Inverted Periosteal Flap vs Buccal Advancement Flap for Oroantral Communication Closure
2 juni 2026 uppdaterad av: 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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
24
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
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Damascus, Syrien
- School of Dental Medicine
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-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
Tar emot friska volontärer
Nej
Beskrivning
Inclusion Criteria:
- Presence of an oroantral communication (OAC) with a diameter between 3-7 mm.
- Communication resulting from extraction of posterior maxillary teeth (first molar, second molar, third molar, or second premolar).
- Recent perforation occurring no more than 48 hours prior to surgical intervention.
Exclusion Criteria:
- Presence of foreign bodies or residual tooth fragments within the maxillary sinus.
- Presence of systemic diseases that could impair wound healing (e.g., uncontrolled diabetes, immunosuppression).
- History of maxillary sinusitis prior to the perforation.
- Presence of periapical lesions or cysts at the extraction site.
- Smokers.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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.
|
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.
|
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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Successful Closure of Oroantral Communication
Tidsram: 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.
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1 week, 15 days, and 45 days after surgery.
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Postoperative Pain
Tidsram: 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
Tidsram: 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.
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Postoperative days 1, 3, and 5.
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Samarbetspartners
Utredare
- Studierektor: Saleh Al Kurdi, PhD, Arab International University
- Huvudutredare: Majd S Mohammad, DDs, Damascus University
- Studiestol: Omar A Heshmeh, PhD, Damascus University
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna publikationer
- Visscher SH, van Minnen B, Bos RR. Closure of oroantral communications: a review of the literature. J Oral Maxillofac Surg. 2010 Jun;68(6):1384-91. doi: 10.1016/j.joms.2009.07.044. Epub 2010 Mar 12. No abstract available.
- Parvini P, Obreja K, Begic A, Schwarz F, Becker J, Sader R, Salti L. Decision-making in closure of oroantral communication and fistula. Int J Implant Dent. 2019 Apr 1;5(1):13. doi: 10.1186/s40729-019-0165-7.
- Lago-Mendez L, Diniz-Freitas M, Senra-Rivera C, Gude-Sampedro F, Gandara Rey JM, Garcia-Garcia A. Relationships between surgical difficulty and postoperative pain in lower third molar extractions. J Oral Maxillofac Surg. 2007 May;65(5):979-83. doi: 10.1016/j.joms.2006.06.281.
- Rosenfeld EA. Inverted periosteal flap: an alternative to the buccal advancement flap for tension-free, watertight closure. J Oral Maxillofac Surg. 2014 Jul;72(7):1244-50. doi: 10.1016/j.joms.2014.03.006. Epub 2014 Mar 20.
- Ibrahim MT, Gharieb EA, Sheta MS. A pedicled buccal periosteal flap for the closure of oro-antral fistula. BMC Oral Health. 2024 Apr 10;24(1):440. doi: 10.1186/s12903-024-04217-6.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
15 september 2024
Primärt slutförande (Faktisk)
8 augusti 2025
Avslutad studie (Faktisk)
10 december 2025
Studieregistreringsdatum
Först inskickad
2 juni 2026
Först inskickad som uppfyllde QC-kriterierna
2 juni 2026
Första postat (Faktisk)
5 juni 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
5 juni 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
2 juni 2026
Senast verifierad
1 juni 2026
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- DN-230426-776
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
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