Skip to main content
OpenTrials
Completed

NCT Number: NCT07630701

Inverted Periosteal Flap vs Buccal Advancement Flap for Oroantral Communication Closure

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Oroantral Communication Fistula Mouth Diseases Oral Fistula Oroantral Fistula Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Stomatognathic Diseases

Age range

24 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

School of Dental Medicine

Damascus, Syria

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Inverted Buccal Periosteal Flap

Procedure

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.

Buccal Advancement Flap

Procedure

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.

Primary outcomes

  1. Successful Closure of Oroantral Communication

    Time frame: 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.

Secondary outcomes

  1. Postoperative Pain

    Time frame: 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.

  2. Postoperative Facial Edema

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Arab International University

Other

Collaborators

  • Damascus University

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jun 5, 2026
Registry last updated
Jun 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.