment
through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gingival crevicular fluid interleukin-1Beta levels
Time Frame: through study completion, an average of 1 year
Gingival Crevicular Fluid IL-1β in periodonitis patients after Non-surgical periodontal treatment
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Akdeniz University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 19, 2019

Primary Completion (Actual)

September 20, 2020

Study Completion (Actual)

September 20, 2020

Study Registration Dates

First Submitted

March 7, 2024

First Submitted That Met QC Criteria

April 3, 2024

First Posted (Actual)

April 9, 2024

Study Record Updates

Last Update Posted (Actual)

April 9, 2024

Last Update Submitted That Met QC Criteria

April 3, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20.02.2019/177

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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