The Impact of Cigarette Smoking on Periodontal Therapy
Primary Purpose
Periodontitis, Cigarette Smoking
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Non-surgical periodontal therapy: motivation and instruction in oral hygiene, debridement using handinstrumentation (Hu-Firedy,Chicago, IL, USA;and American Eagle Instruments,Missoula, MT,USA).
Sponsored by

About this trial
This is an interventional treatment trial for Periodontitis
Eligibility Criteria
Inclusion Criteria:
- healthy subjects
- age 35-75 years
- diagnosed with chronic periodontitis
- at least four non-adjacent teeth with proximal sites with a PD ≥6 mm and clinical attachment loss ≥5 mm with BoP and no radiographic signs of apical pathology.
- either smokers (>10 cigarettes per day for at least 5 years) or non-smokers (never smoked or not within the last 5 years).
Exclusion Criteria:
- subjects who presented with any current medical condition or used medications known to affect periodontal healing
- incorrectly reported smoking status
- use of antibiotics within 6 months of the study
- received subgingival scaling within 6 months of the study
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Cigarette smokers with periodontitis
Non-smokers with periodontitis
Arm Description
Periodontal therapy in cigarette smokers
Periodontal therapy in non-smokers
Outcomes
Primary Outcome Measures
PD ≥5 mm with BoP
Corrected for clustering within patients, teeth, and sites over time, was the unit of the analysis and PD ≥5 mm with BoP was the outcome (dependent variable) dichotomized as present (1) or absent (0).
Secondary Outcome Measures
Teeth present
Number of teeth
Clinical periodontal attachmentloss
Clinical attachment loss in mm
Periodontal pocket depth
Probing depth in mm
Bleeding at site level
Bleeding on probing (yes or no)
Bleeding at patient level
Bleeding index in percentage (%)
Plaque at patient level
Plaque index in percentage (%)
Amount of periopathogenic bacteria
Subgingival plaque samples of 20 subgingival periopathogenic bacterial species were analysed using checkerboard DNA-DNA hybridization.
Inflammatory gingival crevicular fluid markers (proteins)
Concentrations of gingival crevicular fluid biomarkers measured in pg/mLwere analysed using multiplex and singleplex micro-bed immunoassays.
Serum proteins
Concentration of inflammatory serum markers measured in pg/ɥL determined using multiplex kit Bio-Plex Human ProTM Assay.
Gene expression in blood
Inflammatory gene (RNA) expression levels is estimated by counting the reads that map to genes or exones using the the RPKM (Reads per Kilobases per Million reads) methods.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05120206
Brief Title
The Impact of Cigarette Smoking on Periodontal Therapy
Official Title
Outcomes of Periodontal Therapy in Smokers and Non-smokers With Chronic Periodontitis
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
April 1, 2012 (Actual)
Primary Completion Date
March 1, 2015 (Actual)
Study Completion Date
March 1, 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Bergen
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Periodontitis patients, 40 cigarette smokers and 40 non-smokers (defined by cotinine measures in serum), were recruited to this double arm prospective cohort study. Data were collected 3 months following non-surgical and surgical periodontal treatment, and following 12 months with supportive periodontal therapy. Data collected were clinical attachment level, probing depth, bleeding on probing,oral bacteria, serum, blood (PAXgeneBlood), and gingival crevicular fluid.
Detailed Description
The overall aim of this work was to study clinical outcomes of active and supportive periodontal therapy in smokers and non-smokers with chronic periodontitis at patient, tooth, and site level. Moreover, to compare the periopathogenic microflora and inflammatory markers in gingival crevicular fluid and in blood in smokers and non-smokers following therapy.
Eighty patients, 40 smokers and 40 non-smokers, with moderate to severe chronic periodontitis were included in this prospective cohort study and treated non-surgically and surgically, and then followed-up in a supportive periodontal therapy program for 12 months. Smoking status was validated measuring serum cotinine levels at pre-treatment and 12 months following supportive periodontal therapy.
Clinical measurements included full mouth recordings of clinical attachment level, probing depth, bleeding on probing, and plaque index at pre-treatment and following active and supportive periodontal therapy. At the same timepoints, subgingival plaque samples of 20 subgingival periopathogenic bacterial species were analysed using checkerboard DNA-DNA hybridization. Blood samples (PAXgeneBlood), serum, gingval crevicular fluid were also collected at the three timepoints.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontitis, Cigarette Smoking
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective cohort study
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cigarette smokers with periodontitis
Arm Type
Active Comparator
Arm Description
Periodontal therapy in cigarette smokers
Arm Title
Non-smokers with periodontitis
Arm Type
Active Comparator
Arm Description
Periodontal therapy in non-smokers
Intervention Type
Procedure
Intervention Name(s)
Non-surgical periodontal therapy: motivation and instruction in oral hygiene, debridement using handinstrumentation (Hu-Firedy,Chicago, IL, USA;and American Eagle Instruments,Missoula, MT,USA).
Other Intervention Name(s)
Periodontal surgery: periodontal flap and gingivectomy with postoperative rinse with 0.2% chlorhexidine gluconate (Corsodyl, GlaxoSmithKline, London, UK).
Intervention Description
Non-surgical and surgical periodontal therapy in cigarette smokers and non-smokers
Primary Outcome Measure Information:
Title
PD ≥5 mm with BoP
Description
Corrected for clustering within patients, teeth, and sites over time, was the unit of the analysis and PD ≥5 mm with BoP was the outcome (dependent variable) dichotomized as present (1) or absent (0).
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Teeth present
Description
Number of teeth
Time Frame
24 months
Title
Clinical periodontal attachmentloss
Description
Clinical attachment loss in mm
Time Frame
24 months
Title
Periodontal pocket depth
Description
Probing depth in mm
Time Frame
24 months
Title
Bleeding at site level
Description
Bleeding on probing (yes or no)
Time Frame
24 months
Title
Bleeding at patient level
Description
Bleeding index in percentage (%)
Time Frame
24 months
Title
Plaque at patient level
Description
Plaque index in percentage (%)
Time Frame
24 months
Title
Amount of periopathogenic bacteria
Description
Subgingival plaque samples of 20 subgingival periopathogenic bacterial species were analysed using checkerboard DNA-DNA hybridization.
Time Frame
24 months
Title
Inflammatory gingival crevicular fluid markers (proteins)
Description
Concentrations of gingival crevicular fluid biomarkers measured in pg/mLwere analysed using multiplex and singleplex micro-bed immunoassays.
Time Frame
24 months
Title
Serum proteins
Description
Concentration of inflammatory serum markers measured in pg/ɥL determined using multiplex kit Bio-Plex Human ProTM Assay.
Time Frame
24 months
Title
Gene expression in blood
Description
Inflammatory gene (RNA) expression levels is estimated by counting the reads that map to genes or exones using the the RPKM (Reads per Kilobases per Million reads) methods.
Time Frame
24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
healthy subjects
age 35-75 years
diagnosed with chronic periodontitis
at least four non-adjacent teeth with proximal sites with a PD ≥6 mm and clinical attachment loss ≥5 mm with BoP and no radiographic signs of apical pathology.
either smokers (>10 cigarettes per day for at least 5 years) or non-smokers (never smoked or not within the last 5 years).
Exclusion Criteria:
subjects who presented with any current medical condition or used medications known to affect periodontal healing
incorrectly reported smoking status
use of antibiotics within 6 months of the study
received subgingival scaling within 6 months of the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dagmar F. Bunæs, PhD
Organizational Affiliation
Department of Clinical Dentistry - periodontics, University of Bergen, Norway
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
26407817
Citation
Bunaes DF, Lie SA, Enersen M, Aastrom AN, Mustafa K, Leknes KN. Site-specific treatment outcome in smokers following non-surgical and surgical periodontal therapy. J Clin Periodontol. 2015 Oct;42(10):933-42. doi: 10.1111/jcpe.12462. Epub 2015 Oct 28.
Results Reference
result
PubMed Identifier
28306142
Citation
Bunaes DF, Mustafa M, Mohamed HG, Lie SA, Leknes KN. The effect of smoking on inflammatory and bone remodeling markers in gingival crevicular fluid and subgingival microbiota following periodontal therapy. J Periodontal Res. 2017 Aug;52(4):713-724. doi: 10.1111/jre.12438. Epub 2017 Mar 17.
Results Reference
result
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The Impact of Cigarette Smoking on Periodontal Therapy
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