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Clinical Trials/NCT02744417
NCT02744417
Completed
Not Applicable

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

Claudio Mendes Pannuti0 sites63 target enrollmentAugust 2010

Overview

Phase
Not Applicable
Intervention
Smoking cessation counseling
Conditions
Periodontitis
Sponsor
Claudio Mendes Pannuti
Enrollment
63
Primary Endpoint
Change in Clinical Attachment Level
Status
Completed
Last Updated
7 years ago

Overview

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).

Registry
clinicaltrials.gov
Start Date
August 2010
End Date
March 2014
Last Updated
7 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Claudio Mendes Pannuti
Responsible Party
Sponsor Investigator
Principal Investigator

Claudio Mendes Pannuti

Associate Professor

University of Sao Paulo

Eligibility Criteria

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

Arms & Interventions

Smoking cessation therapy

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

Intervention: Smoking cessation counseling

Smoking cessation therapy

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

Intervention: Non-surgical periodontal therapy

Smoking cessation therapy

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

Intervention: Nicotine replacement therapy

Smoking cessation therapy

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

Intervention: bupropion hydrochloride

Smoking cessation therapy

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

Intervention: Varenicline

Outcomes

Primary Outcomes

Change in Clinical Attachment Level

Time Frame: baseline - 12 months

Change in Clinical Attachment Level (millimeters) after 12 months

Secondary Outcomes

  • 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)

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