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

NCT02744417 | Completed

• 1 other identifier: EsCAPE2
• Study Type: interventional
• Target: 63
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Periodontitis

Keywords

smoking cessation; tobacco; periodontal; subgingival microorganisms

Outcome Measures

Primary Outcomes (1)

• Change in Clinical Attachment Level

  Change in Clinical Attachment Level (millimeters) after 12 months

  baseline - 12 months

Secondary Outcomes (8)

• Change in Gingival recession

  baseline - 12 months

• Change in Pocket depth

  baseline - 12 months

• Change in bleeding on probing

  baseline - 12 months

• Change in visible plaque

  baseline - 12 months

• Prevalence and levels of Aggregatibacter actinomycetemcomitans

  baseline - 12 months

Study Arms (1)

Smoking cessation therapy

EXPERIMENTAL

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; Procedure: Non-surgical periodontal therapy; Drug: Nicotine replacement therapy; Drug: bupropion hydrochloride; Drug: Varenicline

Interventions

Smoking cessation counseling BEHAVIORAL

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

Smoking cessation therapy

Non-surgical periodontal therapy PROCEDURE

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

Smoking cessation therapy

Nicotine replacement therapy DRUG

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

Also known as: Nicorette

Smoking cessation therapy

bupropion hydrochloride DRUG

bupropion hydrochloride 150mg

Also known as: Zyban

Smoking cessation therapy

Varenicline DRUG

Varenicline 0,5mg

Also known as: Champix

Smoking cessation therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• smokers willing to stop smoking
• \>10 teeth
• periodontitis (30% or more of their teeth with proximal attachment loss ≥ 5 mm)

You may not qualify if:

• 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

Sponsors & Collaborators

• Claudio Mendes Pannuti: lead

Related Publications (1)

• 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.

  PMID: 24794687 RESULT

MeSH Terms

Conditions

Periodontitis; Smoking Cessation

Interventions

Nicotine Replacement Therapy; Nicotine Chewing Gum; Bupropion; Varenicline

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics; Chewing Gum; Plant Gums; Biopolymers; Polymers; Macromolecular Substances; Polysaccharides; Carbohydrates; Tobacco Use Cessation Devices; Candy; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Propiophenones; Ketones; Organic Chemicals; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Quinoxalines

Study Officials

• Claudio M Pannuti, PhD

  University of Sao Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: 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
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 13, 2016
• First Posted: April 20, 2016
• Study Start: August 1, 2010
• Primary Completion: February 1, 2014
• Study Completion: March 1, 2014
• Last Updated: November 6, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share