Forsinket kirurgisk obturator efter mucormycosis Post COVID-19
20. august 2026 opdateret af: Mohammed El-Sawy, Menoufia University
Forsinket kirurgisk obturator som en behandlingsmulighed efter mucormycosis Post COVID-19: En prospektiv observationskohorteundersøgelse
Under COVID-19-pandemien var der mange rapporter om COVID-19-associerede slimhindetilfælde.
Håndtering af denne tilstand udgjorde en ny udfordring for klinikere.
Ledelsen omfatter terapeutiske lægemidler og aggressiv kirurgisk debridering.
På grund af sygdomsprognosens uforudsigelighed og det mulige tilbagefald af sygdommen er genoptræning med forsinkede kirurgiske obturatorer gavnlig for patienterne.
Derfor havde den aktuelle undersøgelse til formål at evaluere virkningen af forsinkede kirurgiske obturatorer på livskvaliteten for COVID-19-associerede mucormycosis-patienter efter maksillektomier
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Globalt varierede forekomsten af mucormycosis fra 0,005 til 1,7 pr. million indbyggere, mens dens udbredelse er næsten 80 gange højere (0,14 pr. 1000) i Indien sammenlignet med udviklede lande, i et nyligt estimat for år 2019-2020.
Blandt de medicinske fagfolk, der er involveret i håndteringen af patienter med mucormycosis, er kæbeproteser ansvarlige for proteserestaurering af tabte mund- og kæbestrukturer, og hjælper patienter med at socialisere og få en acceptabel livskvalitet efter kirurgisk behandling
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
42
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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-
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Al Mansurah, Egypten, 12345
- Mohammed A. El-Sawy
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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
- Voksen
- Ældre voksen
Tager imod sunde frivillige
N/A
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
Undersøgelsen vil blive udført på 60 patienter, der har gennemgået maxillectomies mellem 2020 og 2023.
Alle patienter på 25 år og derover, der gav samtykke til undersøgelsen, blev inkluderet.
Beskrivelse
Inklusionskriterier:
*Patienter, som har gennemgået partiel, subtotal og hemi-maxillektomi på grund af COVID-19-associeret mucormycosis, og som havde behov for proteserehabilitering med forsinket kirurgisk obturator.
Ekskluderingskriterier:
- Patienter, der er uvillige til undersøgelsen.
- Patienter, der gennemgik hvilke bilaterale maxillectomies.
- Patienter med omfattende tab af palatal slimhinde.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
|
Oral Neoplasm
Patients who underwent maxillectomy for oral neoplasms and subsequently received obturator prosthetic rehabilitation.
Eligible patients had Brown Class IIa, IIb, or IIc maxillary defects.
Patient records from the Prosthodontic Department were retrospectively reviewed.
OHIP-14 scores were recorded at four assessment time points: after surgical removal of the maxillary defect and before obturator rehabilitation, after insertion of the delayed surgical obturator, after insertion of the transitional obturator, and after insertion of the definitive obturator.
The Obturator Functioning Scale (OFS) was recorded only after prosthesis insertion and was therefore assessed at three time points: after the delayed surgical, transitional, and definitive obturators.
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Obturator prosthetic rehabilitation provided as part of routine clinical care following maxillectomy.
Rehabilitation progressed through delayed surgical, transitional, and definitive obturator stages according to clinical healing and tissue stabilization.
No intervention was assigned or modified for the purposes of this retrospective study.
|
|
COVID-19-Associated Mucormycosis (CAM)
Patients who underwent maxillectomy for COVID-19-associated mucormycosis (CAM) and subsequently received obturator prosthetic rehabilitation.
Eligible patients had Brown Class IIa, IIb, or IIc maxillary defects.
Patient records from the Prosthodontic Department were retrospectively reviewed.
OHIP-14 scores were recorded at four assessment time points: after surgical removal of the maxillary defect and before obturator rehabilitation, after insertion of the delayed surgical obturator, after insertion of the transitional obturator, and after insertion of the definitive obturator.
The Obturator Functioning Scale (OFS) was recorded only after prosthesis insertion and was therefore assessed at three time points: after the delayed surgical, transitional, and definitive obturators.
|
Obturator prosthetic rehabilitation provided as part of routine clinical care following maxillectomy.
Rehabilitation progressed through delayed surgical, transitional, and definitive obturator stages according to clinical healing and tissue stabilization.
No intervention was assigned or modified for the purposes of this retrospective study.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in Oral Health-Related Quality of Life (OHIP-14) Across Obturator Rehabilitation Stages
Tidsramme: From after maxillectomy and before obturator rehabilitation through 1 week after insertion of the definitive obturator; assessments were performed at T1 (before obturator rehabilitation), T2 (1 week after delayed surgical obturator insertion), T3 (1 week
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Oral health-related quality of life was assessed using the validated Arabic version of the Oral Health Impact Profile-14 (OHIP-14).
The total OHIP-14 score ranges from 0 to 56, with higher scores indicating poorer quality of life.
Scores were retrospectively recorded at four assessment time points: after maxillectomy and before obturator rehabilitation, after insertion of the delayed surgical obturator, after insertion of the transitional obturator, and after insertion of the definitive obturator.
Changes in OHIP-14 scores across rehabilitation stages were compared within and between the oral neoplasm and COVID-19-associated mucormycosis cohorts.
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From after maxillectomy and before obturator rehabilitation through 1 week after insertion of the definitive obturator; assessments were performed at T1 (before obturator rehabilitation), T2 (1 week after delayed surgical obturator insertion), T3 (1 week
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Obturator Functional Performance (Obturator Functioning Scale)
Tidsramme: From 1 week after insertion of the delayed surgical obturator through 1 week after insertion of the definitive obturator, with assessments at 1 week after insertion of the delayed surgical, transitional, and definitive obturators.
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Obturator-related functional performance was assessed using the 15-item Obturator Functioning Scale (OFS), evaluating patient-reported difficulties related to speech, eating, and prosthesis appearance.
The OFS was retrospectively recorded after insertion of the delayed surgical obturator, transitional obturator, and definitive obturator.
Changes in OFS scores across these rehabilitation stages were compared within and between the oral neoplasm and COVID-19-associated mucormycosis cohorts.
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From 1 week after insertion of the delayed surgical obturator through 1 week after insertion of the definitive obturator, with assessments at 1 week after insertion of the delayed surgical, transitional, and definitive obturators.
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Mohammed A. El-Sawy, PhD, Menoufia University
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. juni 2024
Primær færdiggørelse (Faktiske)
20. september 2024
Studieafslutning (Faktiske)
30. november 2024
Datoer for studieregistrering
Først indsendt
21. juli 2024
Først indsendt, der opfyldte QC-kriterier
21. juli 2024
Først opslået (Faktiske)
23. juli 2024
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
25. august 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
20. august 2026
Sidst verificeret
1. august 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- ADMNF-0020424
Plan for individuelle deltagerdata (IPD)
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IPD-planbeskrivelse
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