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Effect of Smoking Cessation on Non-surgical Periodontal Therapy (EsCAPE)

Primary Purpose

Periodontitis

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Smoking cessation therapy
Non-surgical periodontal therapy
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

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

Eligibility Criteria

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

Inclusion Criteria:

  • subjects were willing to stop smoking
  • >10 teeth
  • periodontitis (30% or more of their teeth with proximal CAL ≥ 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

    Adjunctive smoking cessation

    Arm Description

    non-surgical periodontal therapy and concurrent smoking cessation therapy

    Outcomes

    Primary Outcome Measures

    Change in Clinical Attachment Level (millimeters) after 24 months

    Secondary Outcome Measures

    Change in Gingival recession (millimeters) after 24 months
    Change in Pocket depth (millimeters) after 24 months
    Change in bleeding on probing (percentage of sites with bleeding) after 24 months
    Change in visible plaque (percentage of sites with visible plaque) after 24 months

    Full Information

    First Posted
    July 2, 2015
    Last Updated
    April 13, 2016
    Sponsor
    University of Sao Paulo
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02493270
    Brief Title
    Effect of Smoking Cessation on Non-surgical Periodontal Therapy
    Acronym
    EsCAPE
    Official Title
    Effect of Smoking Cessation on Non-surgical Periodontal Therapy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    May 2007 (undefined)
    Primary Completion Date
    May 2014 (Actual)
    Study Completion Date
    June 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Sao Paulo

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The aim of this prospective study is to verify the efficacy of smoking cessation on non-surgical periodontal therapy in adult subjects with chronic periodontitis. Smokers that were willing to quit received periodontal treatment and concurrent smoking cessation therapy. Periodontal maintenance was performed every 3 months. A calibrated examiner, blinded to smoking status, assessed periodontal status, gathered demographic and behavioural information with a structured questionnaire and measured air carbon monoxide concentration measurements.

    6. Conditions and Keywords

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

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    Adjunctive smoking cessation
    Arm Type
    Experimental
    Arm Description
    non-surgical periodontal therapy and concurrent smoking cessation therapy
    Intervention Type
    Behavioral
    Intervention Name(s)
    Smoking cessation therapy
    Intervention Description
    Multidisciplinary smoking cessation therapy, performed by a team comprising physicians, nurses, a psychologist and dentists. It consisted of four 1-h counselling lectures, psychologist-assisted cognitive behavioural 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
    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
    Primary Outcome Measure Information:
    Title
    Change in Clinical Attachment Level (millimeters) after 24 months
    Time Frame
    baseline and 24 months
    Secondary Outcome Measure Information:
    Title
    Change in Gingival recession (millimeters) after 24 months
    Time Frame
    baseline and 24 months
    Title
    Change in Pocket depth (millimeters) after 24 months
    Time Frame
    baseline and 24 months
    Title
    Change in bleeding on probing (percentage of sites with bleeding) after 24 months
    Time Frame
    baseline and 24 months
    Title
    Change in visible plaque (percentage of sites with visible plaque) after 24 months
    Time Frame
    baseline and 24 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: subjects were willing to stop smoking >10 teeth periodontitis (30% or more of their teeth with proximal CAL ≥ 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 São Paulo
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    25265872
    Citation
    Rosa EF, Corraini P, Inoue G, Gomes EF, Guglielmetti MR, Sanda SR, Lotufo JP, Romito GA, Pannuti CM. Effect of smoking cessation on non-surgical periodontal therapy: results after 24 months. J Clin Periodontol. 2014 Dec;41(12):1145-53. doi: 10.1111/jcpe.12313. Epub 2014 Nov 21.
    Results Reference
    result
    PubMed Identifier
    21488933
    Citation
    Rosa EF, Corraini P, de Carvalho VF, Inoue G, Gomes EF, Lotufo JP, De Micheli G, Pannuti CM. A prospective 12-month study of the effect of smoking cessation on periodontal clinical parameters. J Clin Periodontol. 2011 Jun;38(6):562-71. doi: 10.1111/j.1600-051X.2011.01723.x. Epub 2011 Apr 13.
    Results Reference
    result

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    Effect of Smoking Cessation on Non-surgical Periodontal Therapy

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