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

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).

Study Overview

• Status: Completed
• Conditions: Periodontitis
• Intervention / Treatment: Behavioral: Smoking cessation counseling; Procedure: Non-surgical periodontal therapy; Drug: Nicotine replacement therapy; Drug: bupropion hydrochloride; Drug: Varenicline

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).

• Study Type: Interventional
• Enrollment (Actual): 63
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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 Names: Nicorette; Drug: bupropion hydrochloride; bupropion hydrochloride 150mg; Other Names: Zyban; Drug: Varenicline; Varenicline 0,5mg; Other Names: Champix

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Clinical Attachment Level	Change in Clinical Attachment Level (millimeters) after 12 months	baseline - 12 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Claudio Mendes Pannuti
• Investigators: Principal Investigator: Claudio M Pannuti, PhD, University of Sao Paulo

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: August 1, 2010
• Primary Completion (Actual): February 1, 2014
• Study Completion (Actual): March 1, 2014

Study Registration Dates

• First Submitted: April 13, 2016
• First Submitted That Met QC Criteria: April 15, 2016
• First Posted (Estimate): April 20, 2016

Study Record Updates

• Last Update Posted (Actual): November 6, 2018
• Last Update Submitted That Met QC Criteria: November 3, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: smoking cessation; tobacco; periodontal; subgingival microorganisms
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Agents; Enzyme Inhibitors; Psychotropic Drugs; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Antidepressive Agents; Dopamine Agents; Cytochrome P-450 Enzyme Inhibitors; Ganglionic Stimulants; Nicotinic Agonists; Cholinergic Agonists; Antidepressive Agents, Second-Generation; Cytochrome P-450 CYP2D6 Inhibitors; Dopamine Uptake Inhibitors; Nicotine; Bupropion; Varenicline
• Other Study ID Numbers: EsCAPE2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No