- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT05344222
Effekter af fotobiomodulationskonditionering i påvirkede tredje molarer
Effekter af fotobiomodulationskonditionering af orofacialt væv i kirurgi til fjernelse af påvirkede mandibular tredje molarer: Randomiseret, sham-kontrolleret, dobbeltblindet klinisk forsøg
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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São Paulo, Brasilien, 01504-001
- University of Nove de Julho (UNINOVE)
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inklusionskriterier:
- mandlige og kvindelige voksne (18 år eller ældre)
- ingen tumorer i den orale region,
- ikke har gennemgået psykiatrisk behandling i det foregående år,
- et godt generelt helbred,
- tilfredsstillende mundhygiejne,
- angrebet mandibular tredje molar
- underskrevet erklæring om informeret samtykke.
Ekskluderingskriterier:
- sædvanlig brug af smertestillende eller antiinflammatorisk medicin til andre følgesygdomme,
- gennemgår neurologisk/psykiatrisk behandling,
- tænder med læsioner, der skal behandles i samme halvbue som den tand, der skal fjernes,
- systemisk sygdom,
- nuværende rygevane,
- pericoronitis i de foregående 30 dage,
- gravide eller ammende kvinder,
- dårlig mundhygiejne,
- lysfølsomhedsforstyrrelse,
- tumor i den orale region,
- hjerte sygdom,
- diabetes,
- bloddyskrasi,
- kemisk afhængighed,
- allergi over for medicin brugt i undersøgelsen,
- ankylose af kæbeleddet
- intraoperative komplikationer med operationstid på over 90 minutter.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: FOREBYGGELSE
- Tildeling: TILFÆLDIGT
- Interventionel model: PARALLEL
- Maskning: TRIPLE
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
EKSPERIMENTEL: Fotobiomodulation
Deltagerne i den aktive fotobiomodulationsgruppe vil blive bestrålet med infrarød LED ved en bølgelængde på 850 nm vinkelret på overfladen af huden i blid stationær kontakt på tre ekstraorale punkter.
Behandlingen vil blive givet en time før det kirurgiske indgreb samt 48 timer og syv dage (fjernelse af suturer) efter den første bestråling.
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Deltagerne i den aktive fotobiomodulationsgruppe vil blive bestrålet med infrarød LED ved en bølgelængde på 850 nm vinkelret på overfladen af huden i blid stationær kontakt på tre ekstraorale punkter.
Behandlingen vil blive givet en time før det kirurgiske indgreb samt 48 timer og syv dage (fjernelse af suturer) efter den første bestråling.
|
SHAM_COMPARATOR: Sham fotobiomodulation
Til deltagerne i den falske gruppe vil der blive brugt et apparat med et lignende udseende, som ikke udsendte stråling.
Behandlingen vil blive givet en time før det kirurgiske indgreb samt 48 timer og syv dage (fjernelse af suturer) efter den første bestråling.
|
Til deltagerne i den falske gruppe vil der blive brugt et apparat med et lignende udseende, som ikke udsendte stråling.
Behandlingen vil blive givet en time før det kirurgiske indgreb samt 48 timer og syv dage (fjernelse af suturer) efter den første bestråling.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Infrarød LED.
Tidsramme: Gennemsnitligt 48 efter studieafslutning
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I den umiddelbare periode før operationen blev der taget tre målinger på patientens ansigt med en tidligere steriliseret fleksibel metrisk tape (centimeter): tragus - pogonion; tragus - læbekommissur; og underkæbevinkel - ydre orbikulær kommissur.
Mundåbningsområdet blev målt (centimeter) med steriliserede manuelle skydelære mellem den incisale kant af den maksillære og underkæbens centrale fortænder. Den visuelle analoge skala blev brugt til måling af smerteintensitet.
Hver patient markerede et punkt langs en linje mellem to yderpunkter nummereret nul (ingen smerte) til 10 (værst mulig smerte) for at repræsentere den smerte, der føltes i evalueringsøjeblikket (69,70).
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Gennemsnitligt 48 efter studieafslutning
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Infrarød LED - lignende enhed
Tidsramme: Gennemsnitligt 48 efter studieafslutning
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I den umiddelbare periode før operationen blev der taget tre målinger på patientens ansigt med en tidligere steriliseret fleksibel metrisk tape (centimeter): tragus - pogonion; tragus - læbekommissur; og underkæbevinkel - ydre orbikulær kommissur. Mundåbningsområdet blev målt (centimeter) med steriliserede manuelle skydelære mellem den incisale kant af de maksillære og centrale fortænder under underkæben. Den visuelle analoge skala blev brugt til måling af smerteintensitet. Hver patient markerede et punkt langs en linje mellem to yderpunkter nummereret nul (fravær af smerte) til 10 (værst tænkelige smerte) for at repræsentere smerten, der føltes i evalueringsøjeblikket (69,70). |
Gennemsnitligt 48 efter studieafslutning
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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: ERIKA MELLO, University of Nove de Julho
Publikationer og nyttige links
Generelle publikationer
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Hjælpsomme links
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Datoer for undersøgelser
Studer store datoer
Studiestart (FAKTISKE)
Primær færdiggørelse (FAKTISKE)
Studieafslutning (FAKTISKE)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (FAKTISKE)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (FAKTISKE)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
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Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
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Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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 .
Kliniske forsøg med Infrarød LED
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University of AthensRekrutteringCOVID-19 lungebetændelse | COVID-19 Akut Respiratorisk Distress SyndromeGrækenland
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Universidade Estadual de LondrinaAfsluttet
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VA Office of Research and DevelopmentAktiv, ikke rekrutterendeTraumatisk hjerneskade | Post traumatisk stress syndromForenede Stater
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University of Nove de JulhoUkendtTemporomandibulær lidelseBrasilien
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Federal University of Health Science of Porto AlegreAfsluttetAldring | Rynker
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New York Institute of TechnologyRekrutteringSmerte, kronisk | Ehlers-Danlos syndromForenede Stater
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Ensol BioscienceAfsluttet
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Universidade Norte do ParanáUniversidade Estadual de MaringáAfsluttetLændesmerter | Hydroterapi | Anstrengelse; OverskydendeBrasilien
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University of BergenGlamoxAfsluttetSøvn | Søvnmangel | Skift-arbejde-relateret søvnforstyrrelseNorge