Effect of Smoking Cessation on Non-surgical Periodontal Therapy

Periodontitis Clinical Trial

— EsCAPE  

Official title:

Effect of Smoking Cessation on Non-surgical Periodontal Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02493270
• Other study ID #: EsCAPE
• Status: Completed
• Phase: N/A
• First received: July 2, 2015
• Last updated: April 13, 2016
• Start date: May 2007
• Est. completion date: June 2014

Study information

• Verified date: April 2016
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 177
• Est. completion date: June 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Periodontitis

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

References & Publications (2)

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 — View Citation

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.1 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Clinical Attachment Level (millimeters) after 24 months		baseline and 24 months	No
Secondary	Change in Gingival recession (millimeters) after 24 months		baseline and 24 months	No
Secondary	Change in Pocket depth (millimeters) after 24 months		baseline and 24 months	No
Secondary	Change in bleeding on probing (percentage of sites with bleeding) after 24 months		baseline and 24 months	No
Secondary	Change in visible plaque (percentage of sites with visible plaque) after 24 months		baseline and 24 months	No