- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01246596
Chronic Presence of Epstein Barr Virus in Epithelial Cells From Gingiva is Associated With Periodontitis
17. december 2012 opdateret af: Centre Hospitalier Universitaire de Nice
The etiopathogenesis of periodontal disease results from complex interaction between infectious agents, mainly including bacteria, and host cellular and humoral immune responses.
However it is thought that bacteria-induced pathogenesis is not sufficient alone to explain all biological and clinical features of the destructive periodontal disease.
The main hypothesis is that herpesviruses, such as Epstein-Barr Virus, may participate as well by altering epithelial gingival cell biology and consequently may promote the initiation and progression of periodontitis.
Studieoversigt
Status
Ukendt
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Forventet)
30
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
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Nice, Frankrig, 0600
- Rekruttering
- Dr Severine VINCENT
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Kontakt:
- Severine VINCENT, PH
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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
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- 10 patients affected by chronic periodontitis
- 10 patients affected by aggressive periodontitis
- 10 healthy patients (orthodontics extraction)
- Subject who have read and understood the information note relative under investigation and who have signed the informed consent
- major patient
Exclusion Criteria:
- Patient with no contre-indication to periodontal treatment
- Patient with serious blood disease
- Patient who exhibits systemic condition incompatible with realization of the study
- Patient treated with oral retinoids, bisphosphonates, oral anticoagulants and anticonvulsivants
- Patient who presents a buccal carcinoma treated with radiotherapy
- Patient who have received during the past 6 months: anti-inflammatory drugs, anti-cancerous or immunosuppressive chemiotherapy
- Patient who presents a linguistic or psychic incapacity to understand information
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Sundhedstjenesteforskning
- Tildeling: Ikke-randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Aktiv komparator: kronisk paradentose
|
The objective of root planing, otherwise known as conventional periodontal therapy, non-surgical periodontal therapy, or dental prophylaxis is to remove or eliminate the etiologic agents which cause inflammation: dental plaque, its products and calculus,[1] thus helping to establish a periodontium that is free of disease.[2]
The objective of root planing, otherwise known as conventional periodontal therapy, non-surgical periodontal therapy, or dental prophylaxis is to remove or eliminate the etiologic agents which cause inflammation: dental plaque, its products and calculus, thus helping to establish a periodontium that is free of disease.
|
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Aktiv komparator: aggressive periodontitis
|
The objective of root planing, otherwise known as conventional periodontal therapy, non-surgical periodontal therapy, or dental prophylaxis is to remove or eliminate the etiologic agents which cause inflammation: dental plaque, its products and calculus,[1] thus helping to establish a periodontium that is free of disease.[2]
The objective of root planing, otherwise known as conventional periodontal therapy, non-surgical periodontal therapy, or dental prophylaxis is to remove or eliminate the etiologic agents which cause inflammation: dental plaque, its products and calculus, thus helping to establish a periodontium that is free of disease.
|
|
Aktiv komparator: healthy patient (orthodontics extraction)
|
The objective of root planing, otherwise known as conventional periodontal therapy, non-surgical periodontal therapy, or dental prophylaxis is to remove or eliminate the etiologic agents which cause inflammation: dental plaque, its products and calculus,[1] thus helping to establish a periodontium that is free of disease.[2]
The objective of root planing, otherwise known as conventional periodontal therapy, non-surgical periodontal therapy, or dental prophylaxis is to remove or eliminate the etiologic agents which cause inflammation: dental plaque, its products and calculus, thus helping to establish a periodontium that is free of disease.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Percentage of gingival epithelial cells infected by EBV (by immunofluorescence and In situ Hybridization)
Tidsramme: at time=0
|
at time=0
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Epithelial tissue infected by EBV (by immunofluorescence and in situ hybridization)
Tidsramme: at time = 0
|
at time = 0
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Presence / absence of latency and / or lytic proteins (by immunofluorescence and in situ hybridization)
Tidsramme: at time = 0
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at time = 0
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Ledende efterforsker: Severine VINCENT, PH, CHU de Nice Hôpital Saint Roch
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
1. januar 2011
Primær færdiggørelse (Faktiske)
1. juni 2011
Studieafslutning (Forventet)
1. januar 2014
Datoer for studieregistrering
Først indsendt
17. november 2010
Først indsendt, der opfyldte QC-kriterier
22. november 2010
Først opslået (Skøn)
23. november 2010
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
18. december 2012
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
17. december 2012
Sidst verificeret
1. november 2010
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 10-AOI-01
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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Second Affiliated Hospital, School of Medicine,...Rekruttering
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Texas A&M UniversityAktiv, ikke rekrutterendeParadentose | Periodontal sygdomForenede Stater
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