The Impact of Cigarette Smoking on Periodontal Therapy
2. november 2021 opdateret af: University of Bergen
Outcomes of Periodontal Therapy in Smokers and Non-smokers With Chronic Periodontitis
Periodontitis patients, 40 cigarette smokers and 40 non-smokers (defined by cotinine measures in serum), were recruited to this double arm prospective cohort study.
Data were collected 3 months following non-surgical and surgical periodontal treatment, and following 12 months with supportive periodontal therapy.
Data collected were clinical attachment level, probing depth, bleeding on probing,oral bacteria, serum, blood (PAXgeneBlood), and gingival crevicular fluid.
Studieoversigt
Status
Afsluttet
Betingelser
Detaljeret beskrivelse
The overall aim of this work was to study clinical outcomes of active and supportive periodontal therapy in smokers and non-smokers with chronic periodontitis at patient, tooth, and site level. Moreover, to compare the periopathogenic microflora and inflammatory markers in gingival crevicular fluid and in blood in smokers and non-smokers following therapy.
Eighty patients, 40 smokers and 40 non-smokers, with moderate to severe chronic periodontitis were included in this prospective cohort study and treated non-surgically and surgically, and then followed-up in a supportive periodontal therapy program for 12 months. Smoking status was validated measuring serum cotinine levels at pre-treatment and 12 months following supportive periodontal therapy.
Clinical measurements included full mouth recordings of clinical attachment level, probing depth, bleeding on probing, and plaque index at pre-treatment and following active and supportive periodontal therapy. At the same timepoints, subgingival plaque samples of 20 subgingival periopathogenic bacterial species were analysed using checkerboard DNA-DNA hybridization. Blood samples (PAXgeneBlood), serum, gingval crevicular fluid were also collected at the three timepoints.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
80
Fase
- Ikke anvendelig
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
35 år til 75 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- healthy subjects
- age 35-75 years
- diagnosed with chronic periodontitis
- at least four non-adjacent teeth with proximal sites with a PD ≥6 mm and clinical attachment loss ≥5 mm with BoP and no radiographic signs of apical pathology.
- either smokers (>10 cigarettes per day for at least 5 years) or non-smokers (never smoked or not within the last 5 years).
Exclusion Criteria:
- subjects who presented with any current medical condition or used medications known to affect periodontal healing
- incorrectly reported smoking status
- use of antibiotics within 6 months of the study
- received subgingival scaling within 6 months of the study
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: Cigarette smokers with periodontitis
Periodontal therapy in cigarette smokers
|
Non-surgical and surgical periodontal therapy in cigarette smokers and non-smokers
Andre navne:
|
|
Aktiv komparator: Non-smokers with periodontitis
Periodontal therapy in non-smokers
|
Non-surgical and surgical periodontal therapy in cigarette smokers and non-smokers
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
PD ≥5 mm with BoP
Tidsramme: 24 months
|
Corrected for clustering within patients, teeth, and sites over time, was the unit of the analysis and PD ≥5 mm with BoP was the outcome (dependent variable) dichotomized as present (1) or absent (0).
|
24 months
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Teeth present
Tidsramme: 24 months
|
Number of teeth
|
24 months
|
|
Clinical periodontal attachmentloss
Tidsramme: 24 months
|
Clinical attachment loss in mm
|
24 months
|
|
Periodontal pocket depth
Tidsramme: 24 months
|
Probing depth in mm
|
24 months
|
|
Bleeding at site level
Tidsramme: 24 months
|
Bleeding on probing (yes or no)
|
24 months
|
|
Bleeding at patient level
Tidsramme: 24 months
|
Bleeding index in percentage (%)
|
24 months
|
|
Plaque at patient level
Tidsramme: 24 months
|
Plaque index in percentage (%)
|
24 months
|
|
Amount of periopathogenic bacteria
Tidsramme: 24 months
|
Subgingival plaque samples of 20 subgingival periopathogenic bacterial species were analysed using checkerboard DNA-DNA hybridization.
|
24 months
|
|
Inflammatory gingival crevicular fluid markers (proteins)
Tidsramme: 24 months
|
Concentrations of gingival crevicular fluid biomarkers measured in pg/mLwere analysed using multiplex and singleplex micro-bed immunoassays.
|
24 months
|
|
Serum proteins
Tidsramme: 24 months
|
Concentration of inflammatory serum markers measured in pg/ɥL determined using multiplex kit Bio-Plex Human ProTM Assay.
|
24 months
|
|
Gene expression in blood
Tidsramme: 24 months
|
Inflammatory gene (RNA) expression levels is estimated by counting the reads that map to genes or exones using the the RPKM (Reads per Kilobases per Million reads) methods.
|
24 months
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Dagmar F. Bunæs, PhD, Department of Clinical Dentistry - Periodontics, University of Bergen, NORWAY
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- Bunaes DF, Lie SA, Enersen M, Aastrom AN, Mustafa K, Leknes KN. Site-specific treatment outcome in smokers following non-surgical and surgical periodontal therapy. J Clin Periodontol. 2015 Oct;42(10):933-42. doi: 10.1111/jcpe.12462. Epub 2015 Oct 28.
- Bunaes DF, Mustafa M, Mohamed HG, Lie SA, Leknes KN. The effect of smoking on inflammatory and bone remodeling markers in gingival crevicular fluid and subgingival microbiota following periodontal therapy. J Periodontal Res. 2017 Aug;52(4):713-724. doi: 10.1111/jre.12438. Epub 2017 Mar 17.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
1. april 2012
Primær færdiggørelse (Faktiske)
1. marts 2015
Studieafslutning (Faktiske)
1. marts 2015
Datoer for studieregistrering
Først indsendt
5. oktober 2021
Først indsendt, der opfyldte QC-kriterier
2. november 2021
Først opslået (Faktiske)
15. november 2021
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
15. november 2021
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
2. november 2021
Sidst verificeret
1. november 2021
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 94605
Plan for individuelle deltagerdata (IPD)
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Ingen
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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Ingen
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