- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03915730
Smoking and Peptidoglycan Recognition Protein-1 and Initial Periodontal Therapy
April 14, 2019 updated by: Meltem Karsiyaka Hendek, Kırıkkale University
The Effect of Smoking on Gingival Crevicular Fluid Peptidoglycan Recognition Protein-1 Level Following Initial Periodontal Therapy in Chronic Periodontitis
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
80
Phase
- Not Applicable
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
22 years to 56 years (ADULT)
Accepts Healthy Volunteers
Yes
Description
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.
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: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / 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.
|
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
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in peptidoglycan recognition protein-1
Time Frame: Baseline and 3 months
|
Total amount of Peptidoglycan Recognition Protein-1 (µg) in gingival crevicular fluid
|
Baseline and 3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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)
|
Baseline and 3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
August 1, 2016
Primary Completion (ACTUAL)
July 1, 2017
Study Completion (ACTUAL)
November 1, 2017
Study Registration Dates
First Submitted
April 11, 2019
First Submitted That Met QC Criteria
April 14, 2019
First Posted (ACTUAL)
April 16, 2019
Study Record Updates
Last Update Posted (ACTUAL)
April 16, 2019
Last Update Submitted That Met QC Criteria
April 14, 2019
Last Verified
April 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2016/026
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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