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

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ClinicalTrials.gov Identifier: NCT02744417
Recruitment Status : Completed
First Posted : April 20, 2016
Last Update Posted : November 6, 2018
Sponsor:
Information provided by (Responsible Party):
Claudio Mendes Pannuti, University of Sao Paulo

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).

Condition or disease Intervention/treatment Phase
Periodontitis Behavioral: Smoking cessation counseling Procedure: Non-surgical periodontal therapy Drug: Nicotine replacement therapy Drug: bupropion hydrochloride Drug: Varenicline Not Applicable

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).


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 63 participants
Intervention 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
Primary Purpose: Treatment
Official Title: Effect of Smoking Cessation on Clinical and Microbiological Outcomes of the Non-surgical Periodontal Therapy
Study Start Date : August 2010
Actual Primary Completion Date : February 2014
Actual Study Completion Date : March 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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
Behavioral: Smoking cessation counseling
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

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

Drug: Nicotine replacement therapy
Nicotine replacement therapy: chewing gum (Nicorette chewing gum 2-4mg) and patches (Nicorette patches 15-25mg)
Other Name: Nicorette

Drug: bupropion hydrochloride
bupropion hydrochloride 150mg
Other Name: Zyban

Drug: Varenicline
Varenicline 0,5mg
Other Name: Champix




Primary Outcome Measures :
  1. Change in Clinical Attachment Level [ Time Frame: baseline - 12 months ]
    Change in Clinical Attachment Level (millimeters) after 12 months


Secondary Outcome Measures :
  1. Change in Gingival recession [ Time Frame: baseline - 12 months ]
    Change in Gingival recession (millimeters) after 12 months

  2. Change in Pocket depth [ Time Frame: baseline - 12 months ]
    Change in Pocket depth (millimeters) after 12 months

  3. Change in bleeding on probing [ Time Frame: baseline - 12 months ]
    Change in bleeding on probing (percentage of sites with bleeding) after 12 months

  4. Change in visible plaque [ Time Frame: baseline - 12 months ]
    Change in visible plaque (percentage of sites with visible plaque) after 12 months

  5. Prevalence and levels of Aggregatibacter actinomycetemcomitans [ Time Frame: baseline - 12 months ]
    Prevalence and levels of Aggregatibacter actinomycetemcomitans determined by means of (RT-PCR).

  6. Prevalence and levels of Porphyromonas gingivalis [ Time Frame: baseline - 12 months ]
    Prevalence and levels of Porphyromonas gingivalis, determined by means of (RT-PCR).

  7. Prevalence and levels of Tannerella forsythia [ Time Frame: baseline - 12 months ]
    Prevalence and levels of Tanerella forsythia, determined by means of RT-PCR

  8. Prevalence and levels of Treponema denticola [ Time Frame: baseline - 12 months ]
    Prevalence and levels of Treponema denticola, determined by means of RT-PCR



Information from the National Library of Medicine

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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:

  • 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

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): NCT02744417


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

Publications of Results:
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Responsible Party: Claudio Mendes Pannuti, Associate Professor, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT02744417     History of Changes
Other Study ID Numbers: EsCAPE2
First Posted: April 20, 2016    Key Record Dates
Last Update Posted: November 6, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Claudio Mendes Pannuti, University of Sao Paulo:
smoking cessation
tobacco
periodontal
subgingival microorganisms
Additional relevant MeSH terms:
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Periodontitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Bupropion
Nicotine
Varenicline
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Dopamine Agents
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors