- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03512938
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
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
27
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
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 |
Intervention / Treatment |
---|---|
Active Comparator: Non-smoker Group
This group included non-smoker generalized aggressive periodontitis patients.
|
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.
|
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
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
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
Collaborators
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)
June 23, 2014
Primary Completion (Actual)
February 8, 2016
Study Completion (Actual)
September 28, 2017
Study Registration Dates
First Submitted
March 24, 2018
First Submitted That Met QC Criteria
April 27, 2018
First Posted (Actual)
May 1, 2018
Study Record Updates
Last Update Posted (Actual)
May 1, 2018
Last Update Submitted That Met QC Criteria
April 27, 2018
Last Verified
April 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID 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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