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

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ClinicalTrials.gov Identifier: NCT02493270
Recruitment Status : Completed
First Posted : July 9, 2015
Last Update Posted : April 15, 2016
Sponsor:
Information provided by (Responsible Party):
Claudio Mendes Pannuti, University of Sao Paulo

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.


Condition or disease Intervention/treatment Phase
Periodontitis Behavioral: Smoking cessation therapy Procedure: Non-surgical periodontal therapy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 177 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Smoking Cessation on Non-surgical Periodontal Therapy
Study Start Date : May 2007
Actual Primary Completion Date : May 2014
Actual Study Completion Date : June 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Adjunctive smoking cessation
non-surgical periodontal therapy and concurrent smoking cessation therapy
Behavioral: Smoking cessation therapy
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

Procedure: Non-surgical periodontal therapy
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 Measures :
  1. Change in Clinical Attachment Level (millimeters) after 24 months [ Time Frame: baseline and 24 months ]

Secondary Outcome Measures :
  1. Change in Gingival recession (millimeters) after 24 months [ Time Frame: baseline and 24 months ]
  2. Change in Pocket depth (millimeters) after 24 months [ Time Frame: baseline and 24 months ]
  3. Change in bleeding on probing (percentage of sites with bleeding) after 24 months [ Time Frame: baseline and 24 months ]
  4. Change in visible plaque (percentage of sites with visible plaque) after 24 months [ Time Frame: baseline and 24 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02493270


Sponsors and Collaborators
University of Sao Paulo
Investigators
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Principal Investigator: Claudio M Pannuti, PhD University of São Paulo

Publications of Results:
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Responsible Party: Claudio Mendes Pannuti, Associate Professor, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT02493270     History of Changes
Other Study ID Numbers: EsCAPE
First Posted: July 9, 2015    Key Record Dates
Last Update Posted: April 15, 2016
Last Verified: April 2016
Keywords provided by Claudio Mendes Pannuti, University of Sao Paulo:
smoking cessation
tobacco
dental
periodontal
Additional relevant MeSH terms:
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Periodontitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases