NCT02493270

Brief Summary

The aim of this prospective study is to verify the efficacy of smoking cessation on non-surgical periodontal therapy in adult subjects with chronic periodontitis. Smokers that were willing to quit received periodontal treatment and concurrent smoking cessation therapy. Periodontal maintenance was performed every 3 months. A calibrated examiner, blinded to smoking status, assessed periodontal status, gathered demographic and behavioural information with a structured questionnaire and measured air carbon monoxide concentration measurements.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
177

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2007

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2007

Completed
7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

July 2, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 9, 2015

Completed
Last Updated

April 15, 2016

Status Verified

April 1, 2016

Enrollment Period

7 years

First QC Date

July 2, 2015

Last Update Submit

April 13, 2016

Conditions

Periodontitis

Keywords

smoking cessationtobaccodentalperiodontal

Outcome Measures

Primary Outcomes (1)

  • Change in Clinical Attachment Level (millimeters) after 24 months

    baseline and 24 months

Secondary Outcomes (4)

  • Change in Gingival recession (millimeters) after 24 months

    baseline and 24 months

  • Change in Pocket depth (millimeters) after 24 months

    baseline and 24 months

  • Change in bleeding on probing (percentage of sites with bleeding) after 24 months

    baseline and 24 months

  • Change in visible plaque (percentage of sites with visible plaque) after 24 months

    baseline and 24 months

Study Arms (1)

Adjunctive smoking cessation

EXPERIMENTAL

non-surgical periodontal therapy and concurrent smoking cessation therapy

Behavioral: Smoking cessation therapyProcedure: Non-surgical periodontal therapy

Interventions

Smoking cessation therapyBEHAVIORAL

Multidisciplinary smoking cessation therapy, performed by a team comprising physicians, nurses, a psychologist and dentists. It consisted of four 1-h counselling lectures, psychologist-assisted cognitive behavioural 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

Adjunctive smoking cessation
Non-surgical periodontal therapyPROCEDURE

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

Adjunctive smoking cessation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • subjects were willing to stop smoking
  • \>10 teeth
  • periodontitis (30% or more of their teeth with proximal CAL ≥ 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Rosa EF, Corraini P, Inoue G, Gomes EF, Guglielmetti MR, Sanda SR, Lotufo JP, Romito GA, Pannuti CM. Effect of smoking cessation on non-surgical periodontal therapy: results after 24 months. J Clin Periodontol. 2014 Dec;41(12):1145-53. doi: 10.1111/jcpe.12313. Epub 2014 Nov 21.

    PMID: 25265872RESULT

  • Rosa EF, Corraini P, de Carvalho VF, Inoue G, Gomes EF, Lotufo JP, De Micheli G, Pannuti CM. A prospective 12-month study of the effect of smoking cessation on periodontal clinical parameters. J Clin Periodontol. 2011 Jun;38(6):562-71. doi: 10.1111/j.1600-051X.2011.01723.x. Epub 2011 Apr 13.

    PMID: 21488933RESULT

MeSH Terms

Conditions

PeriodontitisSmoking Cessation

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic DiseasesHealth BehaviorBehavior

Study Officials

  • Claudio M Pannuti, PhD

    University of Sao Paulo

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

July 2, 2015

First Posted

July 9, 2015

Study Start

May 1, 2007

Primary Completion

May 1, 2014

Study Completion

June 1, 2014

Last Updated

April 15, 2016

Record last verified: 2016-04