NCT Number: NCT02744417
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).
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Notify Me18 year and older
All sexes
Interventional
Not applicable
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).
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
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
Nicotine replacement therapy: chewing gum (Nicorette chewing gum 2-4mg) and patches (Nicorette patches 15-25mg)
Other names: Nicorette
bupropion hydrochloride 150mg
Other names: Zyban
Varenicline 0,5mg
Other names: Champix
Time frame: baseline - 12 months
Change in Clinical Attachment Level (millimeters) after 12 months
Time frame: baseline - 12 months
Change in Gingival recession (millimeters) after 12 months
Time frame: baseline - 12 months
Change in Pocket depth (millimeters) after 12 months
Time frame: baseline - 12 months
Change in bleeding on probing (percentage of sites with bleeding) after 12 months
Time frame: baseline - 12 months
Change in visible plaque (percentage of sites with visible plaque) after 12 months
Time frame: baseline - 12 months
Prevalence and levels of Aggregatibacter actinomycetemcomitans determined by means of (RT-PCR).
Time frame: baseline - 12 months
Prevalence and levels of Porphyromonas gingivalis, determined by means of (RT-PCR).
Time frame: baseline - 12 months
Prevalence and levels of Tanerella forsythia, determined by means of RT-PCR
Time frame: baseline - 12 months
Prevalence and levels of Treponema denticola, determined by means of RT-PCR
Claudio Mendes Pannuti
Other
Acronym: EsCAPE2
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