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Smoking and Peptidoglycan Recognition Protein-1 and Initial Periodontal Therapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03915730
Recruitment Status : Completed
First Posted : April 16, 2019
Last Update Posted : April 16, 2019
Sponsor:
Information provided by (Responsible Party):
Meltem Karsiyaka Hendek, Kırıkkale University

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.

Condition or disease Intervention/treatment Phase
Smoking, Cigarette Other: Initial periodontal therapy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of Smoking on Gingival Crevicular Fluid Peptidoglycan Recognition Protein-1 Level Following Initial Periodontal Therapy in Chronic Periodontitis
Actual Study Start Date : August 2016
Actual Primary Completion Date : July 2017
Actual Study Completion Date : November 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Smoking

Arm Intervention/treatment
Experimental: Smokers with chronic periodontitis
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.
Other: Initial periodontal therapy
Scaling and root planing and polishing with specific curettes were performed to patients with CP and oral hygiene education was provided to each patient.

Experimental: Non-smokers with chronic periodontitis
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
Other: Initial periodontal therapy
Scaling and root planing and polishing with specific curettes were performed to patients with CP and oral hygiene education was provided to each patient.

No Intervention: Smokers with periodontal healthy
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.
No Intervention: Non-smokers with periodontal healthy
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



Primary Outcome Measures :
  1. Change in peptidoglycan recognition protein-1 [ Time Frame: Baseline and 3 months ]
    Total amount of Peptidoglycan Recognition Protein-1 (µg) in gingival crevicular fluid


Secondary Outcome Measures :
  1. Change in periodontal clinical parameter [ Time Frame: Baseline and 3 months ]
    Clinical attachment level (mm) (from cemento-enamel junction to the base of periodontal pocket)



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Ages Eligible for Study:   22 Years to 56 Years   (Adult)
Accepts Healthy Volunteers:   Yes
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.
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Responsible Party: Meltem Karsiyaka Hendek, Assistant Professor, Kırıkkale University
ClinicalTrials.gov Identifier: NCT03915730    
Other Study ID Numbers: 2016/026
First Posted: April 16, 2019    Key Record Dates
Last Update Posted: April 16, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Meltem Karsiyaka Hendek, Kırıkkale University:
Chronic periodontitis
gingival crevicular fluid
initial periodontal therapy
peptidoglycan recognition proteins
smoking
Additional relevant MeSH terms:
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Chronic Periodontitis
Periodontitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases