- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT02744417
Effect of Smoking Cessation on Clinical and Microbiological Outcomes of the Non-surgical Periodontal Therapy (EsCAPE2)
Studieöversikt
Status
Betingelser
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
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
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
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:
bupropion hydrochloride 150mg
Andra namn:
Varenicline 0,5mg
Andra namn:
|
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
Sponsor
Utredare
- Huvudutredare: Claudio M Pannuti, PhD, University of Sao Paulo
Publikationer och användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Stomatogena sjukdomar
- Parodontala sjukdomar
- Munsjukdomar
- Parodontit
- Läkemedels fysiologiska effekter
- Neurotransmittormedel
- Molekylära mekanismer för farmakologisk verkan
- Autonoma agenter
- Agenter från det perifera nervsystemet
- Kolinerga medel
- Enzyminhibitorer
- Psykotropa droger
- Neurotransmittorupptagshämmare
- Membrantransportmodulatorer
- Antidepressiva medel
- Dopaminmedel
- Cytokrom P-450 enzymhämmare
- Ganglionstimulerande medel
- Nikotinagonister
- Kolinerga agonister
- Antidepressiva medel, andra generationen
- Cytokrom P-450 CYP2D6-hämmare
- Dopaminupptagshämmare
- Nikotin
- Bupropion
- Vareniklin
Andra studie-ID-nummer
- EsCAPE2
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
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