- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02493270
Effect of Smoking Cessation on Non-surgical Periodontal Therapy (EsCAPE)
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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: Adjunctive smoking cessation
non-surgical periodontal therapy and concurrent 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
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
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Change in Clinical Attachment Level (millimeters) after 24 months
Tidsramme: baseline and 24 months
|
baseline and 24 months
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Change in Gingival recession (millimeters) after 24 months
Tidsramme: baseline and 24 months
|
baseline and 24 months
|
Change in Pocket depth (millimeters) after 24 months
Tidsramme: baseline and 24 months
|
baseline and 24 months
|
Change in bleeding on probing (percentage of sites with bleeding) after 24 months
Tidsramme: baseline and 24 months
|
baseline and 24 months
|
Change in visible plaque (percentage of sites with visible plaque) after 24 months
Tidsramme: baseline and 24 months
|
baseline and 24 months
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Claudio M Pannuti, PhD, University of Sao Paulo
Publikationer og nyttige links
Generelle publikationer
- 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.
- 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.
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- Escape
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Kliniske forsøg med Smoking cessation therapy
-
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-
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-
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Kristin AshfordNational Institute on Drug Abuse (NIDA)Afsluttet
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M.D. Anderson Cancer CenterNational Cancer Institute (NCI); National Institutes of Health (NIH)Rekruttering
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Douglas MenninWeill Medical College of Cornell University; Kent State UniversityAfsluttetGeneraliseret angstlidelse | Depression, angst | Angstlidelser og symptomer | Følelsesmæssig dysfunktionForenede Stater
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National University Hospital, SingaporeNational University, Singapore; Agency for Science, Technology and ResearchAfsluttet
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University of PennsylvaniaAfsluttetTilbagevendende Clostridium Difficile-infektionForenede Stater
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Medical College of WisconsinAktiv, ikke rekrutterendeProstatakræftForenede Stater
-
Dana-Farber Cancer InstituteAfsluttet