- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT02744417
Effect of Smoking Cessation on Clinical and Microbiological Outcomes of the Non-surgical Periodontal Therapy (EsCAPE2)
Studie Overzicht
Toestand
Conditie
Gedetailleerde beschrijving
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).
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
---|---|
Experimenteel: 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)
Andere namen:
bupropion hydrochloride 150mg
Andere namen:
Varenicline 0,5mg
Andere namen:
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Change in Clinical Attachment Level
Tijdsspanne: baseline - 12 months
|
Change in Clinical Attachment Level (millimeters) after 12 months
|
baseline - 12 months
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Change in Gingival recession
Tijdsspanne: baseline - 12 months
|
Change in Gingival recession (millimeters) after 12 months
|
baseline - 12 months
|
Change in Pocket depth
Tijdsspanne: baseline - 12 months
|
Change in Pocket depth (millimeters) after 12 months
|
baseline - 12 months
|
Change in bleeding on probing
Tijdsspanne: baseline - 12 months
|
Change in bleeding on probing (percentage of sites with bleeding) after 12 months
|
baseline - 12 months
|
Change in visible plaque
Tijdsspanne: 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
Tijdsspanne: baseline - 12 months
|
Prevalence and levels of Aggregatibacter actinomycetemcomitans determined by means of (RT-PCR).
|
baseline - 12 months
|
Prevalence and levels of Porphyromonas gingivalis
Tijdsspanne: baseline - 12 months
|
Prevalence and levels of Porphyromonas gingivalis, determined by means of (RT-PCR).
|
baseline - 12 months
|
Prevalence and levels of Tannerella forsythia
Tijdsspanne: baseline - 12 months
|
Prevalence and levels of Tanerella forsythia, determined by means of RT-PCR
|
baseline - 12 months
|
Prevalence and levels of Treponema denticola
Tijdsspanne: baseline - 12 months
|
Prevalence and levels of Treponema denticola, determined by means of RT-PCR
|
baseline - 12 months
|
Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Claudio M Pannuti, PhD, University of Sao Paulo
Publicaties en nuttige links
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
- Stomatognatische ziekten
- Parodontale aandoeningen
- Mondziekten
- Parodontitis
- Fysiologische effecten van medicijnen
- Neurotransmitter agenten
- Moleculaire mechanismen van farmacologische werking
- Autonome agenten
- Agenten van het perifere zenuwstelsel
- Cholinerge middelen
- Enzymremmers
- Psychotrope medicijnen
- Neurotransmitter-opnameremmers
- Membraantransportmodulatoren
- Antidepressiva
- Dopamine-agenten
- Cytochroom P-450 enzymremmers
- Ganglionische stimulerende middelen
- Nicotine-agonisten
- Cholinerge agonisten
- Antidepressiva, tweede generatie
- Cytochroom P-450 CYP2D6-remmers
- Dopamine-opnameremmers
- Nicotine
- Bupropion
- Varenicline
Andere studie-ID-nummers
- EsCAPE2
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
Klinische onderzoeken op Parodontitis
-
Government College of Dentistry, IndoreOnbekend
-
Institute of Dental Sciences, Bareilly, Uttar Pradesh...OnbekendCHRONISCHE PERIODONTITIS
-
Postgraduate Institute of Dental Sciences RohtakVoltooidOsteopenie | PERIODONTITIS
Klinische onderzoeken op Smoking cessation counseling
-
Vanderbilt-Ingram Cancer CenterNational Cancer Institute (NCI); National Institutes of Health (NIH)Actief, niet wervend