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
About this trial
This is an interventional treatment trial for Periodontitis focused on measuring smoking cessation, tobacco, periodontal, subgingival microorganisms
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
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
NCT ID
NCT02744417
First Posted
April 13, 2016
Last Updated
November 3, 2018
Sponsor
Claudio Mendes Pannuti
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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