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Completed

NCT Number: NCT02493270

Effect of Smoking Cessation on Non-surgical Periodontal Therapy

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.

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Key information

Conditions

Periodontitis Behavior Health Behavior Mouth Diseases Periodontal Diseases Smoking Cessation Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Smoking cessation therapy

Behavioral

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

Non-surgical periodontal therapy

Procedure

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

Primary outcomes

  1. Change in Clinical Attachment Level (millimeters) after 24 months

    Time frame: baseline and 24 months

Secondary outcomes

  1. Change in Gingival recession (millimeters) after 24 months

    Time frame: baseline and 24 months

  2. Change in Pocket depth (millimeters) after 24 months

    Time frame: baseline and 24 months

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

    Time frame: baseline and 24 months

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

    Time frame: baseline and 24 months

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Registry information

Acronym: EsCAPE

Important dates

Study start
2007
Primary completion
2014
Study completion
2014
First posted
Jul 9, 2015
Registry last updated
Apr 15, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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