Comparison of a Double-layered Technique With the Buccal Sliding Flap for Closure of Oroantral Communication

University of Siena

Status: Enrolling

Conditions: Oroantral Fistula

Study type: Observational

Funder types: Other

Identifiers

NCT05407493

ODO002, 26/06/2020

Details and patient eligibility

About

The aim of this study is to compare the clinical results of combining a pedicle connective palatal flap with a trapezoid buccal flap with the standard buccal flap alone in the closure of oro-antral fistula (OAF), and the buccal flap combined with leukocyte and platelet rich fibrin.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Eligible population among those older than 18 y.o, systemically healthy, with a diagnosis of OAC (OroAntral Communication), or with a strong pre-extractive radiographic suspicion of potential OAC, and associated symptoms (varying among cheek pain with nasal obstruction, purulent rhinorrhea, foul odor, foul taste, headaches, anterior maxillary tenderness, and postnasal drip) .

Exclusion criteria

i) received antibiotic therapy in the last 3 months ii) requiring anticoagulation therapy iii) had systemic diseases that could interfere with oral tissue healing process/bleeding iv) were using bisphosfonates v) were pregnant vi) had mental/physical disabilities vii) underwent radiation treatment to the head or neck region.

Trial design

60 participants in 3 patient groups

Buccal flap

Description:

The buccal flap is slid over the fistula and sutured to the undermined palatal mucosa using horizontal mattress sutures.

Double-layer

Description:

A combination between a buccal trapezoidal flap and a palatal connective pedicle flap.

Buccal flap with L-PRF

Description:

A L-PRF plug is interposed between the fistula and the buccal sliding flap.