Acute Oroantral CommunicationNCT07884331
Buccal Periosteal Inversion Flap vs Buccal Advancement Flap for Acute Oro-Antral Communication Closure
A study testing Buccal Periosteal Inversion Flap and Buccal Advancement Flap in people with Acute Oroantral Communication, run by Medical University of Graz at 1 site in Austria.
Trial summary
This prospective randomized controlled clinical trial will compare the Buccal Periosteal Inversion Flap (BUPI) with the Buccal Advancement Flap (BAF) for the primary surgical closure of acute oro-antral communications (OAC) following tooth extraction in the posterior maxilla. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Oroantral Communication
- What is being tested?
- Buccal Periosteal Inversion Flap and Buccal Advancement Flap
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteAustria
- Study dates
- Oct 2026to Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Acute Oro-Antral Communication following extraction of posterior maxillary teeth (premolars and molars) within the last 24 hours
- Good general health
- Willingness to attend all scheduled follow-up examinations
Who cannot join
- Age < 18 years
- Acute inflammation or maxillary sinusitis
- Absence of nasal drainage during maxillary sinus irrigation
- Previous surgeries in the study area resulting in scarring
- Systemic diseases that could impair wound healing (e.g. uncontrolled diabetes mellitus)
- Immunosuppression
Show all 12Show fewer
- Diagnosed or previously treated neoplasms
- Bisphosphonate or antiresorptive therapy
- Pregnancy or breastfeeding
- Allergy to dexibuprofen
- Nicotine consumption ≥10 cigarettes/day
- Inability to give informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Austria1 site
Medical University of Graz, Department of Dental Medicine and Oral Health
Graz, Styria, 8043
Alen Saracevic, +43-688-64905288, alen.saracevic@stud.medunigraz.at
About this study
Official title: Comparison of the Buccal Periosteal Inversion Flap and Buccal Advancement Flap for the Closure of Acute Oro-Antral Communications: A Prospective Randomized Controlled Clinical Trial
This prospective randomized controlled clinical trial will compare the Buccal Periosteal Inversion Flap (BUPI) with the Buccal Advancement Flap (BAF) for the primary surgical closure of acute oro-antral communications (OAC) following tooth extraction in the posterior maxilla.
The primary objective is to determine whether the BUPI technique results in better preservation of keratinized gingival width compared with the BAF technique three months after surgery.
Read more
Secondary outcomes include successful closure rate of OACs, postoperative pain, swelling and bleeding, wound dehiscence or recurrence of the OAC, postoperative sinusitis or infection, reoperation rate, and operating time.
Participants will be randomly allocated in a 1:1 ratio to either BUPI or BAF. Clinical examinations and intraoral scans will be performed before surgery and at follow-up visits after 14 days, one month, and three months.
Read the detailed description
An OAC is a pathological communication between the oral cavity and the maxillary sinus and occurs most commonly following extraction of posterior maxillary teeth. Surgical closure is indicated to reduce the risk of maxillary sinusitis.
The Buccal Advancement Flap (BAF) is an established technique for primary closure of acute OACs. However, advancement of the buccal soft tissue results often in a reduction of keratinized gingival width and flattening of the oral vestibule, which may negatively affect subsequent prosthetic or implant treatment.
The Buccal Periosteal Inversion Flap (BUPI) is an alternative technique in which the periosteal layer of a buccal mucoperiosteal flap is separated from the overlying mucosa and inverted to cover the OAC. The overlying mucosa can therefore remain largely in its original position.
The study will prospectively compare both surgical techniques in adult participants presenting with an acute OAC following tooth extraction in the posterior maxilla.
After confirmation of eligibility and written informed consent, participants will undergo a baseline intraoral scan of the relevant quadrant and Periodontal Screening and Recording (PSR) of the relevant sextant. Participants will subsequently be randomized in a 1:1 ratio to BUPI or BAF using the Medical University of Graz randomization system.
The primary endpoint is the change in keratinized gingival width between baseline and three months after surgery. Keratinized gingival width will be measured between the mucogingival junction and the midpoint of the alveolar ridge using digital intraoral scans obtained with a 3Shape TRIOS 6 intraoral scanner. Measurements will be performed using 3D Slicer software.
Participants will document postoperative pain, swelling, and bleeding using a visual analog scale ranging from 0 to 10 on the day of surgery and for the subsequent seven postoperative days.
Clinical follow-up examinations will be performed after 14 days, one month, and three months.
- Conditions
- Acute Oroantral Communication
- Being tested
- Buccal Periosteal Inversion Flap, Buccal Advancement Flap
- Keywords
- Oro-antral communication, Oroantral communication, Oro-antral fistula, Maxillary sinus, Tooth extraction, Buccal advancement flap, Rehrmann flap, Buccal periosteal inversion flap, BUPI, Keratinized gingiva, Oral surgery, Maxillofacial surgery, Surgical closure, Oroantral fistula, OAC, BAF, Oro-antral communication closure, Posterior maxilla, Keratinized gingival width, Attached gingiva
- Medical subject headings
- Oroantral Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Buccal Periosteal Inversion FlapProcedure or surgery
Also called BUPI, Inverted Periosteal Flap, Buccal Periosteal Flap
Following elevation of a trapezoidal buccal mucoperiosteal flap, the periosteum is dissected from the overlying buccal mucosa from apical to coronal. The mobilized periosteal layer is inverted over the oro-antral communication and sutured to the palatal soft tissue to achieve tension-free closure, while the overlying buccal mucosa is largely maintained in its original position.
Buccal Advancement FlapProcedure or surgery
Also called BAF, Rehrmann Flap, Rehrmann Plastic
Following elevation of a trapezoidal buccal mucoperiosteal flap, the periosteum is incised to allow mobilization of the flap. The entire mucoperiosteal flap is advanced over the oro-antral communication to the palatal soft tissue to achieve tension-free primary closure.
| Study group | Role | What they receive |
|---|---|---|
| Buccal Periosteal Inversion Flap | Experimental | Participants assigned to this group will undergo surgical closure of the acute oro-antral communication using the Buccal Periosteal Inversion Flap. Receives: Procedure: Buccal Periosteal Inversion Flap |
| Buccal Advancement Flap | Active comparator | Participants assigned to this group will undergo surgical closure of the acute oro-antral communication using the Buccal Advancement Flap. Receives: Procedure: Buccal Advancement Flap |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Width of Keratinized Gingiva
Change in keratinized gingival width in millimeters between the preoperative baseline assessment and the three-month postoperative assessment. Keratinized gingival width will be measured between the mucogingival junction and the midpoint of the alveolar ridge using digital intraoral scans obtained with a 3Shape TRIOS 6 intraoral scanner and analyzed using 3D Slicer software.
Measured: Baseline to 3 months after surgery
Secondary outcomes (10)
Successful Closure of the Oro-Antral Communication
Clinical success will be defined as complete closure of the oro-antral communication without persistent communication between the oral cavity and maxillary sinus. The proportion of successfully closed oro-antral communications will be calculated for each study group.
Measured: 14 days after surgery
Postoperative Pain
Participants will record their daily maximum postoperative pain once daily in the afternoon using a visual analog scale from 0 to 10, where 0 represents no pain and 10 represents very severe pain.
Measured: Day 0 through postoperative day 7
Postoperative Swelling
Participants will record their daily maximum postoperative swelling once daily in the afternoon using a visual analog scale from 0 to 10, where 0 represents no swelling and 10 represents very severe swelling.
Measured: Day 0 through postoperative day 7
Postoperative bleeding
Participants will record their daily maximum postoperative bleeding once daily in the afternoon using a visual analog scale from 0 to 10, where 0 represents no postoperative bleeding and 10 represents very severe postoperative bleeding.
Measured: Day 0 through postoperative day 7
Number of Participants with Postoperative Wound dehiscence
Presence or absence of postoperative separation of the sutured buccal and palatal soft tissues will be clinically assessed 14 days after surgery. Participants will be classified as having wound dehiscence if separation of the wound edges is observed. If wound dehiscence is present, its dimensions will additionally be quantified using the intraoral scan.
Measured: 14 days after surgery
Dimensions of Postoperative Wound Dehiscence
Among participants with postoperative wound dehiscence, the maximum dimensions of the separation of the sutured buccal and palatal soft tissues will be measured in milimeters using an intraoral scan 14 days after surgerx.
Measured: 14 days after surgery
Number of Participants with Recurrent or Persistent Oro-Antral Communication
Occurrence of a persistent or recurrent communication between the oral cavity and maxillary sinus during follow-up will be recorded.
Measured: Up to 3 months after surgery
Number of Participants with Postoperative Sinusitis or Infection
Occurrence of clinically diagnosed postoperative maxillary sinusitis or local infection at the follow-up examination after 14 days will be recorded. Clinical signs and symptoms may include facial pain, pressure sensation, purulent nasal discharge, intraoral purulent drainage, fever, or other clinically relevant signs of infection.
Measured: 14 days after surgery
Reoperation rate
Percentage of participants in each study group requiring surgical revision because of insufficient closure of the oro-antral communication.
Measured: 14 days after surgery
Operative time
Duration of the surgical procedure measured from the first surgical incision to completion of the final suture, recorded in minutes and seconds.
Measured: Intraoperatively on Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2026
- Study startOct 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Acute Oroantral CommunicationStudies of the same condition, open and under way.
- More trials run by Medical University of GrazThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized in a 1:1 ratio to surgical closure of the acute oro-antral communication using either the Buccal Periosteal Inversion Flap or the Buccal Advancement Flap.
- Masking
- None (open label)
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Barbara Kirnbauer, PD DDr., Principal investigator, Medical University of GrazNorbert Jakse, Prof. DDr., Study chair, Medical University of Graz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07884331
- Sponsor's protocol ID
- BUPI-BAF Trial
- Status last verified
- Sep 2026
- First submitted
- 13 Oct 2026
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Not applicable at this time.
Publications
Reddy GA, Neelima C, Reddy GS, Charan DG, Samavedam SP. Buccal periosteal inversion flap technique after tooth extraction versus healing by secondary intention for preservation of keratinized gingiva and alveolar ridge: A comparative study. J Maxillofac Oral Surg. April 2025.
Raj G, Raj M, Loh JSP. Pathophysiology and clinical presentation of odontogenic maxillary sinusitis. Dentistry Review. June 2022;2(2):100044.
Cezairli B, Taskesen F, Yilmaz Altintas N. Causes and treatments of oroantral communications: Experience with 103 cases. Ann Med Res. 2021;28(1):204-209.
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.
PubMed 24768423Balicz A, Szurko A, Jedzierowska M, Kielbon A, Wojcik S, Adamczyk J, Starosta M, Fiegler-Rudol J, Morawiec T. Acute Oroantral Communication Closure: Resorbable Collagen Membrane vs. Buccal Advancement Flap Outcomes: A Clinical Trial. J Funct Biomater. 2026 Mar 18;17(3):150. doi: 10.3390/jfb17030150.
PubMed 41893206
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Buccal Periosteal Inversion Flap and Buccal Advancement Flap for the Closure of Acute Oro-Antral Communications: A Prospective Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07884331
- Acronym / sponsor ID
- BUPI-BAF Trial
- Conditions
- Acute Oroantral Communication
- Keywords
- Oro-antral communication, Oroantral communication, Oro-antral fistula, Maxillary sinus, Tooth extraction, Buccal advancement flap, Rehrmann flap, Buccal periosteal inversion flap
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 20 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This prospective randomized controlled clinical trial will compare the Buccal Periosteal Inversion Flap (BUPI) with the Buccal Advancement Flap (BAF) for the primary surgical closure of acute oro-antral communications (OAC) following tooth extraction in the posterior maxilla.
The primary objective is to determine whether the BUPI technique results in better preservation of keratinized gingival width compared with the BAF technique three months after surgery.
Secondary outcomes include successful closure rate of OACs, postoperative pain, swelling and bleeding, wound dehiscence or recurrence of the OAC, postoperative sinusitis or infection, reoperation rate, and operating time.
Participants will be randomly allocated in a 1:1 ratio to either BUPI or BAF. Clinical examinations and intraoral scans will be performed before surgery and at follow-up visits after 14 days, one month, and three months.
Detailed description
An OAC is a pathological communication between the oral cavity and the maxillary sinus and occurs most commonly following extraction of posterior maxillary teeth. Surgical closure is indicated to reduce the risk of maxillary sinusitis.
The Buccal Advancement Flap (BAF) is an established technique for primary closure of acute OACs. However, advancement of the buccal soft tissue results often in a reduction of keratinized gingival width and flattening of the oral vestibule, which may negatively affect subsequent prosthetic or implant treatment.
The Buccal Periosteal Inversion Flap (BUPI) is an alternative technique in which the periosteal layer of a buccal mucoperiosteal flap is separated from the overlying mucosa and inverted to cover the OAC. The overlying mucosa can therefore remain largely in its original position.
The study will prospectively compare both surgical techniques in adult participants presenting with an acute OAC following tooth extraction in the posterior maxilla.
After confirmation of eligibility and written informed consent, participants will undergo a baseline intraoral scan of the relevant quadrant and Periodontal Screening and Recording (PSR) of the relevant sextant. Participants will subsequently be randomized in a 1:1 ratio to BUPI or BAF using the Medical University of Graz randomization system.
The primary endpoint is the change in keratinized gingival width between baseline and three months after surgery. Keratinized gingival width will be measured between the mucogingival junction and the midpoint of the alveolar ridge using digital intraoral scans obtained with a 3Shape TRIOS 6 intraoral scanner. Measurements will be performed using 3D Slicer software.
Participants will document postoperative pain, swelling, and bleeding using a visual analog scale ranging from 0 to 10 on the day of surgery and for the subsequent seven postoperative days.
Clinical follow-up examinations will be performed after 14 days, one month, and three months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomized in a 1:1 ratio to surgical closure of the acute oro-antral communication using either the Buccal Periosteal Inversion Flap or the Buccal Advancement Flap.
| Arm | Type | Receives |
|---|---|---|
| Buccal Periosteal Inversion Flap | Experimental | Procedure: Buccal Periosteal Inversion FlapParticipants assigned to this group will undergo surgical closure of the acute oro-antral communication using the Buccal Periosteal Inversion Flap. |
| Buccal Advancement Flap | Active comparator | Procedure: Buccal Advancement FlapParticipants assigned to this group will undergo surgical closure of the acute oro-antral communication using the Buccal Advancement Flap. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18 years
- Acute Oro-Antral Communication following extraction of posterior maxillary teeth (premolars and molars) within the last 24 hours
- Good general health
- Willingness to attend all scheduled follow-up examinations
Key exclusion criteria (12 listed)
- Age < 18 years
- Acute inflammation or maxillary sinusitis
- Absence of nasal drainage during maxillary sinus irrigation
- Previous surgeries in the study area resulting in scarring
- Systemic diseases that could impair wound healing (e.g. uncontrolled diabetes mellitus)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Buccal Periosteal Inversion FlapAlso: BUPI, Inverted Periosteal Flap, Buccal Periosteal FlapFollowing elevation of a trapezoidal buccal mucoperiosteal flap, the periosteum is dissected from the overlying buccal mucosa from apical to coronal. The mobilized periosteal layer is inverted over the oro-antral communication and sutured to the palatal soft tissue to achieve tension-free closure, while the overlying buccal mucosa is largely maintained in its original position. | Procedure or surgery | Buccal Periosteal Inversion Flap |
| Buccal Advancement FlapAlso: BAF, Rehrmann Flap, Rehrmann PlasticFollowing elevation of a trapezoidal buccal mucoperiosteal flap, the periosteum is incised to allow mobilization of the flap. The entire mucoperiosteal flap is advanced over the oro-antral communication to the palatal soft tissue to achieve tension-free primary closure. | Procedure or surgery | Buccal Advancement Flap |
Primary outcome
Change in Width of Keratinized Gingiva
Time frame: Baseline to 3 months after surgery
Change in keratinized gingival width in millimeters between the preoperative baseline assessment and the three-month postoperative assessment. Keratinized gingival width will be measured between the mucogingival junction and the midpoint of the alveolar ridge using digital intraoral scans obtained with a 3Shape TRIOS 6 intraoral scanner and analyzed using 3D Slicer software.
10 secondary outcomes
Successful Closure of the Oro-Antral Communication
Time frame: 14 days after surgery
Postoperative Pain
Time frame: Day 0 through postoperative day 7
Postoperative Swelling
Time frame: Day 0 through postoperative day 7
Postoperative bleeding
Time frame: Day 0 through postoperative day 7
Number of Participants with Postoperative Wound dehiscence
Time frame: 14 days after surgery
Dimensions of Postoperative Wound Dehiscence
Time frame: 14 days after surgery
Number of Participants with Recurrent or Persistent Oro-Antral Communication
Time frame: Up to 3 months after surgery
Number of Participants with Postoperative Sinusitis or Infection
Time frame: 14 days after surgery
Reoperation rate
Time frame: 14 days after surgery
Operative time
Time frame: Intraoperatively on Day 0
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2026.
- BackgroundReddy GA, Neelima C, Reddy GS, Charan DG, Samavedam SP. Buccal periosteal inversion flap technique after tooth extraction versus healing by secondary intention for preservation of keratinized gingiva and alveolar ridge: A comparative study. J Maxillofac Oral Surg. April 2025.
- BackgroundRaj G, Raj M, Loh JSP. Pathophysiology and clinical presentation of odontogenic maxillary sinusitis. Dentistry Review. June 2022;2(2):100044.
- BackgroundCezairli B, Taskesen F, Yilmaz Altintas N. Causes and treatments of oroantral communications: Experience with 103 cases. Ann Med Res. 2021;28(1):204-209.
- Background: PubMed 24768423Rosenfeld 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.
- Background: PubMed 41893206Balicz A, Szurko A, Jedzierowska M, Kielbon A, Wojcik S, Adamczyk J, Starosta M, Fiegler-Rudol J, Morawiec T. Acute Oroantral Communication Closure: Resorbable Collagen Membrane vs. Buccal Advancement Flap Outcomes: A Clinical Trial. J Funct Biomater. 2026 Mar 18;17(3):150. doi: 10.3390/jfb17030150.
- Individual participant dataSharing planned: Undecided. Not applicable at this time.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Barbara Kirnbauer, PD DDr. principal investigator
Medical University of Graz
Norbert Jakse, Prof. DDr. study chair
Medical University of Graz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Buccal Periosteal Inversion Flap and Buccal Advancement Flap in people with Acute Oroantral Communication, run by Medical University of Graz at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Barbara Kirnbauer, PD DDr. (+43-316-385-30674, barbara.kirnbauer@medunigraz.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Width of Keratinized Gingiva (time frame: Baseline to 3 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07884331, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2026.