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Smoking and Peptidoglycan Recognition Protein-1 and Initial Periodontal Therapy

Primary Purpose

Smoking, Cigarette

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Initial periodontal therapy
Sponsored by
Kırıkkale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Smoking, Cigarette focused on measuring Chronic periodontitis, gingival crevicular fluid, initial periodontal therapy, peptidoglycan recognition proteins, smoking

Eligibility Criteria

22 Years - 56 Years (Adult)Accepts Healthy Volunteers

Inclusion Criteria:

  • Clinical diagnosis of severe chronic periodontitis
  • Clinical diagnosis of periodontal health

Exclusion Criteria:

  • have any systemic disease,
  • to be alcohol consumer,
  • to receive any periodontal therapy in the past 6 months,
  • to take any drugs regularly
  • to be pregnant and/or lactate.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    Experimental

    No Intervention

    No Intervention

    Arm Label

    Smokers with chronic periodontitis

    Non-smokers with chronic periodontitis

    Smokers with periodontal healthy

    Non-smokers with periodontal healthy

    Arm Description

    Patients who had teeth with 30% periodontal bone loss, presence of at least two nonadjacent sites per quadrant with probing pocket depths of ≥5 mm, and bleeding on probing were assigned as chronic periodontitis group Patients who have smoked for at least 10 years and a minimum of 10 cigarettes per day were assigned as current smokers.

    Patients who had teeth with 30% periodontal bone loss, presence of at least two nonadjacent sites per quadrant with probing pocket depths of ≥5 mm, and bleeding on probing were assigned as chronic periodontitis group Never smoked patients were included into the nonsmoker group

    Individuals were diagnosed periodontally healthy as without attachment loss, periodontal disease history, whole mouth bleeding scores of <10% and a probing depth of ≤3 mm Patients who have smoked for at least 10 years and a minimum of 10 cigarettes per day were assigned as current smokers.

    Individuals were diagnosed periodontally healthy as without attachment loss, periodontal disease history, whole mouth bleeding scores of <10% and a probing depth of ≤3 mm Never smoked patients were included into the nonsmoker group

    Outcomes

    Primary Outcome Measures

    Change in peptidoglycan recognition protein-1
    Total amount of Peptidoglycan Recognition Protein-1 (µg) in gingival crevicular fluid

    Secondary Outcome Measures

    Change in periodontal clinical parameter
    Clinical attachment level (mm) (from cemento-enamel junction to the base of periodontal pocket)

    Full Information

    First Posted
    April 11, 2019
    Last Updated
    April 14, 2019
    Sponsor
    Kırıkkale University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03915730
    Brief Title
    Smoking and Peptidoglycan Recognition Protein-1 and Initial Periodontal Therapy
    Official Title
    The Effect of Smoking on Gingival Crevicular Fluid Peptidoglycan Recognition Protein-1 Level Following Initial Periodontal Therapy in Chronic Periodontitis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    August 2016 (Actual)
    Primary Completion Date
    July 2017 (Actual)
    Study Completion Date
    November 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Kırıkkale University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    A total of 40 patients with CP (20 smokers (S+CP) and 20 nonsmokers (S-CP)) and 40 periodontally healthy subjects (20 smokers (S+PH) and 20 nonsmokers (S-PH)), comprising 80 subjects, were included in this study. Baseline GCF samples were obtained from all subjects and clinical periodontal measurements, including probing depth (PD), clinical attachment level (CAL), plaque index (PI), and gingival index (GI), were recorded. In patients who had received initial periodontal therapy, GCF samples were obtained and all clinical periodontal measurements were recorded again during the 6th-8th weeks. GCF PGRP-1 levels were analyzed by enzyme-linked immunosorbent assay.
    Detailed Description
    Peptidoglycan recognition proteins (PGRPs) are one of the antimicrobial peptides that play a role in innate immunity and act against the bacterial cell wall. Smoking is the most important environmental risk factor for periodontitis. This study determined the effect of smoking on PGRP-1 levels in gingival crevicular fluid (GCF) in smokers and nonsmokers with chronic periodontitis (CP) following initial periodontal therapy.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Smoking, Cigarette
    Keywords
    Chronic periodontitis, gingival crevicular fluid, initial periodontal therapy, peptidoglycan recognition proteins, smoking

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    80 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Smokers with chronic periodontitis
    Arm Type
    Experimental
    Arm Description
    Patients who had teeth with 30% periodontal bone loss, presence of at least two nonadjacent sites per quadrant with probing pocket depths of ≥5 mm, and bleeding on probing were assigned as chronic periodontitis group Patients who have smoked for at least 10 years and a minimum of 10 cigarettes per day were assigned as current smokers.
    Arm Title
    Non-smokers with chronic periodontitis
    Arm Type
    Experimental
    Arm Description
    Patients who had teeth with 30% periodontal bone loss, presence of at least two nonadjacent sites per quadrant with probing pocket depths of ≥5 mm, and bleeding on probing were assigned as chronic periodontitis group Never smoked patients were included into the nonsmoker group
    Arm Title
    Smokers with periodontal healthy
    Arm Type
    No Intervention
    Arm Description
    Individuals were diagnosed periodontally healthy as without attachment loss, periodontal disease history, whole mouth bleeding scores of <10% and a probing depth of ≤3 mm Patients who have smoked for at least 10 years and a minimum of 10 cigarettes per day were assigned as current smokers.
    Arm Title
    Non-smokers with periodontal healthy
    Arm Type
    No Intervention
    Arm Description
    Individuals were diagnosed periodontally healthy as without attachment loss, periodontal disease history, whole mouth bleeding scores of <10% and a probing depth of ≤3 mm Never smoked patients were included into the nonsmoker group
    Intervention Type
    Other
    Intervention Name(s)
    Initial periodontal therapy
    Intervention Description
    Scaling and root planing and polishing with specific curettes were performed to patients with CP and oral hygiene education was provided to each patient.
    Primary Outcome Measure Information:
    Title
    Change in peptidoglycan recognition protein-1
    Description
    Total amount of Peptidoglycan Recognition Protein-1 (µg) in gingival crevicular fluid
    Time Frame
    Baseline and 3 months
    Secondary Outcome Measure Information:
    Title
    Change in periodontal clinical parameter
    Description
    Clinical attachment level (mm) (from cemento-enamel junction to the base of periodontal pocket)
    Time Frame
    Baseline and 3 months

    10. Eligibility

    Minimum Age & Unit of Time
    22 Years
    Maximum Age & Unit of Time
    56 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Clinical diagnosis of severe chronic periodontitis Clinical diagnosis of periodontal health Exclusion Criteria: have any systemic disease, to be alcohol consumer, to receive any periodontal therapy in the past 6 months, to take any drugs regularly to be pregnant and/or lactate.

    12. IPD Sharing Statement

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    Smoking and Peptidoglycan Recognition Protein-1 and Initial Periodontal Therapy

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