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Effect of Smoking Cessation on Clinical and Microbiological Outcomes of the Non-surgical Periodontal Therapy (EsCAPE2)

Primary Purpose

Periodontitis

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Smoking cessation counseling
Non-surgical periodontal therapy
Nicotine replacement therapy
bupropion hydrochloride
Varenicline
Sponsored by
Claudio Mendes Pannuti
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Periodontitis focused on measuring smoking cessation, tobacco, periodontal, subgingival microorganisms

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Smoking cessation therapy

    Arm Description

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

    Outcomes

    Primary Outcome Measures

    Change in Clinical Attachment Level
    Change in Clinical Attachment Level (millimeters) after 12 months

    Secondary Outcome Measures

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

    Full Information

    First Posted
    April 13, 2016
    Last Updated
    November 3, 2018
    Sponsor
    Claudio Mendes Pannuti
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02744417
    Brief Title
    Effect of Smoking Cessation on Clinical and Microbiological Outcomes of the Non-surgical Periodontal Therapy
    Acronym
    EsCAPE2
    Official Title
    Effect of Smoking Cessation on Clinical and Microbiological Outcomes of the Non-surgical Periodontal Therapy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    August 2010 (undefined)
    Primary Completion Date
    February 2014 (Actual)
    Study Completion Date
    March 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Claudio Mendes Pannuti

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Periodontitis
    Keywords
    smoking cessation, tobacco, periodontal, subgingival microorganisms

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Masking Description
    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
    Allocation
    N/A
    Enrollment
    63 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Smoking cessation therapy
    Arm Type
    Experimental
    Arm Description
    Non-surgical periodontal therapy and concurrent smoking cessation therapy, with Smoking cessation counseling, Nicotine replacement therapy, use of bupropion hydrochloride and varenicline
    Intervention Type
    Behavioral
    Intervention Name(s)
    Smoking cessation counseling
    Intervention Description
    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
    Intervention Type
    Procedure
    Intervention Name(s)
    Non-surgical periodontal therapy
    Intervention Description
    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
    Intervention Type
    Drug
    Intervention Name(s)
    Nicotine replacement therapy
    Other Intervention Name(s)
    Nicorette
    Intervention Description
    Nicotine replacement therapy: chewing gum (Nicorette chewing gum 2-4mg) and patches (Nicorette patches 15-25mg)
    Intervention Type
    Drug
    Intervention Name(s)
    bupropion hydrochloride
    Other Intervention Name(s)
    Zyban
    Intervention Description
    bupropion hydrochloride 150mg
    Intervention Type
    Drug
    Intervention Name(s)
    Varenicline
    Other Intervention Name(s)
    Champix
    Intervention Description
    Varenicline 0,5mg
    Primary Outcome Measure Information:
    Title
    Change in Clinical Attachment Level
    Description
    Change in Clinical Attachment Level (millimeters) after 12 months
    Time Frame
    baseline - 12 months
    Secondary Outcome Measure Information:
    Title
    Change in Gingival recession
    Description
    Change in Gingival recession (millimeters) after 12 months
    Time Frame
    baseline - 12 months
    Title
    Change in Pocket depth
    Description
    Change in Pocket depth (millimeters) after 12 months
    Time Frame
    baseline - 12 months
    Title
    Change in bleeding on probing
    Description
    Change in bleeding on probing (percentage of sites with bleeding) after 12 months
    Time Frame
    baseline - 12 months
    Title
    Change in visible plaque
    Description
    Change in visible plaque (percentage of sites with visible plaque) after 12 months
    Time Frame
    baseline - 12 months
    Title
    Prevalence and levels of Aggregatibacter actinomycetemcomitans
    Description
    Prevalence and levels of Aggregatibacter actinomycetemcomitans determined by means of (RT-PCR).
    Time Frame
    baseline - 12 months
    Title
    Prevalence and levels of Porphyromonas gingivalis
    Description
    Prevalence and levels of Porphyromonas gingivalis, determined by means of (RT-PCR).
    Time Frame
    baseline - 12 months
    Title
    Prevalence and levels of Tannerella forsythia
    Description
    Prevalence and levels of Tanerella forsythia, determined by means of RT-PCR
    Time Frame
    baseline - 12 months
    Title
    Prevalence and levels of Treponema denticola
    Description
    Prevalence and levels of Treponema denticola, determined by means of RT-PCR
    Time Frame
    baseline - 12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Claudio M Pannuti, PhD
    Organizational Affiliation
    University of Sao Paulo
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    24794687
    Citation
    Guglielmetti MR, Rosa EF, Lourencao DS, Inoue G, Gomes EF, De Micheli G, Mendes FM, Hirata RD, Hirata MH, Pannuti CM. Detection and quantification of periodontal pathogens in smokers and never-smokers with chronic periodontitis by real-time polymerase chain reaction. J Periodontol. 2014 Oct;85(10):1450-7. doi: 10.1902/jop.2014.140048. Epub 2014 May 2.
    Results Reference
    result

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

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