A Hinge Flap to Reinforce Buccal Advancement Flap
ConditionOroantral Fistula
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorQassim University
About this trial
Background The chronic oroantral fistulas (COAF) is an epithelized communication that is formed between the squamous epithelium of the oral cavity and the pseudo-stratified columnar ciliated epithelium of the maxillary sinus with a high recurrent rate. The use of palatal flaps has been documented for treating such fistulae. The presence of the oroantral fistula at the area of second molars or maxillary tuberosity could complicate the use of the palatal rotational flap where the arch of its rotation is increased leading to compromised blood supply. The use of the buccal flap is not advocated because it is very thin.
Rationale Double or triple-layer closure is indicated to avoid recurrence of the COAF. Different layers have been documented to minimize the risk of recurrence and reinforce buccal flaps. The oral tissues at the oral side of the oroantral fistula could used as an additional layer with buccal advancement flap and buccal fat to omit the use of palatal flap with its subsequent problems in the most posterior aspect of the maxilla Study objectives Therefore, this study will be conducted to evaluate the use of hinge flaps to reinforce the buccal advancement flap for surgical closure of the COAF in the most posterior area of the maxilla
Methods The hinge flap will be performed at the oral side of the COAF to close the perforation in the sinus membrane. The oral side of the COAF will be closed with buccal advancement flap. The success rate, recurrence, time of surgery, postoperative complications, will be evaluated.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Chronic oroantral fistula at the most posterior area of the maxilla
Ages above 18 years
Patients who are medical free
Disqualifiers
Oroantral communications
Absence of sinus infection
Oroantral fistula which are resulted from tumor resections
Trial design
Design model
Parallel
Treatments tested in this trial
A hinge flap will be performed to reinforce the buccal advancement flap to close the oroantral fistula at the most posterior area of the maxilla
Procedure/SurgeryThe hinge flap is raised via circular incision around the oral side of the oroantral fistula then sutured with purse suture to close the sinus membrane perforation and it is used as an additional layer that reinforce the buccal advancement flap
An anteriorly based palatal flap will be performed to close the oroantral fistula at the most posterior area of the maxilla
Procedure/SurgeryTwo paralleling incisions will be performed on the palatal side of the fistula. The distance between the two incisions will be 2 to 3 mm greater than the width of the fistula. Then the two incisions will be connected together via a circular incision at the bony end of the hard palate. The flap reflection will be performed, and the greater palatine vessels will be legated and cauterized to allow lateral repositioning of the flap over the fistula. The flap will be sutured to the buccal tissues.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Hinge Flap groupExperimental treatment 1 intervention
Group B: Palatal Flap groupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Duration of Surgery
The time elapsed from the initial incision to final closure of the flap. The time will be calculated in minutes. The mean and standard deviation will be then calculated and used to compare between the study's arms.A prolonged time means worse outcomes
Time frame
30 minutes2
Difficulties during surgeries
Surgical difficulties scoring system will be used.Surgical difficulty was assessed by the operator using an index of 1-10 with the following divisions: 1-3 low difficulty, 4-6 intermediate difficulty, and 7-10 high difficulty. A low difficulty score means a better outcome
Time frame
60 minutes3
Recurrence of the Oroantral fistula
The patients will be followed after surgery for the success or failure of the surgical closure. The follow-up will be weekly in the first month, and then monthly in the next three months.The recurrence means worse outcomes
Time frame
At the end of the postoperative fourth monthSecondary outcomes
1
Patients' satisfaction
A patient satisfaction survey is a set of questions used to collect feedback from patients to measure their satisfaction with the quality and care of the healthcare service provider.Based on their responses, patients will be divided into three categories: Promoters (9-10), Passives (7-8), and Detractors (0-6).
Time frame
At the end of the fourth month after surgerySponsors and contacts
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Source ClinicalTrials.gov