Clinical trial NCT02744417: Effect of Smoking Cessation on Clinical and Microbiological Outcomes of the Non-surgical Periodontal Therapy
Official title: Effect of Smoking Cessation on Clinical and Microbiological Outcomes of the Non-surgical Periodontal Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Periodontitis
Keywords: smoking cessation
tobacco
periodontal
subgingival microorganisms
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2016-04-20
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

Eligibility criteria: 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

Primary outcomes:
measure: Change in Clinical Attachment Level
timeFrame: baseline - 12 months
Secondary outcomes:
measure: Change in Gingival recession
timeFrame: baseline - 12 months
measure: Change in Pocket depth
timeFrame: baseline - 12 months
measure: Change in bleeding on probing
timeFrame: baseline - 12 months
measure: Change in visible plaque
timeFrame: baseline - 12 months
measure: Prevalence and levels of Aggregatibacter actinomycetemcomitans
timeFrame: baseline - 12 months
measure: Prevalence and levels of Porphyromonas gingivalis
timeFrame: baseline - 12 months
measure: Prevalence and levels of Tannerella forsythia
timeFrame: baseline - 12 months
measure: Prevalence and levels of Treponema denticola
timeFrame: baseline - 12 months
Other outcomes:
Locations:
Study officials:
affiliation: University of Sao Paulo
name: Claudio M Pannuti, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.