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临床试验/NCT02744417
NCT02744417已完成不适用

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

Claudio Mendes Pannuti0 个研究点目标入组 63 人开始时间: 2010年8月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
63
主要终点
Change in Clinical Attachment Level

研究概览

简要总结

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).

详细描述

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).

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

盲法说明

The outcome assessor was blind to smoking status. Before each follow-up periodontal examination (3, 6 and 12 months), the following procedures were performed by a periodontist: (1) removal of all tobacco stains from subject's teeth and/or dental polishing, with a standardized duration of up to 30 min., (2) 0.12% chlorohexidine rinse (1min.) aimed to hide any possible cigarette odour exhaled from the oral cavity. After these procedures, the examiner entered the examination room fully equipped (including a mask), in order to avoid noticing the smoking status by odour

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • smokers willing to stop smoking
  • >10 teeth
  • periodontitis (30% or more of their teeth with proximal attachment loss ≥ 5 mm)

排除标准

  • 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

研究组 & 干预措施

Smoking cessation therapy

Experimental

Non-surgical periodontal therapy and concurrent smoking cessation therapy, with Smoking cessation counseling, Nicotine replacement therapy, use of bupropion hydrochloride and varenicline

干预措施: Smoking cessation counseling (Behavioral)

Smoking cessation therapy

Experimental

Non-surgical periodontal therapy and concurrent smoking cessation therapy, with Smoking cessation counseling, Nicotine replacement therapy, use of bupropion hydrochloride and varenicline

干预措施: Non-surgical periodontal therapy (Procedure)

Smoking cessation therapy

Experimental

Non-surgical periodontal therapy and concurrent smoking cessation therapy, with Smoking cessation counseling, Nicotine replacement therapy, use of bupropion hydrochloride and varenicline

干预措施: Nicotine replacement therapy (Drug)

Smoking cessation therapy

Experimental

Non-surgical periodontal therapy and concurrent smoking cessation therapy, with Smoking cessation counseling, Nicotine replacement therapy, use of bupropion hydrochloride and varenicline

干预措施: bupropion hydrochloride (Drug)

Smoking cessation therapy

Experimental

Non-surgical periodontal therapy and concurrent smoking cessation therapy, with Smoking cessation counseling, Nicotine replacement therapy, use of bupropion hydrochloride and varenicline

干预措施: Varenicline (Drug)

结局指标

主要结局

Change in Clinical Attachment Level

时间窗: baseline - 12 months

Change in Clinical Attachment Level (millimeters) after 12 months

次要结局

  • Prevalence and levels of Tannerella forsythia(baseline - 12 months)
  • Prevalence and levels of Treponema denticola(baseline - 12 months)
  • Change in bleeding on probing(baseline - 12 months)
  • Change in Gingival recession(baseline - 12 months)
  • Change in Pocket depth(baseline - 12 months)
  • Change in visible plaque(baseline - 12 months)
  • Prevalence and levels of Aggregatibacter actinomycetemcomitans(baseline - 12 months)
  • Prevalence and levels of Porphyromonas gingivalis(baseline - 12 months)

研究者

发起方
Claudio Mendes Pannuti
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Claudio Mendes Pannuti

Associate Professor

University of Sao Paulo

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