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

Claudio Mendes Pannuti

Status: Completed

Conditions: Periodontitis

Treatments: Procedure: Non-surgical periodontal therapy; Behavioral: Smoking cessation counseling; Drug: Varenicline; Drug: Nicotine replacement therapy; Drug: bupropion hydrochloride

Study type: Interventional

Funder types: Other

Identifiers

NCT02744417

EsCAPE2

Details and patient eligibility

About

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).

Full 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).

Enrollment: 63 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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63 participants in 1 patient group

Smoking cessation therapy

Experimental group

Description:

Non-surgical periodontal therapy and concurrent smoking cessation therapy, with Smoking cessation counseling, Nicotine replacement therapy, use of bupropion hydrochloride and varenicline

Treatment:

Drug: bupropion hydrochloride

Drug: Nicotine replacement therapy

Drug: Varenicline

Procedure: Non-surgical periodontal therapy

Behavioral: Smoking cessation counseling