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

Periodontitis Clinical Trial

— EsCAPE2  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02744417
• Other study ID #: EsCAPE2
• Status: Completed
• Phase: N/A
• Start date: August 2010
• Est. completion date: March 2014

Study information

• Verified date: November 2018
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: March 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Periodontitis

Intervention

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)
• bupropion hydrochloride
bupropion hydrochloride 150mg
• Varenicline
Varenicline 0,5mg

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Claudio Mendes Pannuti

References & Publications (1)

Guglielmetti MR, Rosa EF, Lourenção 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 cha — View Citation

Outcome

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