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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02744417
Acronym
EsCAPE2
Enrollment
63
Registered
2016-04-20
Start date
2010-08-31
Completion date
2014-03-31
Last updated
2018-11-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Periodontitis

Keywords

smoking cessation, tobacco, periodontal, subgingival microorganisms

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).

Interventions

BEHAVIORALSmoking 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

PROCEDURENon-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

DRUGNicotine replacement therapy

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

bupropion hydrochloride 150mg

DRUGVarenicline

Varenicline 0,5mg

Sponsors

Claudio Mendes Pannuti
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

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

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Change in Clinical Attachment Levelbaseline - 12 monthsChange in Clinical Attachment Level (millimeters) after 12 months

Secondary

MeasureTime frameDescription
Change in Pocket depthbaseline - 12 monthsChange in Pocket depth (millimeters) after 12 months
Change in bleeding on probingbaseline - 12 monthsChange in bleeding on probing (percentage of sites with bleeding) after 12 months
Change in visible plaquebaseline - 12 monthsChange in visible plaque (percentage of sites with visible plaque) after 12 months
Change in Gingival recessionbaseline - 12 monthsChange in Gingival recession (millimeters) after 12 months
Prevalence and levels of Porphyromonas gingivalisbaseline - 12 monthsPrevalence and levels of Porphyromonas gingivalis, determined by means of (RT-PCR).
Prevalence and levels of Tannerella forsythiabaseline - 12 monthsPrevalence and levels of Tanerella forsythia, determined by means of RT-PCR
Prevalence and levels of Treponema denticolabaseline - 12 monthsPrevalence and levels of Treponema denticola, determined by means of RT-PCR
Prevalence and levels of Aggregatibacter actinomycetemcomitansbaseline - 12 monthsPrevalence and levels of Aggregatibacter actinomycetemcomitans determined by means of (RT-PCR).

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026