- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT03631498
Apoptotic Changes in Gingiva Caused by Smoking
15. august 2018 oppdatert av: Hatice Balci Yuce, Tokat Gaziosmanpasa University
Apoptosis and Tissue Destruction in Gingival Tissues of Smoker and Non-smoker Periodontitis Patients
Smoking is a major environmental risk factor associated with common forms of human chronic periodontitis.
The aim of the present study was to evaluate apoptotic tissue alterations and tissue destruction in smoker and non-smoker chronic periodontitis patients and healthy individuals.
The investigators of the study suggest that smoking decrease tissue quality and increase inflammation level in gingival tissues in both healthy individuals and periodontitis patients.
One possible mechanism for this is suggested to be increased apoptosis.
Studieoversikt
Status
Fullført
Forhold
Detaljert beskrivelse
Periodontal disease disrupts soft tissue metabolism in the gingiva through a decrease in the production of collagen, the quality, and quantity of the connective tissue.
The etiology and pathogenesis of chronic periodontitis are mostly revealed, however, the mechanism of environmental factors such as smoking yet to be clarified.
Major consequences of smoking in gingival tissues are suggested to be the reduction in neutrophil and fibroblast function, decreased immunoglobulin G production, increased periodontal pathogen bacteria prevalence, difficulty in eliminating pathogens with mechanical therapy, and reduction in growth factor production.
In the present study, markers of tissue destruction, matrix metalloproteinase-8 and tissue inhibitor of matrix metalloproteinase-1, hypoxia markers, vascular endothelial growth factor and hypoxia-inducible factor and apoptotic markers, bax, bcl-2, and caspase-3 were evaluated.
Studietype
Observasjonsmessig
Registrering (Faktiske)
60
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Tokat, Tyrkia, 60100
- Gaziosmanpasa University Faculty of Dentistry
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
30 år til 50 år (Voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Alle
Prøvetakingsmetode
Sannsynlighetsprøve
Studiepopulasjon
Healthy individuals who were either smokers or non-smokers, chronic periodontitis patients who were either smokers or non-smokers older than 30 years old and younger than 50 years old were enrolled.
The age was specifically chosen because aging changes periodontal and gingival tissues independently of other variables.
Any possible factor which might alter connective tissue metabolism were excluded.
Beskrivelse
Inclusion Criteria:
- Age range from 30 to 45,
- the existence of at least 20 functioning teeth,
- systemical health,
- no antibiotic use within 6 months,
- no periodontal therapy within 6 months,
- no pregnancy or lactation,
- no drug use, in addition; for the smokers existence of the smoking condition for at least five years.
Exclusion Criteria:
- Patients younger than 30 older than 50 years old,
- the absence of occlusion,
- drug use,
- pregnancy/lactation,
- previous antibiotic use,
- previous periodontal therapy,
- the existence of any systemical disease.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
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Healthy individuals
Gingival biopsies of healthy individuals who were never-smokers and had no systemic or oral disease or condition.
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periodontitis patients
Gingival biopsies of periodontitis patients who were never-smokers and had no systemic disease or condition.
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Healthy smokers
Gingival biopsies of healthy individuals who were smokers but no systemic or oral disease or condition.
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Smokers with periodontitis
Gingival biopsies of periodontitis patients who were smokers but no systemic disease or condition.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Fibroblaster og totalt antall inflammatoriske celler
Tidsramme: Biopsier ble tatt en dag etter innledende undersøkelser, histologisk analyse ble utført 2 uker etter.
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Fibroblast- og totale inflammatoriske celletall i gruppene ble bestemt i et standardisert 1000 mikrometer kvadratisk område med histomorfometrisk evaluering.
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Biopsier ble tatt en dag etter innledende undersøkelser, histologisk analyse ble utført 2 uker etter.
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Apoptotic markers
Tidsramme: Biopsies were obtained a day after initial examinations, histological analysis were performed 2 weeks after
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Apoptotic and anti-apoptotic proteins and enzymes related to apoptosis were evaluated via immunohistochemistry.
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Biopsies were obtained a day after initial examinations, histological analysis were performed 2 weeks after
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Hypoxia and tissue destruction markers
Tidsramme: Biopsies were obtained a day after initial examinations, histological analysis were performed 2 weeks after
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Vascular endothelial growth factor and hypoxia-inducible factor as hypoxia markers and matrix metalloproteinase and it inhibitor as destruction markers were evaluated via immunohistochemistry.
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Biopsies were obtained a day after initial examinations, histological analysis were performed 2 weeks after
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: HATİCE BALCI YÜCE, PhD, Gaziosmanpasa University
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
10. januar 2017
Primær fullføring (Faktiske)
10. januar 2018
Studiet fullført (Faktiske)
10. april 2018
Datoer for studieregistrering
Først innsendt
13. august 2018
Først innsendt som oppfylte QC-kriteriene
13. august 2018
Først lagt ut (Faktiske)
15. august 2018
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
16. august 2018
Siste oppdatering sendt inn som oppfylte QC-kriteriene
15. august 2018
Sist bekreftet
1. august 2018
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
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