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Effect of Smoking Cessation on Clinical and Microbiological Outcomes of the Non-surgical Periodontal Therapy (EsCAPE2)

3 november 2018 uppdaterad av: Claudio Mendes Pannuti
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).

Studieöversikt

Detaljerad beskrivning

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).

Studietyp

Interventionell

Inskrivning (Faktisk)

63

Fas

  • Inte tillämpbar

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: N/A
  • Interventionsmodell: Enskild gruppuppgift
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Smoking cessation therapy
Non-surgical periodontal therapy and concurrent smoking cessation therapy, with Smoking cessation counseling, Nicotine replacement therapy, use of bupropion hydrochloride and varenicline
Multidisciplinary smoking cessation counseling, performed by a team comprising physicians, nurses, a psychologist and dentists. It consisted of four 1-h counselling lectures delivered by physicians, psychologist-assisted cognitive behavioural therapy, and counseling provided by dentists during the active phase of the treatment and maintenance session, using motivational interviewing techniques
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
Nicotine replacement therapy: chewing gum (Nicorette chewing gum 2-4mg) and patches (Nicorette patches 15-25mg)
Andra namn:
  • Nicorette
bupropion hydrochloride 150mg
Andra namn:
  • Zyban
Varenicline 0,5mg
Andra namn:
  • Champix

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change in Clinical Attachment Level
Tidsram: baseline - 12 months
Change in Clinical Attachment Level (millimeters) after 12 months
baseline - 12 months

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change in Gingival recession
Tidsram: baseline - 12 months
Change in Gingival recession (millimeters) after 12 months
baseline - 12 months
Change in Pocket depth
Tidsram: baseline - 12 months
Change in Pocket depth (millimeters) after 12 months
baseline - 12 months
Change in bleeding on probing
Tidsram: baseline - 12 months
Change in bleeding on probing (percentage of sites with bleeding) after 12 months
baseline - 12 months
Change in visible plaque
Tidsram: baseline - 12 months
Change in visible plaque (percentage of sites with visible plaque) after 12 months
baseline - 12 months
Prevalence and levels of Aggregatibacter actinomycetemcomitans
Tidsram: baseline - 12 months
Prevalence and levels of Aggregatibacter actinomycetemcomitans determined by means of (RT-PCR).
baseline - 12 months
Prevalence and levels of Porphyromonas gingivalis
Tidsram: baseline - 12 months
Prevalence and levels of Porphyromonas gingivalis, determined by means of (RT-PCR).
baseline - 12 months
Prevalence and levels of Tannerella forsythia
Tidsram: baseline - 12 months
Prevalence and levels of Tanerella forsythia, determined by means of RT-PCR
baseline - 12 months
Prevalence and levels of Treponema denticola
Tidsram: baseline - 12 months
Prevalence and levels of Treponema denticola, determined by means of RT-PCR
baseline - 12 months

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Utredare

  • Huvudutredare: Claudio M Pannuti, PhD, University of Sao Paulo

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 augusti 2010

Primärt slutförande (Faktisk)

1 februari 2014

Avslutad studie (Faktisk)

1 mars 2014

Studieregistreringsdatum

Först inskickad

13 april 2016

Först inskickad som uppfyllde QC-kriterierna

15 april 2016

Första postat (Uppskatta)

20 april 2016

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

6 november 2018

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

3 november 2018

Senast verifierad

1 november 2018

Mer information

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

Kliniska prövningar på Smoking cessation counseling

3
Prenumerera