Effects of Smoking on Non-surgical Periodontal Therapy in Generalized Aggressive Periodontitis

April 27, 2018 updated by: Nurcan Buduneli, Ege University
Smoking is the major preventable risk factor in the initiation and progression of periodontal diseases. Periodontitis risk was found to be 3.9 times higher among smokers aged between 19-30 years and 2.8 times higher among smokers aged 31-40 years compared to non-smokers. Aggressive periodontitis (AgP), is characterized by a rapid attachment loss usually incompatible with the amount of plaque and dental calculus. It is often not possible to predict the prognosis of treatment with various treatment options in cases of aggressive periodontitis. It was hypothesized that non-smoker patients with generalized aggressive periodontitis (GAgP) will respond better to conventional mechanical non-surgical periodontal therapy compared to the smokers. Therefore, the aim of this study was to evaluate the effects of smoking on the outcomes of non-surgical periodontal treatment in terms of the clinical, biochemical and microbiological parameters.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
27

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Having at least six permanent teeth, including incisors and/or first molars with severe periodontal disease
  • Having at least one site with probing depth (PD) and clinical attachment level (CAL) ≥5 mm and six teeth other than first molars and incisors with similar PD and CAL measurements
  • Familial aggregation

Exclusion Criteria:

  • Medical disorders such as diabetes mellitus, immunological disorders
  • Having an antibiotic or periodontal treatment in the last 6 months
  • Having <15 teeth

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: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Non-smoker Group
This group included non-smoker generalized aggressive periodontitis patients.
Procedure: Non-surgical periodontal therapy
Patients were motivated and instructed to brush with modified Bass technique and use interdental toothbrushes, dental floss. Each patient underwent quadrant scaling and root planning (SRP) under local anaesthesia over a 4-week period. Root planing (RP) was performed under local anaesthesia (2% lidocaine, epinephrine 1:100.000) and a standard curette set newly sharpened with Arkansas stone was used for each patient.
Experimental: Smoker Group
This group included smoker generalized aggressive periodontitis patients.
Procedure: Non-surgical periodontal therapy
Patients were motivated and instructed to brush with modified Bass technique and use interdental toothbrushes, dental floss. Each patient underwent quadrant scaling and root planning (SRP) under local anaesthesia over a 4-week period. Root planing (RP) was performed under local anaesthesia (2% lidocaine, epinephrine 1:100.000) and a standard curette set newly sharpened with Arkansas stone was used for each patient.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Change in Clinical Attachment Level (CAL)
Time Frame: Baseline and 1 month, 3 month, 6 month after non-surgical periodontal therapy
Baseline and 1 month, 3 month, 6 month after non-surgical periodontal therapy

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Probing Depth (PD)
Time Frame: Baseline and 1 month, 3 month, 6 month after non-surgical periodontal therapy
Baseline and 1 month, 3 month, 6 month after non-surgical periodontal therapy
Change in Bleeding on Probing (BoP)
Time Frame: Baseline and 1 month, 3 month, 6 month after non-surgical periodontal therapy
Baseline and 1 month, 3 month, 6 month after non-surgical periodontal therapy
Change in Plaque Index (PI)
Time Frame: Baseline and 1 month, 3 month, 6 month after non-surgical periodontal therapy
Baseline and 1 month, 3 month, 6 month after non-surgical periodontal therapy
Changing of the salivary biomarkers
Time Frame: Baseline and 1 month, 3 month, 6 month after non-surgical periodontal therapy
In the morning following an overnight fast, during which subjects were requested not to drink (except water) or to chew gum, whole saliva samples were obtained by expectorating into polypropylene tubes; clinical periodontal measurements and any necessary periodontal interventions were then carried out. Cytokine levels were assessed by Enzyme-linked immunosorbent assay (ELISA).
Baseline and 1 month, 3 month, 6 month after non-surgical periodontal therapy
Changing of the serum biomarkers
Time Frame: Baseline and 1 month, 3 month, 6 month after non-surgical periodontal therapy
Nine milliliters of venous blood were taken from the antecubital vein by a standard venipuncture method and centrifuged for 10 minutes at 3,000 rpm, separating serum from the cells. Cytokine levels were assessed by Enzyme-linked immunosorbent assay (ELISA).
Baseline and 1 month, 3 month, 6 month after non-surgical periodontal therapy
Changing of the gingival crevicular fluid (GCF) biomarkers
Time Frame: Baseline and 1 month, 3 month, 6 month after non-surgical periodontal therapy
GCF samples were obtained from buccal aspects of one interproximal site in each quadrant. Supragingival plaque was removed carefully by sterile curettes; the surfaces were dried and isolated by cotton rolls. Filter paper strips were placed in the orifices of the gingival sulcus/pocket for 30 seconds. Care was used to avoid mechanical trauma, and strips contaminated with blood were discarded. The absorbed GCF volume was estimated by a calibrated instrument. The readings of GCF sample volumes were converted to an actual volume (μL) by reference to the standard curve. Cytokine levels were assessed by Enzyme-linked immunosorbent assay (ELISA).
Baseline and 1 month, 3 month, 6 month after non-surgical periodontal therapy
Changing of the amount of pathogen microorganisms
Time Frame: Baseline and 1 month, 3 month, 6 month after non-surgical periodontal therapy
Plaque samples were collected from the same sites by sterile paper points from the base of the pockets. Paper points were inserted into the deepest part of the pocket and kept for 5 seconds. Paper points were then placed into propylene tubes. Real-time polymerase chain reaction was used for detection and quantification of bacterial cell copy numbers in 1 mg plaque.
Baseline and 1 month, 3 month, 6 month after non-surgical periodontal therapy

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ege University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Glasgow

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 23, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 8, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 28, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 24, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 27, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 1, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 1, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 27, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2014-DIS-013

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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