Effect of Smoking Cessation on Non-surgical Periodontal Therapy (EsCAPE)

April 13, 2016 updated by: Claudio Mendes Pannuti, University of Sao Paulo

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

177

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Adjunctive smoking cessation
non-surgical periodontal therapy and concurrent smoking cessation therapy
Behavioral: Smoking cessation therapy
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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in Clinical Attachment Level (millimeters) after 24 months
Time Frame: baseline and 24 months
baseline and 24 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in Gingival recession (millimeters) after 24 months
Time Frame: baseline and 24 months
baseline and 24 months
Change in Pocket depth (millimeters) after 24 months
Time Frame: baseline and 24 months
baseline and 24 months
Change in bleeding on probing (percentage of sites with bleeding) after 24 months
Time Frame: baseline and 24 months
baseline and 24 months
Change in visible plaque (percentage of sites with visible plaque) after 24 months
Time Frame: baseline and 24 months
baseline and 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo

Investigators

  • Principal Investigator: Claudio M Pannuti, PhD, University of Sao Paulo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2007

Primary Completion (Actual)

May 1, 2014

Study Completion (Actual)

June 1, 2014

Study Registration Dates

First Submitted

July 2, 2015

First Submitted That Met QC Criteria

July 6, 2015

First Posted (Estimate)

July 9, 2015

Study Record Updates

Last Update Posted (Estimate)

April 15, 2016

Last Update Submitted That Met QC Criteria

April 13, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Escape

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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