Effect of Smoking Cessation on Clinical and Microbiological Outcomes of the Non-surgical Periodontal Therapy

Study Overview
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Brief Summary
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The aim of this prospective interventional study is to verify the efficacy of smoking cessation on clinical and microbiological outcomes of non-surgical periodontal therapy of chronic periodontitis patients. Smokers willing to quit received periodontal treatment and concurrent smoking cessation therapy. Periodontal maintenance was performed every 3 months. A single calibrated examiner, blinded to smoking status, assessed periodontal clinical outcomes and applied a structured questionnaire in order to collect demographic and behavioural information. Further, expired carbon monoxide concentration were measured with a monoximeter. A pooled subgingival plaque sample was collected from the deepest periodontal pocket from each participant. The presence and quantification of Aggregatibacter actinomycetemcomitans, Porphyromonas gingivalis, Tannerella forsythia and Treponema denticola were determined using (RT-PCR).

Detailed Description
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Smokers willing to quit, with 10 teeth or more, and with periodontitis (30% or more of their teeth with proximal attachment loss ≥ 5 mm) were enrolled in the study. All subjects received periodontal treatment and concurrent smoking cessation therapy. Smoking cessation therapy was performed by a team comprising physicians, nurses, a psychologist and dentists, and consisted of four 1-h counselling lectures, psychologist-assisted cognitive behavioral therapy, nicotine replacement therapy and medication (bupropion or varenicline). Smoking cessation motivation was reinforced by dentists at the maintenance sessions, by means of motivational interviewing techniques. Periodontal therapy consisted in full-mouth supra and subgingival scaling and root planing (with curettes and ultrasonic scaler); oral hygiene instruction and motivation and removal of intra-oral plaque retentive factors. Further, periodontal maintenance was performed every 3 months. A single calibrated examiner, blinded to smoking status, assessed periodontal clinical outcomes (recession, pocket depth, clinical attachment level, plaque index and bleeding on probing). A structured questionnaire was applied in order to collect demographic and behavioral information. Expired carbon monoxide concentration was measured with a monoximeter, in order to validate smoking status. A pooled subgingival plaque sample was collected from the deepest periodontal pocket from each participant. The presence and quantification of Aggregatibacter actinomycetemcomitans, Porphyromonas gingivalis, Tannerella forsythia and Treponema denticola were determined using real time - PCR (RT-PCR).

Official Title
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Effect of Smoking Cessation on Clinical and Microbiological Outcomes of the Non-surgical Periodontal Therapy

Conditions
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Periodontitis

Intervention / Treatment
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* Behavioral: Smoking cessation counseling
* Procedure: Non-surgical periodontal therapy
* Drug: Nicotine replacement therapy
* Drug: bupropion hydrochloride
* Drug: Varenicline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: smokers willing to stop smoking >10 teeth periodontitis (30% or more of their teeth with proximal attachment loss ≥ 5 mm) Exclusion Criteria: systemic conditions considered as risk factors for periodontal disease, periodontal therapy in the last 6 months continuous systemic use of anti-inflammatory or steroidal drugs

Ages Eligible for Study
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Minimum Age: 18 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Smoking cessation therapy<br>Non-surgical periodontal therapy and concurrent smoking cessation therapy, with Smoking cessation counseling, Nicotine replacement therapy, use of bupropion hydrochloride and varenicline | Behavioral: Smoking cessation counseling<br>* Multidisciplinary smoking cessation counseling, performed by a team comprising physicians, nurses, a psychologist and dentists. It consisted of four 1-h counselling lectures delivered by physicians, psychologist-assisted cognitive behavioural therapy, and counseling provided by dentists during the active phase of the treatment and maintenance session, using motivational interviewing techniques<br>Procedure: Non-surgical periodontal therapy<br>* Full-mouth supra and subgingival scaling and root planing (with curettes and ultrasonic scaler); oral hygiene instruction and motivation and removal of intra-oral plaque retentive factors<br>Drug: Nicotine replacement therapy<br>* Nicotine replacement therapy: chewing gum (Nicorette chewing gum 2-4mg) and patches (Nicorette patches 15-25mg)<br>* Other names: Nicorette;Drug: bupropion hydrochloride<br>* bupropion hydrochloride 150mg<br>* Other names: Zyban;Drug: Varenicline<br>* Varenicline 0,5mg<br>* Other names: Champix;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Clinical Attachment Level | Change in Clinical Attachment Level (millimeters) after 12 months | baseline - 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Gingival recession | Change in Gingival recession (millimeters) after 12 months | baseline - 12 months | 
| Change in Pocket depth | Change in Pocket depth (millimeters) after 12 months | baseline - 12 months | 
| Change in bleeding on probing | Change in bleeding on probing (percentage of sites with bleeding) after 12 months | baseline - 12 months | 
| Change in visible plaque | Change in visible plaque (percentage of sites with visible plaque) after 12 months | baseline - 12 months | 
| Prevalence and levels of Aggregatibacter actinomycetemcomitans | Prevalence and levels of Aggregatibacter actinomycetemcomitans determined by means of (RT-PCR). | baseline - 12 months | 
| Prevalence and levels of Porphyromonas gingivalis | Prevalence and levels of Porphyromonas gingivalis, determined by means of (RT-PCR). | baseline - 12 months | 
| Prevalence and levels of Tannerella forsythia | Prevalence and levels of Tanerella forsythia, determined by means of RT-PCR | baseline - 12 months | 
| Prevalence and levels of Treponema denticola | Prevalence and levels of Treponema denticola, determined by means of RT-PCR | baseline - 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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smoking cessation, tobacco, periodontal, subgingival microorganisms