Effects of Smoking on Non-surgical Periodontal Therapy in Generalized Aggressive Periodontitis
Primary Purpose
Generalized Aggressive Periodontitis, Smoking
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Non-surgical periodontal therapy
Sponsored by
About this trial
This is an interventional treatment trial for Generalized Aggressive Periodontitis focused on measuring Generalized aggressive periodontitis, Non-surgical periodontal therapy, Periodontopathogens, Smoking, Gingival crevicular fluid
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Non-smoker Group
Smoker Group
Arm Description
This group included non-smoker generalized aggressive periodontitis patients.
This group included smoker generalized aggressive periodontitis patients.
Outcomes
Primary Outcome Measures
Change in Clinical Attachment Level (CAL)
Secondary Outcome Measures
Change in Probing Depth (PD)
Change in Bleeding on Probing (BoP)
Change in Plaque Index (PI)
Changing of the salivary biomarkers
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).
Changing of the serum biomarkers
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).
Changing of the gingival crevicular fluid (GCF) biomarkers
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).
Changing of the amount of pathogen microorganisms
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.
Full Information
NCT ID
NCT03512938
First Posted
March 24, 2018
Last Updated
April 27, 2018
Sponsor
Ege University
Collaborators
University of Glasgow
1. Study Identification
Unique Protocol Identification Number
NCT03512938
Brief Title
Effects of Smoking on Non-surgical Periodontal Therapy in Generalized Aggressive Periodontitis
Official Title
Effects of Smoking on Non-surgical Periodontal Therapy in Generalized Aggressive Periodontitis
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
June 23, 2014 (Actual)
Primary Completion Date
February 8, 2016 (Actual)
Study Completion Date
September 28, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ege University
Collaborators
University of Glasgow
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Generalized Aggressive Periodontitis, Smoking
Keywords
Generalized aggressive periodontitis, Non-surgical periodontal therapy, Periodontopathogens, Smoking, Gingival crevicular fluid
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
27 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Non-smoker Group
Arm Type
Active Comparator
Arm Description
This group included non-smoker generalized aggressive periodontitis patients.
Arm Title
Smoker Group
Arm Type
Experimental
Arm Description
This group included smoker generalized aggressive periodontitis patients.
Intervention Type
Procedure
Intervention Name(s)
Non-surgical periodontal therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Clinical Attachment Level (CAL)
Time Frame
Baseline and 1 month, 3 month, 6 month after non-surgical periodontal therapy
Secondary Outcome Measure Information:
Title
Change in Probing Depth (PD)
Time Frame
Baseline and 1 month, 3 month, 6 month after non-surgical periodontal therapy
Title
Change in Bleeding on Probing (BoP)
Time Frame
Baseline and 1 month, 3 month, 6 month after non-surgical periodontal therapy
Title
Change in Plaque Index (PI)
Time Frame
Baseline and 1 month, 3 month, 6 month after non-surgical periodontal therapy
Title
Changing of the salivary biomarkers
Description
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).
Time Frame
Baseline and 1 month, 3 month, 6 month after non-surgical periodontal therapy
Title
Changing of the serum biomarkers
Description
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).
Time Frame
Baseline and 1 month, 3 month, 6 month after non-surgical periodontal therapy
Title
Changing of the gingival crevicular fluid (GCF) biomarkers
Description
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).
Time Frame
Baseline and 1 month, 3 month, 6 month after non-surgical periodontal therapy
Title
Changing of the amount of pathogen microorganisms
Description
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.
Time Frame
Baseline and 1 month, 3 month, 6 month after non-surgical periodontal therapy
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
12. IPD Sharing Statement
Learn more about this trial
Effects of Smoking on Non-surgical Periodontal Therapy in Generalized Aggressive Periodontitis
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