The Impact of Cigarette Smoking on Periodontal Therapy

Study Overview
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Brief Summary
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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
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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.

Official Title
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Outcomes of Periodontal Therapy in Smokers and Non-smokers With Chronic Periodontitis

Conditions
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Periodontitis, Cigarette Smoking

Intervention / Treatment
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* Procedure: 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).


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective cohort study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Cigarette smokers with periodontitis<br>Periodontal therapy in cigarette smokers | Procedure: 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).<br>* Non-surgical and surgical periodontal therapy in cigarette smokers and non-smokers<br>* Other names: Periodontal surgery: periodontal flap and gingivectomy with postoperative rinse with 0.2% chlorhexidine gluconate (Corsodyl, GlaxoSmithKline, London, UK).;|
| Active Comparator: Non-smokers with periodontitis<br>Periodontal therapy in non-smokers | Procedure: 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).<br>* Non-surgical and surgical periodontal therapy in cigarette smokers and non-smokers<br>* Other names: Periodontal surgery: periodontal flap and gingivectomy with postoperative rinse with 0.2% chlorhexidine gluconate (Corsodyl, GlaxoSmithKline, London, UK).;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Teeth present | Number of teeth | 24 months | 
| Clinical periodontal attachmentloss | Clinical attachment loss in mm | 24 months | 
| Periodontal pocket depth | Probing depth in mm | 24 months | 
| Bleeding at site level | Bleeding on probing (yes or no) | 24 months | 
| Bleeding at patient level | Bleeding index in percentage (%) | 24 months | 
| Plaque at patient level | Plaque index in percentage (%) | 24 months | 
| Amount of periopathogenic bacteria | Subgingival plaque samples of 20 subgingival periopathogenic bacterial species were analysed using checkerboard DNA-DNA hybridization. | 24 months | 
| Inflammatory gingival crevicular fluid markers (proteins) | Concentrations of gingival crevicular fluid biomarkers measured in pg/mLwere analysed using multiplex and singleplex micro-bed immunoassays. | 24 months | 
| Serum proteins | Concentration of inflammatory serum markers measured in pg/ɥL determined using multiplex kit Bio-Plex Human ProTM Assay. | 24 months | 
| 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. | 24 months |