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Inverted Periosteal Flap vs Buccal Advancement Flap for Oroantral Communication Closure

2. juni 2026 opdateret af: Arab International University

Comparison of Inverted Periosteal Flap Versus Buccal Advancement Flap for Closure of Post-Extraction Maxillary Sinus Perforation: A Randomized Controlled Trial

This randomized controlled clinical study will evaluate the effectiveness of the inverted buccal periosteal flap in closing recent post-extraction oroantral communications and compare it with the conventional buccal advancement flap. The study will include 24 patients who develop an oroantral communication measuring 3-6 mm after non-surgical extraction of maxillary posterior teeth. Participants will be randomly allocated into two groups: the test group treated with the inverted buccal periosteal flap, and the control group treated with the buccal advancement flap. The primary outcome will be successful clinical closure of the communication, assessed by absence of oroantral fistula, nasal fluid leakage, and air leakage during the Valsalva test. Secondary outcomes will include postoperative pain, facial edema. Patients will be followed for up to 45 days after surgery.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Oroantral communication is an abnormal connection between the oral cavity and the maxillary sinus, most commonly occurring after extraction of maxillary posterior teeth. If not closed properly, it may lead to oroantral fistula or maxillary sinus complications.

This randomized controlled clinical study will compare the inverted buccal periosteal flap with the conventional buccal advancement flap for closure of recent post-extraction oroantral communications. The study will include 24 patients with communications measuring 3-6 mm and diagnosed within 48 hours after non-surgical extraction.

Participants will be randomly divided into two groups. In the test group, closure will be performed using the inverted buccal periosteal flap, where the periosteal layer is dissected, inverted over the defect, and sutured to the palatal tissue without tension. In the control group, closure will be performed using the buccal advancement flap, where a buccal mucoperiosteal flap is advanced palatally and sutured to cover the communication.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

24

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Syrien
      • Damascus, Syrien
        • School of Dental Medicine

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

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

  1. Presence of an oroantral communication (OAC) with a diameter between 3-7 mm.
  2. Communication resulting from extraction of posterior maxillary teeth (first molar, second molar, third molar, or second premolar).
  3. Recent perforation occurring no more than 48 hours prior to surgical intervention.

Exclusion Criteria:

  1. Presence of foreign bodies or residual tooth fragments within the maxillary sinus.
  2. Presence of systemic diseases that could impair wound healing (e.g., uncontrolled diabetes, immunosuppression).
  3. History of maxillary sinusitis prior to the perforation.
  4. Presence of periapical lesions or cysts at the extraction site.
  5. Smokers.

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: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Inverted Buccal Periosteal Flap
Participants in this arm will receive surgical closure of the post-extraction oroantral communication using the inverted buccal periosteal flap. A full-thickness mucoperiosteal flap will be elevated, the periosteal layer will be dissected and inverted over the defect, then sutured to the palatal tissue to achieve tension-free closure.
Procedure: Inverted Buccal Periosteal Flap
Surgical closure of post-extraction oroantral communication using an inverted buccal periosteal flap. A full-thickness mucoperiosteal flap will be elevated, followed by dissection of the periosteal layer from the overlying mucosa. The periosteal flap will then be inverted over the defect and sutured to the palatal tissue to achieve tension-free closure.
Aktiv komparator: Buccal Advancement Flap
Participants in this arm will receive surgical closure of the post-extraction oroantral communication using the conventional buccal advancement flap. A buccal mucoperiosteal flap will be elevated, advanced palatally, and sutured to the palatal mucosa to cover the communication.
Procedure: Buccal Advancement Flap
Surgical closure of post-extraction oroantral communication using the conventional buccal advancement flap. A buccal full-thickness mucoperiosteal flap will be elevated, released by periosteal scoring, advanced palatally, and sutured to the palatal mucosa to cover the communication.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Successful Closure of Oroantral Communication
Tidsramme: 1 week, 15 days, and 45 days after surgery.
Successful closure will be assessed clinically by confirming the absence of oroantral fistula formation, absence of fluid leakage through the nose, and absence of air leakage or air bubbles during the Valsalva test.
1 week, 15 days, and 45 days after surgery.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Postoperative Pain
Tidsramme: Postoperative days 1, 3, 5, and 7.
Postoperative pain will be assessed using the Visual Analog Scale. The scale ranges from 0 to 10, where 0 indicates no pain and 10 indicates the worst possible pain. Higher scores indicate a worse outcome.
Postoperative days 1, 3, 5, and 7.
Postoperative Facial Edema
Tidsramme: Postoperative days 1, 3, and 5.
Facial edema will be assessed using extraoral linear measurements between fixed facial reference points. The measured distances will be used to estimate postoperative facial swelling and compare changes between the two study groups. Higher values indicate greater facial edema and therefore a worse outcome.
Postoperative days 1, 3, and 5.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Arab International University

Samarbejdspartnere

Damascus University

Efterforskere

  • Studieleder: Saleh Al Kurdi, PhD, Arab International University
  • Ledende efterforsker: Majd S Mohammad, DDs, Damascus University
  • Studiestol: Omar A Heshmeh, PhD, Damascus University

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

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)

15. september 2024

Primær færdiggørelse (Faktiske)

8. august 2025

Studieafslutning (Faktiske)

10. december 2025

Datoer for studieregistrering

Først indsendt

2. juni 2026

Først indsendt, der opfyldte QC-kriterier

2. juni 2026

Først opslået (Faktiske)

5. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

5. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

2. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • DN-230426-776

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

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Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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Kliniske forsøg med Oroantral kommunikation

Kliniske forsøg med Inverted Buccal Periosteal Flap

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