Effect of Smoking Cessation on Clinical and Microbiological Outcomes of the Non-surgical Periodontal Therapy
- Conditions
- Periodontitis
- Interventions
- Behavioral: Smoking cessation counselingProcedure: Non-surgical periodontal therapy
- Registration Number
- NCT02744417
- Lead Sponsor
- Claudio Mendes Pannuti
- Brief Summary
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
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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 63
- smokers willing to stop smoking
- >10 teeth
- periodontitis (30% or more of their teeth with proximal attachment loss ≥ 5 mm)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Smoking cessation therapy Nicotine replacement therapy Non-surgical periodontal therapy and concurrent smoking cessation therapy, with Smoking cessation counseling, Nicotine replacement therapy, use of bupropion hydrochloride and varenicline Smoking cessation therapy Varenicline Non-surgical periodontal therapy and concurrent smoking cessation therapy, with Smoking cessation counseling, Nicotine replacement therapy, use of bupropion hydrochloride and varenicline Smoking cessation therapy Smoking cessation counseling Non-surgical periodontal therapy and concurrent smoking cessation therapy, with Smoking cessation counseling, Nicotine replacement therapy, use of bupropion hydrochloride and varenicline Smoking cessation therapy Non-surgical periodontal therapy Non-surgical periodontal therapy and concurrent smoking cessation therapy, with Smoking cessation counseling, Nicotine replacement therapy, use of bupropion hydrochloride and varenicline Smoking cessation therapy bupropion hydrochloride Non-surgical periodontal therapy and concurrent smoking cessation therapy, with Smoking cessation counseling, Nicotine replacement therapy, use of bupropion hydrochloride and varenicline
- Primary Outcome Measures
Name Time Method Change in Clinical Attachment Level baseline - 12 months Change in Clinical Attachment Level (millimeters) after 12 months
- Secondary Outcome Measures
Name Time Method Prevalence and levels of Tannerella forsythia baseline - 12 months Prevalence and levels of Tanerella forsythia, determined by means of RT-PCR
Prevalence and levels of Treponema denticola baseline - 12 months Prevalence and levels of Treponema denticola, determined by means of RT-PCR
Change in bleeding on probing baseline - 12 months Change in bleeding on probing (percentage of sites with bleeding) after 12 months
Change in Gingival recession baseline - 12 months Change in Gingival recession (millimeters) after 12 months
Change in Pocket depth baseline - 12 months Change in Pocket depth (millimeters) after 12 months
Change in visible plaque baseline - 12 months Change in visible plaque (percentage of sites with visible plaque) after 12 months
Prevalence and levels of Aggregatibacter actinomycetemcomitans baseline - 12 months Prevalence and levels of Aggregatibacter actinomycetemcomitans determined by means of (RT-PCR).
Prevalence and levels of Porphyromonas gingivalis baseline - 12 months Prevalence and levels of Porphyromonas gingivalis, determined by means of (RT-PCR).